pbio_10k.htm


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
Form 10-K
 
(Mark One)
 
þ
Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
For the fiscal year ended December 31, 2013 or
 
o
Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
For the transition period from __________ to _________
 
Commission file number  000-21615
 
PRESSURE BIOSCIENCES, INC.
(Exact Name of Registrant as Specified in its Charter)

Massachusetts
 
04-2652826
(State or Other Jurisdiction of Incorporation or Organization)
 
(I.R.S. Employer Identification No.)
     
14 Norfolk Avenue South Easton, Massachusetts
 
02375
(Address of Principal Executive Offices)
 
( Zip Code)
     
(508) 230-1828
   
(Registrant’s Telephone Number, Including Area Code)
   
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of Each Class
 
Name of Each Exchange on Which Registered
 Common Stock, par value $.01 per share
Preferred Share Purchase Rights
 
OTC Markets Group Inc
 
Securities registered pursuant to Section 12(g) of the Act:
__________________________
(Title of Class)
 
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes o No þ

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes o No þ

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No o

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that registrant was required to submit and post such files. Yes þ No o
 
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. o
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
 
Large accelerated filer o Accelerated filer o
Non-accelerated filer o Smaller reporting company  þ
(Do not check if smaller reporting company)
   
 
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No þ

The aggregate market value of the voting and non-voting Common Stock held by non-affiliates of the registrant as of June 30, 2013 was  $3,640,182  based on the closing price of $0.34 per share of Pressure BioSciences, Inc. Common Stock as quoted on the OTC Markets QB exchange on that date.

As of March 31, 2014, there were 12,624,267 shares of the registrant’s Common Stock outstanding.

Documents Incorporated by Reference
N/A.
 
 

 
 
TABLE OF CONTENTS
 
PART I
         
ITEM 1. 
BUSINESS.  
    4  
           
ITEM 1A.
RISK FACTORS
    17  
           
ITEM 1B. 
UNRESOLVED STAFF COMMENTS.  
    26  
           
ITEM 2. 
PROPERTIES. 
    26  
           
ITEM 3. 
LEGAL PROCEEDINGS.  
    26  
           
ITEM 4. 
MINE SAFETY DISCLOSURES  
    26  
           
PART II
           
ITEM 5. 
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITY SECURITIES.  
    27  
           
ITEM 6. 
SELECTED FINANCIAL DATA.  
    29  
           
ITEM 7. 
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION. 
    29  
           
ITEM 7A.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
    38  
           
ITEM 8. 
FINANCIAL STATEMENTS AND SUPPLIMENTARY DATA.  
    39  
           
ITEM 9. 
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE. 
    77  
           
ITEM 9A. 
CONTROLS AND PROCEDURES
    77  
           
ITEM 9B. 
OTHER INFORMATION.  
    78  
           
PART III
           
ITEM 10. 
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.  
    79  
           
ITEM 11. 
EXECUTIVE COMPENSATION.  
    83  
           
ITEM 12. 
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.  
    88  
           
ITEM 13. 
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS; AND DIRECTOR INDEPENDENCE. 
    89  
           
ITEM 14. 
PRINCIPAL ACCOUNTING FEES AND SERVICES  
    89  
           
PART IV
           
ITEM 15
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES. 
    90  

 
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Introductory Comment

Throughout this Annual Report on Form 10-K, the terms “we,” “us,” “our,” “the Company” and “our company” refer to Pressure BioSciences, Inc., a Massachusetts corporation, and unless the context indicates otherwise, also includes our wholly-owned subsidiary.

PART I

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In some cases, forward-looking statements are identified by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar expressions intended to identify forward-looking statements. Such statements include, without limitation, statements regarding:

  
our need for, and our ability to raise, additional equity or debt financing on acceptable terms, if at all;
  
our need to take additional cost reduction measures, cease operations or sell our operating assets, if we are unable to obtain sufficient additional financing;
  
our belief that we have sufficient liquidity to finance normal operations until August 2014;
  
the options we may pursue in light of our financial condition;
  
the amount of cash necessary to operate our business;
  
the anticipated uses of grant revenue and the potential for increased grant revenue in future periods;
  
our plans and expectations with respect to our continued operations;
  
our belief that PCT has achieved initial market acceptance in the mass spectrometry and other markets;
  
the expected increase in the number of pressure cycling technology (“PCT”) and constant pressure (“CP”) based  units installed and the increase in revenues from the sale of consumable products and extended service contracts;
  
the expected development and success of new instrument and consumables product offerings;
  
the potential applications for our instrument and consumables product offerings;
  
the expected expenses of, and benefits and results from, our research and development efforts;
  
the expected benefits and results from our collaboration programs, strategic alliances and joint ventures;
  
our expectation of obtaining additional research grants from the government in the future;
  
our expectations of the results of our development activities funded by government research grants;
  
the potential size of the market for biological sample preparation;
  
general economic conditions;
  
the anticipated future financial performance and business operations of our company;
  
our reasons for focusing our resources in the market for genomic, proteomic, lipidomic and small molecule sample preparation;
  
the importance of mass spectrometry as a laboratory tool;
  
the advantages of PCT over other current technologies as a method of biological sample preparation in biomarker discovery, forensics, and histology and for other applications;
  
the capabilities and benefits of our PCT sample preparation system, consumables and other products;
  
our belief that laboratory scientists will achieve results comparable with those reported to date by certain research scientists who have published or presented publicly on PCT and our other products;
  
our ability to retain our core group of scientific, administrative and sales personnel; and
  
our ability to expand our customer base in sample preparation and for other applications of PCT and our other products.

These forward-looking statements are only predictions and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements, expressed or implied, by such forward-looking statements. Also, these forward-looking statements represent our estimates and assumptions only as of the date of this Annual Report on Form 10-K. Except as otherwise required by law, we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement contained in this Annual Report on Form 10-K to reflect any change in our expectations or any change in events, conditions or circumstances on which any of our forward-looking statements are based. Factors that could cause or contribute to differences in our future financial and other results include those discussed in the risk factors set forth in Part I, Item 1A of this Annual Report on Form 10-K as well as those discussed elsewhere in this Annual Report on Form 10-K. We qualify all of our forward-looking statements by these cautionary statements.
 
 
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A.  
ITEM 1.                      BUSINESS.
 
Throughout this document we use the following terms: Barocycler®, PULSE®, and BioSeq®, which are registered trademarks of the Company. We also use the terms ProteoSolveTM, ProteoSolveLRSTM, the Power of PCTTM and the PCT ShredderTM, all of which are unregistered trademarks of the Company.

Overview

We are focused on solving the challenging problems inherent in biological sample preparation, a crucial laboratory step performed by scientists worldwide working in biological life sciences research. Sample preparation is a term that refers to a wide range of activities that precede most forms of scientific analysis. Sample preparation is often complex, time-consuming and, in our belief, one of the most error-prone steps of scientific research. It is a widely-used laboratory undertaking – the requirements of which drive what we believe is a large and growing worldwide market. We have developed and patented a novel, enabling technology platform that can control the sample preparation process. It is based on harnessing the unique properties of high hydrostatic pressure. This process, called pressure cycling technology, or PCT, uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels i.e., 35,000 pounds per square inch (“psi”) or greater to safely, conveniently and reproducibly control the actions of molecules in biological samples, such as cells and tissues from human, animal, plant and microbial sources.

Our pressure cycling technology uses internally developed instrumentation that is capable of cycling pressure between ambient and ultra-high levels at controlled temperatures and specific time intervals, to rapidly and repeatedly control the interactions of bio-molecules, such as deoxyribonucleic acid (“DNA”), ribonucleic acid (“RNA”), proteins, lipids and small molecules. Our laboratory instrument, the Barocycler®, and our internally developed consumables product line, which include our Pressure Used to Lyse Samples for Extraction (“PULSE”) tubes, and other processing tubes, and application specific kits such as consumable products and reagents, together make up our PCT Sample Preparation System (“PCT SPS”).

We hold 14 United States and 10 foreign patents covering multiple applications of PCT in the life sciences field. Our pressure cycling technology employs a unique approach that we believe has the potential for broad use in a number of established and emerging life sciences areas, which include:

  
biological sample preparation in such study areas as genomic, proteomic, lipidomic, metabolomic and small molecule;
  
pathogen inactivation;
  
protein purification;
  
control of chemical reactions, particularly enzymatic; and
  
immunodiagnostics.

We are also the exclusive distributor throughout all of the Americas for the Constant Systems cell disruption equipment, parts, and consumables.  Constant Systems, Ltd (“CS”), a British company located about 90 minutes northwest of London, England, has been providing niche biomedical equipment, related consumable products, and services to a global client base since 1989. CS designs, develops, and manufactures high pressure cell disruption equipment required by life sciences laboratories worldwide, particularly disruption systems for the extraction of proteins. The CS equipment provides a constant and controlled cell disruptive environment, giving the user superior, constant, and reproducible results whatever the application. CS has nearly 900 units installed in over 40 countries worldwide. The CS cell disruption equipment has proven performance in the extraction of cellular components, such as protein from yeast, bacteria, mammalian cells, and other sample types.

The CS pressure-based cell disruption equipment and the PBI PCT instrumentation complement each other in several important ways.  While both the CS and PBI technologies are based on high pressure, each product line has fundamental scientific capabilities that the other does not offer.  PBI’s PCT Platform uses certain patented pressure mechanisms to achieve small-scale, molecular level effects.  CS’s technology uses different, proprietary pressure mechanisms for larger-scale, non-molecular level processing.  In a number of routine laboratory applications, such as protein extraction, both effects can be critical to success. Therefore, for protein extraction and a number of other important scientific applications, we believe laboratories will benefit by using the CS and PBI products, either separately or together.

 
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Within the broad field of biological sample preparation, we focus the majority of our PCT and CP product development efforts in three specific areas: biomarker discovery (primarily through mass spectrometric analysis), forensics and histology.
 
  
Biomarker Discovery - Mass Spectrometry. A biomarker is any substance (e.g., protein) that can be used as an indicator of the presence or absence of a particular disease-state or condition, to measure disease progression, and to measure the effects of therapy.  Biomarkers can help in the diagnosis, prognosis, therapy, prevention, surveillance, control, and cure of diseases and medical conditions.

A mass spectrometer is one of the laboratory instruments used in the analysis of biological samples, primarily proteins, in life sciences research. It is frequently used to help discover biomarkers. According to a recently published market report by Transparency Market Research (www.transparencymarketresearch.com) "Spectrometry Market (Atomic, Molecular and Mass Spectrometry) - Global Scenario, Trends, Industry Analysis, Size, Share & Forecast 2011 – 2017," the global spectrometry market was worth $10.2 billion in 2011 and is expected to reach $15.2 billion in 2017, growing at a compound annual growth rate of 6.9% from 2011 to 2017. In the overall global market, the North American market is expected to maintain its lead position in terms of revenue until 2017 and is expected to have approximately 36.2% of the market revenue share in 2017 followed by Europe. We believe that both PCT and CP based products offer significant advantages in speed and quality compared with current techniques used in the preparation of samples for mass spectrometry analysis.
 
  
Forensics. The detection of DNA has become a part of the analysis of forensic samples by laboratories and criminal justice agencies worldwide in their efforts to identify the perpetrators of violent crimes and missing persons. Scientists from the University of North Texas and Florida International University have reported improvements in DNA yield from forensic samples e.g., bone, and hair, using PCT in the sample preparation process. We believe PCT may be capable of differentially extracting DNA from sperm and female epithelial cells in swabs collected from rape victims and stored in rape kits. According to the Joyful Arts Foundation’s website, an organization focused on bringing justice to all victims of rape cases that remain unsolved (http://endthebacklog.org/whatisthebacklog.htm), “Experts in the federal government estimate that there are hundreds of thousands of untested rape kits in police and crime lab storage facilities throughout the United States.” We believe this backlog exists for reasons such as cost, processing time and quality of results. We further believe that the ability to differentially extract DNA from the sperm while not extracting DNA from the female epithelial cells could reduce the cost of such testing, while increasing quality, safety and speed.

  
Histology. The most commonly used technique worldwide for the preservation of biopsies of cancer and other tissues for subsequent pathology evaluation is formalin-fixation followed by paraffin-embedding (“FFPE”). We believe that the quality and analysis of FFPE tissues is highly problematic. We believe PCT offers significant advantages over current processing methods, which include standardization, speed, biomolecule recovery and safety.

Our customers include researchers at academic laboratories, government agencies, biotechnology, pharmaceutical and other life sciences companies in the United States, and distribution partners in foreign countries.

We have experienced negative cash flows from operations with respect to our business since inception. As of December 31, 2013, we did not have adequate working capital resources to satisfy our current liabilities. Based on our current projections, including equity financing subsequent to December 31, 2013, we believe our current cash resources will enable us to extend our cash resources until August 2014.

As a result, the audit report issued by our independent registered public accounting firm on our audited consolidated financial statements for the fiscal year ended December 31, 2013, contains an explanatory paragraph regarding our ability to continue as a going concern. The audit report issued by our independent registered public accounting firm for our financial statements for the fiscal year ended December 31, 2013 states that our auditing firm has substantial doubt in our ability to continue as a going concern due to the risk that we may not have sufficient cash and liquid assets to cover our operating and capital requirements for the next twelve-month period; and, if sufficient cash cannot be obtained, we would have to substantially alter, or possibly even discontinue, operations. The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty.

The conditions described above could adversely affect our ability to obtain additional financing on favorable terms, if at all, and may cause investors to have reservations about our long-term prospects, and may adversely affect our relationships with customers. There can be no assurance that our auditing firm will not qualify its opinion in the future. If we cannot successfully continue as a going concern, our stockholders may lose their entire investment in us.
 
 
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Developments
 
Despite the continued uncertainty in the capital markets during 2013 that negatively affected the overall capital budgets of our existing and prospective customers, and notwithstanding our limited financial resources during such time, we reported a number of accomplishments during 2013 including:

2013
 
  
On December 12th, we filed a current report on Form 8K relating to the close of the first tranche ($1 million) of a $1.5 million Convertible Preferred Stock and Common Warrant transaction.
 
  
On November 7th, we announced Q3 2013 financial results, including record quarterly total revenue, record quarterly products and services revenue, record quarterly consumable sales, and record quarterly Shredder Systems sales.
 
  
On August 1st, we reported that scientists from UCLA presented data at an international scientific symposium on an advanced pressure-based instrument system for biomarker discovery and rational drug design that we believe could offer new insights into protein structure and function.
  
  
On June 14th, we announced the close of the third and final tranche of our Series J $2.0 million Private Placement of Preferred Stock and Warrants; we also announced the closing of a $500,000 one-year convertible debenture with an institutional investor.

  
On June 4th, we announced a core technology breakthrough; that we had succeeded in reaching a pivotal development in our PCT platform that will allow the processing of the high throughput multiwell format found in research (and clinical) laboratories worldwide and that we expected this novel design would have a significant impact on our future growth.

  
On May 21st, we announced financial results for Q1 2013: total revenue increased 21% over the Q1 2012, consumable sales increased 64% over Q1 2012, and operating loss decreased 24% compared to Q1 2013.

  
On May 20th we closed the third and final tranche of an over-subscribed $1.5 million Convertible Preferred Stock and Common Warrant transaction, in which the Company received a total of $2,034,700.

  
On May 16th, we reported the publication of a breakthrough method for lipid analysis in fecal material, developed by a team led by Dr. Bruce Kristal (Harvard Medical School and the Brigham and Women’s Hospital).  We believe that this new method can help increase the understanding of diseases and disorders related to gastrointestinal (GI) disorders.

  
On April 4th, we announced that further advances had been made in the development of an improved method for rape kit sample testing using PBI’s PCT Platform by Dr. Bruce McCord and his team at the International Forensic Research Institute of Florida International University.

  
On March 19th, we announced that the use and advantages of PBI’s PCT Platform had been highlighted in cancer, stem cell, and heart disease studies at an important protein research conference.  We believe that the FDA data indicate that PCT can be used to extract proteins from stem cells with consistency and quality; the Johns Hopkins data indicate that combining PCT with heat might be a way to recover significantly more proteins from FFPE tissues compared to standard (heat) methods, especially membrane proteins (this could be very important with scientists looking for disease biomarkers); and the ETH Zurich data might be significant for extracting proteins from small, needle biopsy samples, something that we believe is vitally needed today yet not well satisfied at the present time, and (we believe) a significant market opportunity. 

  
On February 12th, we announced that Dr. Mickey Urdea had been appointed to the Board of Directors of PBI.  Dr. Urdea is one of the most well-known entrepreneurs and leaders in biotechnology today, having founded two successful companies (Halteres Associates and Tethys Bioscience) over the past ten years.  Earlier in his career, Dr. Urdea led the infectious diseases R&D groups at Chiron Corporation and Bayer Diagnostics.  He has also been on the Scientific Advisory Boards of numerous life sciences companies and has been an advisor and consultant to the Bill and Melinda Gates Foundation Diagnostic Forum.
 
 
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Liquidity
 
Management has developed a plan to continue operations. This plan includes reducing expenses, streamlining operations, and obtaining capital through an equity and/or debt financing including our most recently completed financing on February 28, 2014 (the “Series K Private Placement”). In the Series K Private Placement, we sold units consisting of Preferred Stock convertible into the Company’s Common Stock (“Common Stock”) and warrants to purchase shares of Common Stock for net aggregate proceeds of approximately $2,849,110 in three tranches of $1,000,000, $1,218,750 and $630,360, respectively. Although we have successfully completed equity financings and reduced expenses in the past, we cannot assure our investors that our plans to address these matters in the future will be successful. Additional financing may not be available to us on a timely basis or on terms acceptable to us, if at all. In the event we are unable to raise sufficient funds on terms acceptable to us, we may be required to:

  
severely limit or cease our operations or otherwise reduce planned expenditures and forego other business opportunities, which could harm our business. The accompanying financial statements do not include adjustments that may be required in the event of the disposal of assets or the discontinuation of the business;
  
obtain financing with terms that may have the effect of diluting or adversely affecting the holdings or the rights of the holders of our capital stock; or obtain funds through arrangements with future collaboration partners or others that may require us to relinquish rights to some or all of our technologies or products;
  
or obtain funds through arrangements with future collaboration partners or others that may require us to relinquish rights to some or all of our technologies or products.

Corporate Information
 
We were incorporated in the Commonwealth of Massachusetts in August 1978 as Boston Biomedica, Inc. In September 2004, we completed the sale of Boston Biomedica’s core business units and began to focus exclusively on the development and commercialization of the PCT platform. Following this change in business strategy, we changed our legal name from Boston Biomedica, Inc. to Pressure BioSciences, Inc. (“PBI”). We began operations as PBI in February 2005, research and development activities in April 2006, early marketing and selling activities of our Barocycler instruments in late 2007, and aggressive marketing and selling of our PCT-based instrument platform in 2012.

Available Information
 
Our Internet website address is http://www.pressurebiosciences.com. Through our website, we make available, free of charge, reports we file with the Securities and Exchange Commission (“SEC”), which include, but are not limited to, our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and any and all amendments to such reports, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. These SEC reports can be also accessed through the investor relations section of our website. The information found on our website is not part of this or any other report we file with or furnish to the SEC.

You may read and copy any materials we file with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549. You may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC also maintains an Internet website that contains reports, proxy and information statements and other information regarding Pressure BioSciences and other issuers that file electronically with the SEC. The SEC’s Internet website address is http://www.sec.gov.

Sample Preparation for Genomic, Proteomic, Lipidomic and Small Molecule Studies
 
The Market
 
Since February 2005, we have focused substantially all of our research and development and commercialization efforts on sample preparation for genomic, proteomic, lipidomic, and small molecule studies. This market is comprised of academic and government research institutions, biotechnology and pharmaceutical companies, and other public and private laboratories that are engaged in studying genomic, proteomic and small molecule material within plant and animal cells, and tissues. We elected to initially focus our resources in the market of genomic, proteomic and small molecule sample preparation because we believe it is an area that:
 
 
7

 
 
  
is a rapidly growing market;
  
has a large and immediate need for better technology;
  
is comprised mostly of research laboratories, which are subject to minimal governmental regulation;
  
is the least technically challenging application for the development of our products;
  
is compatible with our technical core competency; and
  
we currently have strong patent protection.

We believe that our existing PCT and CP-based instrumentation and related consumable products fill an important and growing need in the sample preparation market for the safe, rapid, versatile, reproducible and quality extraction of nucleic acids, proteins and small molecules from a wide variety of plant and animal cells and tissues.

Biomarker Discovery - Mass Spectrometry
 
      A biomarker is any substance (e.g., protein) that can be used as an indicator of the presence or absence of a particular disease-state or condition, and to measure the progression and effects of therapy.  Biomarkers can help in the diagnosis, prognosis, therapy, prevention, surveillance, control, and cure of diseases and medical conditions.
 
       A mass spectrometer is a laboratory instrument used in the analysis of biological samples, primarily proteins, in life sciences research. It is frequently used to help discover biomarkers. According to a recently published market report by Transparency Market Research (www.transparencymarketresearch.com) "Spectrometry Market (Atomic, Molecular and Mass Spectrometry) - Global Scenario, Trends, Industry Analysis, Size, Share & Forecast 2011 – 2017," the global spectrometry market was worth $10.2 billion in 2011 and is expected to reach $15.2 billion in 2017, growing at a compound annual growth rate of 6.9% from 2011 to 2017. In the overall global market, the North American market is expected to maintain its lead position in terms of revenue till 2017 and is expected to have approximately 36.2% of the market revenue share in 2017 followed by Europe. We believe PCT and CP-based products offes significant advantages in speed and quality compared with current techniques used in the preparation of samples for mass spectrometry analysis.
 
Our plan is to focus primarily on the application of PCT-enhanced protein extraction and CP-based digestion for the mass spectrometry market and the advantages of PCT and CP in this market, and the use of PCT and CP in biomarker discovery, soil and plant biology, counter bio-terrorism and tissue pathology applications.

Forensics
 
The detection of DNA has become a part of the analysis of forensic samples by laboratories and criminal justice agencies worldwide in their efforts to identify the perpetrators of violent crimes and missing persons. Scientists from the University of North Texas and Florida International University have reported improvements in DNA yield from forensic samples e.g., bone and hair using PCT in the sample preparation process. We believe that PCT may be capable of differentially extracting DNA from sperm and female epithelial cells in swabs collected from rape victims and stored in rape kits. We also believe that there are many completed rape kits that remain untested for reasons such as cost, time and quality of results. We further believe that the ability to differentially extract DNA from sperm and not epithelial cells could reduce the cost of such testing, while increasing quality, safety and speed.

Histology
 
The most commonly used technique worldwide for the preservation of cancer and other tissues for subsequent pathology evaluation is formalin-fixation followed by paraffin-embedding, or FFPE. We believe that the quality and analysis of FFPE tissues is highly problematic, and that PCT offers significant advantages over current processing methods, including standardization, speed, biomolecule recovery, and safety.

Sample Extraction Process
 
The process of preparing samples for genomic, proteomic and small molecule studies includes a crucial step called sample extraction or sample disruption. This is the process of extracting nucleic acid i.e., DNA and/or RNA, proteins or small molecules from the plant or animal cells and tissues that are being studied. Sample preparation is widely regarded as a significant impediment to research and discovery and sample extraction is generally regarded as the key part of sample preparation. Our current commercialization efforts are based upon our belief that pressure cycling technology provides a superior solution to sample extraction compared with other available technologies or procedures and can thus significantly improve the quality of sample preparation.

 
8

 
 
Collaboration Program
 
Our collaboration program is an important element of our business strategy. Initiating a collaboration with a researcher involves the installation of a Barocycler instrument for an agreed upon period of time of approximately three to six months, and the execution of an agreed upon work plan. Our primary objectives for entering into a collaboration agreement include:

  
the development of a new application for PCT and CP in sample preparation;
  
the advancement and validation of our understanding of PCT and CP within an area of life sciences in which we already offer products;
  
the demonstration of the effectiveness of PCT and CP to specific research scientists who we believe can have a positive impact on market acceptance of PCT; and
  
the expectation of peer-reviewed publications and/or presentations at scientific meetings by a third party on the merits of PCT and CP.

Since we initiated our collaboration program in June 2005, third party researchers have cited the use of our PCT platform in publications and presentations. We believe that this program has provided and continues to provide us with independent and objective data about PCT from well-respected laboratories in the United States and throughout the rest of the world.

Company Products
 
We believe our PCT and CP products allow researchers to improve scientific research studies in the life sciences field. Our products are developed with the expectation of meeting or exceeding the needs of research scientists while enhancing the safety, speed and quality that is available to them with existing sample preparation technology.

Barocycler Instrumentation
 
Our Barocycler product line consists of laboratory instrumentation that subjects a sample to cycles of pressure from ambient to ultra-high levels and then back to ambient; all in a precisely controlled manner. Our instruments, the Barocycler NEP3229 and Barocycler NEP2320, use cycles of high, hydrostatic pressure to quickly and efficiently break up the cellular structures of a specimen to release nucleic acids, proteins, lipids and small molecules from the specimen into our consumable processing tube, referred to as our PULSE Tubes. Our Barocycler instrumentation is designed to fit on a laboratory bench top, inside a biological safety cabinet, or on the shelf of a laboratory cold room. Our instruments have an external chiller hook-up (to control temperature during the PCT process), automatic fill and dispensing valves, and an integrated micro-processor keypad. The microprocessor is capable of saving up to 99 specific PCT protocols; so, the researcher can achieve maximum reproducibility for the extraction of nucleic acids, proteins, lipids, or small molecules from various biological samples. Our Barocycler instruments and our consumable products make up our current PCT Sample Preparation System (See below).

Barocycler NEP3229 – The Barocycler NEP3229 contains two units – a user interface and a power source – comprised primarily of a 1.5 horsepower motor and pump assembly (hydraulic). Combined, the two components of the NEP3229 weigh approximately 350 pounds.  The Barocycler NEP3229 is capable of processing up to three samples simultaneously using our specially designed, single-use PULSE Tubes and up to 48 samples simultaneously using our specially-designed MicroTubes.

Barocycler NEP2320 – The Barocycler NEP2320 is a smaller, more compact version of our NEP3229 unit. It weighs approximately 80 pounds (with accessories), and works on compressed air (pneumatic) instead of hydraulics like the larger NEP3229 unit.  Because this instrument is pneumatic, the NEP2320 can be easily attached by an air hose to a typical 85 psi air compressor found in most scientific laboratories as well as many consumer-sold portable compressors or even to bottled gas.  This instrument is used by our sales directors as a demonstration instrument and is marketed as a second instrument alternative to our PCT SPS.  The Barocycler NEP2320 is capable of processing one sample at a time using our specially designed, single-use PULSE Tubes and up to 16 samples simultaneously using our specially-designed MicroTubes.

Barocycler HUB440 – The Barocycler HUB440 was introduced to collaborators in the electron paramagnetic resonance (“EPR”) market in 2011 for testing in a laboratory environment, and to elicit feedback from research scientists on performance and capabilities.  The Barocycler HUB440 is capable of creating and controlling hydrostatic pressure from 35 Bar (500 psi) to 4,000 Bar (58,000 psi).  It is computer controlled, and runs on software that was specially-written by PBI in LabVIEW (by National Instruments Corporation). PBI owns the rights and has a license to use the specialty LabVIEW software. The Barocycler HUB440 is the first portable, ready to use pressure generator for the laboratory bench.  We believe that over the coming years, the Barocycler HUB440 will be the main instrument in the Company’s pressure-based instrument line.
 
 
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PCT MicroTube Adapter Kit – The PCT MicroTube Adapter Kit includes an ergonomically designed, space-saving Workstation, PCT MicroTubes and MicroCaps, and specialized tools to enable the user to process up to forty-eight samples simultaneously in our PCT SPS, as compared to three with the Barocycler NEP3229.

The Shredder SG3The Shredder SG3 is a low shear mechanical homogenization system for use with tough, fibrous and other difficult-to-disrupt tissues and organisms.  The Shredder SG3 System uses a variety of Shredder PULSE Tubes to directly and rapidly grind a biological sample which, when combined with selected buffers, can provide effective extraction of proteins, DNA, RNA, lipids and small molecules from tissues and organisms.  The Shredder SG3 features a three position force setting lever, which enables the operator to select and apply reproducible force to the sample during the shredding process and eliminates the need for the operator to exert force for long periods when processing one or more samples.

Cell Disruption Instrumentation
 
We are also the exclusive distributor throughout all of the Americas for the Constant Systems cell disruption equipment, parts, and consumables. Constant Systems, Ltd (“CS”), a British company located about 90 minutes northwest of London, England, has been providing niche biomedical equipment, related consumable products, and services to a global client base since 1989. CS designs, develops, and manufactures high pressure cell disruption equipment required by life sciences laboratories worldwide, particularly disruption systems for the extraction of proteins. The CS equipment provides a constant and controlled cell disruptive environment, giving the user superior, constant, and reproducible results whatever the application. CS has nearly 900 units installed in over 40 countries worldwide. The CS cell disruption equipment has proven performance in the extraction of cellular components, such as protein from yeast, bacteria, mammalian cells, and other sample types.

The CS pressure-based cell disruption equipment and the PBI PCT instrumentation complement each other in several important ways.  While both the CS and PBI technologies are based on high pressure, each product line has fundamental scientific capabilities that the other does not offer.  PBI’s PCT Platform uses certain patented pressure mechanisms to achieve small-scale, molecular level effects.  CS’s technology uses different, proprietary pressure mechanisms for larger-scale, non-molecular level processing.  In a number of routine laboratory applications, such as protein extraction, both effects can be critical to success. Therefore, for protein extraction and a number of other important scientific applications, we believe laboratories will benefit by using the CS and PBI products, either separately or together.

Baracycler Consumable Products
 
PULSE Tubes (FT500) – The FT500 PULSE Tube is a specially-designed, plastic, single-use, processing container with two chambers separated by a small disk with small holes.  This small disk is referred to as a Lysis Disk.  PULSE Tubes transmit the power of PCT from the Barocycler instrument to the sample.  In sample extraction, the specimen is placed on the Lysis Disk.  Buffers are added to the PULSE tube and the PULSE Tube is capped and placed in the pressure chamber of the Barocycler instrument.  The pressure chamber fluid then is added and pressurization begins.  As pressure increases, a small moveable piston pushes the specimen from the top (sample) chamber, through the Lysis Disk and into the bottom (fluid retention) chamber.  When pressure is released, the sample, which is now partially homogenized, is pulled back through the Lysis Disk by the receding ram.  The combination of physical passage through the Lysis Disk, rapid pressure changes and other biophysical mechanisms related to cycled pressure break up the cellular structures of the specimen to quickly and efficiently release nucleic acids, proteins, lipids and small molecules.

Non-Disk PULSE Tubes (FT500-ND) – The FT500-ND PULSE Tube is a specially-designed, plastic, single-use, processing container with one chamber separated by a small disk with small holes.  The FT500-ND is similar to the FT500 in look and feel, except there is no Lysis Disk separating the body of the processing container into two chambers, as in the FT500.  The design change was based on market demand for a PCT consumable for the rapid and reproducible processing of solutions and suspensions that do not require partial homogenization by passage through a Lysis Disk and for a consumable that could accept smaller sample volumes.  The FT500-ND offers variable sample volumes with a range five times that of the existing FT500.

 
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ProteoSolve - SB – (ProteoSolve for Systems Biology) is a PCT-dependent method for the simultaneous extraction, isolation and fractionation of nucleic acids (DNA and RNA), proteins and lipids from animal and plant samples routinely used in laboratory research.  This patent-pending kit contains proprietary reagents, consumable processing containers (PULSE Tubes) and instructions for use.  It is intended to be used with our patented PCT Sample Preparation System.  The kit is based on an approach to a "systems biology" sample preparation method that was first unveiled during early 2008 in collaboration with Dr. Alexander Ivanov, who was then with the Harvard School of Public Health.

ProteoSolve - CE – (ProteoSolve for Conventional Extraction) is a PCT-dependent kit for the extraction of proteins from a variety of samples using optimized detergent-based reagent system compatible with two-dimensional electrophoresis or two-dimensional chromatographic separation for proteomic analysis.  The kit contains the reagents and instructions necessary for the extraction of either denatured or non-denatured proteins, which can then be used for the analysis of protein structure and function.

Mitochondria Isolation Kits – These kits contain the chemical ingredients necessary for a scientist to extract mitochondria from skeletal muscle and lung tissue for subsequent analysis.  Mitochondria play a major role in generating the energy required to power most cell processes and are involved in other important cell functions. Mitochondria have been implicated in several human diseases, including heart disease, stroke, Parkinson's disease, cancer and other mitochondrial diseases.

We believe our development of these products has helped, and will continue to help, drive the adoption of PCT within the life sciences market.

Company Services
 
Government Grants and Contracts
 
We view federal agency grants to be an important part of our business plan.  These types of grants allow us to bill the federal agency for work that we are planning to perform as part of the development and commercialization of our technology.  We generally start by submitting initial grant requests that are in response to requests for proposals (“RFPs”) from the federal government through their Small Business Innovation Research (“SBIR”) program.  Initial (“SBIR Phase I”) grants are meant to fund approved research projects for six months, and generally have budgets of approximately $100,000 to $150,000.  Because our work in SBIR Phase I grants has been successful, we have applied, and may in the future apply for larger National Institutes of Health (“NIH”) SBIR Phase II grants.  Such larger grants are typically for a two-year period and can offer as much as $1,000,000 to support significant research projects in areas we would otherwise expect to support with internal funds should SBIR Phase II grants not be awarded.  To date, we have been awarded three NIH SBIR Phase I grants and one SBIR Phase II grant.  The data on one of the NIH SBIR Phase I grants was the basis for the submission, and subsequent award, of the NIH SBIR Phase II grant awarded to us in the approximate amount of $850,000 in August 2008.  This NIH SBIR Phase II grant was for work in the area of using PCT to extract protein biomarkers, sub-cellular molecular complexes, and organelles, with the expectation that these studies might ultimately lead to the release of a new, commercially available PCT-based system, with validated protocols, end-user kits, and other consumables intended for the extraction of clinically important protein biomarkers, sub-cellular molecular complexes, and organelles from human and animal tissues.  All three of the NIH SBIR Phase I grants and the NIH SBIR Phase II grant have been completed.

In October 2011, we were awarded a contract for approximately $850,000 from the Department of Defense (“DoD”) to help fund the development of a PCT-based system to improve the processing of pathogenic organisms, specifically viruses and bacteria.  The contract funded studies until September 2013.

Extended Service Contracts
 
We offer extended service contracts on our laboratory instrumentation to all of our customers.  These service contracts allow a customer who purchases a Barocycler instrument to receive on-site scheduled preventative maintenance, on-site repair and replacement of all worn or defective component parts, and telephone support, all at no incremental cost for the life of the service contract.  We offer one-year and four-year extended service contracts to customers who purchase Barocycler instruments.

Other Applications of Pressure Cycling Technology
 
PCT is an enabling, platform technology based on a physical process that had not previously been used to control bio-molecular interactions.  During its early development, under the legacy business of Boston Biomedica, Inc., our scientists were researching and developing applications of pressure cycling technology in many areas of the life sciences, including genomic, proteomic and small molecule sample preparation.  The data generated during these early years, combined with the data generated since we began focusing on PCT operations in February 2005, form the basis of knowledge that we believe will allow us to successfully commercialize PCT both within and outside of the sample preparation market.

 
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Our research and development efforts have shown that, in addition to genomic, proteomic and small molecule sample preparation, PCT is potentially beneficial in a number of other areas of the life sciences, including pathogen inactivation, protein purification, control of chemical (particularly enzymatic) reactions, and immunodiagnostics.  Other applications in the sample preparation market include forensics and histology, as we discuss above.  Our pursuit of these markets, however, depends on a number of factors, including our success in commercializing PCT in the area of sample preparation, our judgment regarding the investment required to be successful in these areas, the value of these markets to our company, and the availability of sufficient financial resources.  Below is a brief explanation of each of these additional potential applications and a short description of why we believe PCT can be used to improve scientific studies in these areas.

Pathogen Inactivation
 
Biological products manufactured for human use, such as blood, vaccines and drugs, are put through rigorous processing protocols in an effort to minimize the potential of that product to transmit disease.  These protocols may include methods to remove infectious materials such as pre-processing testing, filtration or chromatography, or methods to inactivate infectious materials that are not captured in the removal steps such as pasteurization, irradiation and solvent detergent inactivation.  Notwithstanding current diligence in both the removal and inactivation steps, significant concern remains that some bacteria and viruses capable of transmitting infection to recipients may not be removed or inactivated with current procedures.  In addition, some removal and inactivation methods may not be useful because of cost, safety, ease-of-use or other practical concerns.  To that end, we believe that a new inactivation method is needed that can safely, rapidly and inexpensively inactivate pathogens in blood, vaccines and drugs without the need for chemical or other potentially toxic additives.  We believe we have successfully generated proof-of-concept that PCT can satisfy this need.  We believe that compared with current procedures, a process that uses PCT has the potential to increase safety and yield, lower cost and decrease the potential side effects of current methods.  We have been issued U.S., European, and Japanese patents for this PCT-dependent inactivation technology.

Protein Purification
 
Many vaccines and drugs are comprised of proteins.  These proteins need to be purified from complex mixtures as part of the manufacturing process. Current purification techniques often result in the loss of a significant amount of the protein.  Therefore, any method that could increase the amount of protein being recovered in the purification step, could subsequently lead to a reduction in cost to the manufacturer.  We believe we have successfully generated proof-of-concept that PCT can satisfy this need. We believe that compared with current purification procedures, a process that uses PCT has the potential to increase protein recovery, increase the quality of the product, and lower production costs.  We have been issued U.S. and European patents in this area.

Control of Chemical (Particularly Enzymatic) Reactions
 
Chemical reactions encompass many important interactions in nature.  Methods used to control chemical reactions could have a positive effect on the quality, speed, and overall result of the reaction.  The control and detection of chemical reactions is particularly useful in the biotechnology field for synthesizing and characterizing such molecules as nucleic acids and polypeptides.  We believe that PCT offers distinct advantages in controlling chemical reactions over current methods, since PCT can provide precise, automated control over the timing and synchronization of chemical reactions, particularly enzymatic reactions.  We have been issued U.S. and European patents in this area.

Immunodiagnostics
 
Many tests used in the clinical laboratory today are based on the formation of a complex between two proteins, such as an antigen and an antibody.  Such “immunodiagnostic” methods are used for the detection of infectious agents such as the human immunodeficiency virus (“HIV”), hepatitis viruses, West Nile virus, and others, as well as for endocrine, drug testing and cancer diagnostics.  We have generated proof-of-concept that PCT may be used to control biomolecular interactions between proteins, such as antigens and antibodies.  We believe this capability may provide a greater degree of sensitivity and quantitative accuracy in immunodiagnostic testing than that offered by methods that are available today.  We have been issued U.S. and European patents in this area.

 
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Customers
 
Our customers include researchers at academic laboratories, government agencies, biotechnology companies, pharmaceutical companies and other life science institutions in the United States. Our customers also include 11 foreign distribution partners.  Our goal is to continue our market penetration in these target groups and releasing products in our publicized product pipeline.  We also believe that there is a significant opportunity to sell and/or lease additional Barocycler instrumentation to additional laboratories at current customer institutions.

If we are successful in commercializing PCT in applications beyond our current focus area of genomic, proteomic, and small molecule sample preparation and if we are successful in our attempts to attract additional capital, our potential customer base could expand to include hospitals, reference laboratories, blood banks and transfusion centers, plasma collection centers, pharmaceutical manufacturing plants and other sites involved in each specific application.  If we are successful in forensics, our potential customers could be laboratories, military and other government agencies.  If we are successful in histology, our potential customers could be pharmaceutical companies, hospitals, and laboratories focused on drug discovery or correlation of disease states.

Competition
 
We compete with companies that have existing technologies for the extraction of nucleic acids, proteins and small molecules from cells and tissues, including methods such as mortar and pestle grinding, sonication, rotor-stator homogenization, French Press, bead beating, freezer milling, enzymatic digestion and chemical dissolution. We believe that there are a number of significant issues related to the use of these methods, including: complexity, sample containment, cross-contamination, shearing of biomolecules of interest, and limited applicability to different sample types, ease-of-use, reproducibility, and cost.  We believe that our PCT Sample Preparation System offers a number of significant advantages over these methods, including
 
  
labor reduction
●  
versatility
  
temperature control
●  
efficiency
  
precision
●  
simplicity
●  
reproducibility
●  
safety
 
To be competitive in the industry, we believe we must be able to clearly and conclusively demonstrate to potential customers that our products provide these improved performance capabilities.  We strongly believe that our PCT Sample Preparation System is a novel and enabling system for genomic, proteomic, and small molecule sample preparation.  As such, many users of current manual techniques will need to be willing to challenge their existing methods of sample preparation and invest time to evaluate a method that could change their overall workflow in the sample preparation process, prior to adopting our technology.

Further, we are aware that the cost of the PCT Sample Preparation System may be greater than the cost of many of the other techniques currently employed.  Consequently we are focusing our sales efforts on those product attributes that we believe will be most important and appealing to potential customers, namely versatility, reproducibility, quality and safety.

Manufacturing and Supply
 
BIT Group USA, formerly Source Scientific, LLC, currently provides all of the manufacturing and assembly services for our Barocycler NEP2320 and Barocycler NEP3229 instrumentation products under an informal, unwritten understanding.  We currently manufacture and assemble the Barocycler HUB440, the Shredder SG3, and the MicroTubes at our South Easton facility.  We plan to continue to utilize BIT Group USA as our primary assembler and contract manufacturer of our current, and future, Barocycler NEP 2320 and 3229 instruments.  Until we develop a broader network of manufacturers and subcontractors, obtaining alternative sources of supply or manufacturing services could involve significant delays and other costs and challenges, and may not be available to us on reasonable terms, if at all. The failure of a supplier or contract manufacturer to provide sufficient quantities, acceptable quality and timely products at an acceptable price, or an interruption of supplies from such a supplier could harm our business and prospects.

Research and Development
 
Our research and development activities are split into two functional areas, applications and engineering.

 
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1.  
Applications Research and Development: Our highly educated and trained staff has years of experience in molecular and cellular biology, virology, and proteomics. Our team of scientists focuses on the development of our PCT Sample Preparation System and further commercialization of PCT-dependent genomic, proteomic, and small molecule sample preparation methods. Dr. Alexander Lazarev, our vice president of Research & Development, meets regularly with our sales, marketing, and engineering staff to discuss market needs and trends. Our applications research and development team is responsible for the technical review of all scientific collaborations, for the support of our marketing and sales departments through the generation of internal data in a number of areas of market interest, and in the development of commercially-viable PCT-dependent products.

2.  
Engineering Research and Development: Our engineering research and development team is focused on the design and development of new and improved instrumentation and consumable products to support the commercialization of PCT. Our engineering department is led by Dr. Edmund Ting, our senior vice president of engineering. The primary focus of our engineering group is to ensure seamless production processes, perform installations and field service, and work with our application scientists to complete the development of a high throughput sample processing system for the mass spectrometry market.

Product Pipeline
 
The following instruments are in our research and development pipeline:

  
Barocycler FFPE Protein Extraction Instrument System - A PCT-based system offering the enhanced extraction of proteins from formalin-fixed, paraffin-embedded (“FFPE”) samples using a modified Barocycler instrument that combines the advantages of pressure cycling, high temperature and certain reagents.
 
  
XstreamPCT™ HPLC Digestion Module - For automated, in-line, on-demand PCT-enhanced protein digestion; the first module in PBI's PCT-based HPLC platform.
 
  
Barocycler HT Multiwell (24-384) - For high throughput, PCT-enhanced biomolecule extraction/accelerated enzymatic digestion with the capability of processing 48 - 384 samples.
 
  
Barocycler HUB880 High Pressure - The next in the line of modular, high pressure generating instruments, the Barocycler HUB880 will be capable of creating and controlling hydrostatic pressure from 35 Bar (500 psi) to approximately 7,000 Bar (100,000 psi).  The higher pressure limit of the Barocycler HUB880 will be nearly two times the upper limit of its’ sister instrument, the Barocycler HUB440. This higher limit will allow users to study the effects of pressure on substances (e.g., certain proteins) that do not react to pressures below 58,000 psi. Like the Barocycler HUB440, the Barocycler HUB880 will be computer controlled and run on software specially-written by PBI in LabVIEW. (by National Instruments Corporation). The Barocycler HUB880 will be the first portable, ready to use pressure generator for the laboratory bench that can reach pressures between 60,000 and 100,000 psi.  We believe that over the coming years, the Barocycler HUB880 will be one of the main instruments in the Company’s pressure-based instruments line.
 
Sales and Marketing
 
Our sales and marketing efforts are centered on using the independent data developed and disseminated by our collaboration partners to help drive the installed base of our PCT Sample Preparation System. The development of scientific data by our partners and our internal researchers provides our sales and marketing staff with additional tools that are essential in selling a new technology such as PCT.

Sales
 
Direct US Sales Force

Our domestic sales force currently consists of one full-time sales director and one part-time salesperson. We believe that hiring seasoned sales professionals with significant industry experience will allow us to penetrate the market more effectively than with a small, focused sales force. We may increase the number of sales professionals if our financial resources permit and if we believe that doing so will accelerate our commercialization efforts.

 
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Foreign Distributor Network

Currently, we have 11 distribution arrangements covering 22 countries in Europe, Asia and Australia.  In June 2008, we entered into a distribution agreement with Veritas Corporation (“Veritas”) of Tokyo, Japan pursuant to which we granted Veritas exclusive distribution rights to all of our products in Japan. This agreement extends through December 31, 2013. In October 2011, we entered into a distribution agreement with IUL Instruments GmbH (“IUL”) of Germany pursuant to which we granted IUL exclusive distribution rights to all of our products in Germany and Switzerland through March 31, 2014. In November 2011, we entered into a distributor agreement with Oroboros Instruments Corp. (“Oroboros”) of Austria pursuant to which we granted Oroboros non-exclusive world-wide distribution rights to the PBI Shredder SG3 System and related products through December 31, 2013.  In March and July 2012, we entered into a distribution agreement with six companies pursuant to which we granted non-exclusive distribution rights to certain PCT products in six European and Asian countries and Australia through December 2013.  In October 2012, we entered into a supply agreement with Cole Parmer Corporation pursuant to which we granted Cole Parmer non-exclusive, worldwide distribution rights to our PBI Shredder SG3 System and related consumables through December 2014.  In November 2012, we entered into a distribution agreement with UK-based Constant Systems (“CS”), pursuant to which we granted Constant Systems non-exclusive distribution rights to certain of our PCT SPS product line in 12 European and Asian countries. This Agreement terminates on May 31, 2014.  In June 2013, CS and PBI signed an expanded Distribution Agreement that made PBI the exclusive distributor of CS products throughout all of the Americas; this Agreement also terminates on May 31, 2014.  CS and PBI began discussions in January 2014 to extend both agreements for a minimum of two years.
 
Marketing and Sales
 
Our marketing and sales function is led by Dr. Nathan Lawrence, our vice president of Marketing and Sales. Dr. Lawrence oversees and directs marketing and sales activities such as trade show attendance and sponsorship, on-line advertising, website maintenance and improvement, search engine optimization, creation and dissemination of a PCT newsletter, market research initiatives, the arrangement of on-location seminars, lectures, and demonstrations of PCT capabilities, and the supervision of our two-person sales force. Dr. Lawrence is also responsible for the overall coordination of our collaboration programs, from initial set-up, research plan design, and training, service, and data analysis. Some of these responsibilities are shared with other PBI departments such as Research and Development, but marketing and sales drives the collaborative process. Dr. Lawrence is also responsible for the continued coordination and support of our foreign and domestic distribution partners.

In January and May 2012, we entered into co-marketing/selling and research and development agreements with Digilab, a provider of products for life sciences, analytical chemistry and diagnostic markets, and LEAP Technologies, a provider of automation equipment for the genomic and proteomic industries.  Under these agreements, we are co-marketing and co-selling our respective product lines worldwide, including in industry publications, at scientific meetings, on each company’s website, through common collaborator studies, at key industry trade shows, and in visits to customer sites. We are also exploring ways to co-develop new instrumentation, accessories/modules for existing instrumentation, and consumables that combine the robotics and high throughput capabilities of these companies’ products with the extraction, protein digestion, and other advantages of our PCT platform.

Intellectual Property
 
We believe that protection of our patents and other intellectual property is essential to our business. Subject to the availability of sufficient financial resources, our practice is to file patent applications to protect technology, inventions, and improvements to inventions that are important to our business development. We also rely on trade secrets, know-how, and technological innovations to develop and maintain our potential competitive position.

To date, we have been granted 14 United States and 10 foreign patents. Our issued patents expire between 2015 and 2027. Our failure to obtain and maintain adequate patent protection may adversely affect our ability to enter into, or affect the terms of, any arrangement for the marketing or sale of any of our PCT products. It may also allow our competitors to duplicate our products without our permission and without compensation.

License Agreements Relating to Pressure Cycling Technology
 
BioMolecular Assays, Inc.
 
In 1996, we acquired our initial equity interest in BioSeq, Inc., which at the time was developing our original pressure cycling technology. BioSeq, Inc. acquired its pressure cycling technology from BioMolecular Assays, Inc. under a technology transfer and patent assignment agreement. In 1998, we purchased all of the remaining outstanding capital stock of BioSeq, Inc., and at such time, the technology transfer and patent assignment agreement was amended to require us to pay BioMolecular Assays, Inc., a 5% royalty on our sales of products or services that incorporate or utilize the original pressure cycling technology that BioSeq, Inc. acquired from BioMolecular Assays, Inc. We are also required to pay BioMolecular Assays, Inc. 5% of the proceeds from any sale, transfer or license of all or any portion of the original pressure cycling technology. These payment obligations terminate in 2016. During the years ended December 31, 2013 and 2012, we incurred approximately $23,785 and $23,634, respectively, in royalty expense associated with our obligation to BioMolecular Assays, Inc.
 
 
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In connection with our acquisition of BioSeq, Inc., we licensed certain limited rights to the original pressure cycling technology back to BioMolecular Assays, Inc. This license is non-exclusive and limits the use of the original pressure cycling technology by BioMolecular Assays, Inc. solely for molecular applications in scientific research and development and in scientific plant research and development. BioMolecular Assays, Inc. is required to pay us a royalty equal to 20% of any license or other fees and royalties, but not including research support and similar payments, it receives in connection with any sale, assignment, license or other transfer of any rights granted to BioMolecular Assays, Inc. under the license. BioMolecular Assays, Inc. must pay us these royalties until the expiration of the patents held by BioSeq, Inc. in 1998, which we anticipate will be 2016. We have not received any royalty payments from BioMolecular Assays, Inc. under this license.

Battelle Memorial Institute
 
In December 2008, we entered into an exclusive patent license agreement with the Battelle Memorial Institute ("Battelle"). The licensed technology is the subject of a patent application filed by Battelle in 2008 and relates to a method and a system for improving the analysis of protein samples, including through an automated system utilizing pressure and a pre-selected agent to obtain a digested sample in a significantly shorter period of time than current methods, while maintaining the integrity of the sample throughout the preparatory process. In addition to royalty payments on net sales on “licensed products,” we are obligated to make minimum royalty payments for each year that we retain the rights outlined in the patent license agreement and we are required to have our first commercial sale of the licensed products within one year following the issuance of the patent covered by the licensed technology. The minimum annual royalty for 2012 was $10,000. Our only obligation for 2013 was a minimum royalty payment of $4,025.

Regulation
 
Many of our activities are subject to regulation by governmental authorities within the United States and similar bodies outside of the United States. The regulatory authorities may govern the collection, testing, manufacturing, safety, efficacy, labeling, storage, record keeping, transportation, approval, advertising, and promotion of our products, as well as the training of our employees.

All of our commercialization efforts to date are focused in the area of genomic, proteomic and small molecule sample preparation. We do not believe that our current Barocycler products used in sample preparation are considered “medical devices” under the United States Food, Drug and Cosmetic Act (the “FDA Act”) and we do not believe that we are subject to the law’s general control provisions that include requirements for registration, listing of devices, quality regulations, labeling and prohibitions against misbranding and adulteration. We also do not believe that we are subject to regulatory inspection and scrutiny. If, however, we are successful in commercializing PCT in applications beyond our current focus area of genomic, proteomic and small molecule sample preparation, such as protein purification, pathogen inactivation and immunodiagnostics, our products may be considered “medical devices” under the FDA Act, at which point we would be subject to the law’s general control provisions and regulation by the U.S. Food and Drug Administration (the “FDA”) that include requirements for registration listing of devices, quality regulations, labeling, and prohibitions against misbranding and adulteration. The process of obtaining approval to market these devices in the other potential applications of PCT would be costly and time consuming and could prohibit us from pursuing such markets.

We may also become subject to the European Pressure Equipment Directive, which requires certain pressure equipment meet certain quality and safety standards. We do not believe that we are currently subject to this directive because our Barocycler instruments are below the threshold documented in the text of the directive. If our interpretation were to be challenged, we could incur significant costs defending the challenge, and we could face production and selling delays, all of which could harm our business.

We self-certified that our Barocycler instrumentation was electromagnetically compatible, or “CE” compliant, which means that our Barocycler instruments meet the essential requirements of the relevant European health, safety and environmental protection legislation. In order to maintain our CE Marking, a requirement to sell equipment in many countries of the European Union, we are obligated to uphold certain safety and quality standards.

 
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Employees
 
At December 31, 2013, we had 9 full-time employees and 3 part-time employees. All employees enter into confidentiality agreements intended to protect our proprietary information. We believe that our relations with our employees are good. None of our employees are represented by a labor union. Our performance depends on our ability to attract and retain qualified professional, scientific and technical staff. The level of competition among employers for skilled personnel is high. Subject to our limited financial resources, we attempt to maintain employee benefit plans to enhance employee morale, professional commitment and work productivity and provide an incentive for employees to remain with us.

ITEM 1A    RISK FACTORS.

This Annual Report on Form 10-K contains forward-looking statements that involve risks and uncertainties, such as statements of our objectives, expectations and intentions. The cautionary statements made in this Annual Report on Form 10-K should be read as applicable to all forward-looking statements wherever they appear in this report. Our actual results could differ materially from those discussed herein. Factors that could cause or contribute to such differences include those discussed below, as well as those discussed elsewhere in this Annual Report on Form 10-K.

As of March 25, 2014, we had available cash of approximately $314,896. We require additional capital to fund our operations and cannot ensure that additional capital will be available on acceptable terms or at all.
 
We have experienced negative cash flows from operations from our pressure cycling technology business since we commenced our pressure cycling technology operations. As of March 25, 2014, we had available cash of approximately $314,896 which, based on current projections, including additional fund raising, will be sufficient to fund operations until August 2014. We need substantial additional capital to fund our operations beyond August 2014.

We have received an opinion from our independent registered public accounting firm expressing substantial doubt regarding our ability to continue as a going concern.
 
The audit report issued by our independent registered public accounting firm on our audited consolidated financial statements for the fiscal year ended December 31, 2013 contains an explanatory paragraph regarding our ability to continue as a going concern. The audit report states that our auditing firm has substantial doubt in our ability to continue as a going concern due to the risk that we may not have sufficient cash and liquid assets at December 31, 2013 to cover our operating and capital requirements for the next twelve-month period; and if sufficient cash cannot be obtained, we would have to substantially alter, or possibly even discontinue, operations. The accompanying consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Management has developed a plan to continue operations. This plan includes further reductions in expenses and obtaining equity or debt financing including our most recently completed financing on February 28, 2014  in which we sold units consisting of shares of convertible preferred stock and warrants to purchase shares of Common Stock for net proceeds of approximately $630,360.  Although we have successfully completed equity financings and reduced expenses in the past, we cannot assure you that our plans to address these matters in the future will be successful.

The factors described above could adversely affect our ability to obtain additional financing on favorable terms, if at all, and may cause investors to have reservations about our long-term prospects, and may adversely affect our relationships with customers. There can be no assurance that our auditing firm will not qualify its opinion in the future. If we cannot successfully continue as a going concern, our stockholders may lose their entire investment in us.

Our business could be adversely affected if we fail to implement and maintain effective disclosure controls and procedures and internal control over financial reporting  
 
We concluded that as of December 31, 2013, our disclosure controls and procedures and our internal control over financial reporting were not effective.  As described in Item 9A of this Annual Report on Form 10-K, we have determined that we have limited resources for adequate personnel to prepare and file reports under the Securities Exchange Act of 1934 within the required time periods and that material weaknesses in our internal control over financial reporting exist relating to our accounting for complex equity transactions.  If we are unable to implement and maintain effective disclosure controls and procedures and remediate the material weaknesses in a timely manner, or if we identify other material weaknesses in the future, our ability to produce accurate and timely financial statements and public reports could be impaired, which could adversely affect our business and financial condition. We identified a lack of sufficient segregation of duties.  Specifically, this material weakness is such that the design over these areas relies primarily on detective controls and could be strengthened by adding preventive controls to properly safeguard assets.   In addition, investors may lose confidence in our reported information and the market price of our Common Stock may decline.
 
 
17

 
 
We will need a greater amount of additional capital than we currently expect to need if we experience unforeseen costs or expenses, unanticipated liabilities or delays in implementing our business plan, developing our products and achieving commercial sales.
 
We need substantial capital to implement our sales distribution strategy for our current products and to develop and commercialize future products using our pressure cycling technology products and services in the sample preparation area, as well as for applications in other areas of life sciences. Our capital requirements will depend on many factors, including but not limited to:

  
the problems, delays, expenses, and complications frequently encountered by early-stage companies;
  
market acceptance of our pressure cycling technology products and services for sample preparation;
  
the success of our sales and marketing programs; and
  
changes in economic, regulatory or competitive conditions in the markets we intend to serve.

To satisfy our potential capital requirements to cover the cost of implementing our sales distribution strategy for our current products and services and to develop and commercialize future products and services using our pressure cycling technology relating to sample preparation and other life science applications, we need to raise additional funds in the public or private capital markets. We may seek to raise any necessary additional funds through the issuance of warrants, equity or debt financings or executing collaborative arrangements with corporate partners or other sources, which may be dilutive to existing stockholders or otherwise have a material effect on our current or future business prospects. Additional financing may not be available to us on a timely basis, if at all, or on terms acceptable to us. If adequate funds are not available or if we fail to obtain acceptable additional financing, we may be required to:

  
severely limit or cease our operations or otherwise reduce planned expenditures and forego other   business opportunities, which could harm our business;
  
obtain financing with terms that may have the effect of substantially diluting or adversely affecting the holdings or the rights of the holders of our capital stock; or
  
obtain funds through arrangements with future collaboration partners or others that may require us to relinquish rights to some or all of our technologies or products.

Our actual results and performance, including our ability to raise additional capital, may be adversely affected by current economic conditions.
 
Our actual results and performance could be adversely affected by the current economic conditions in the global economy, which continue to pose a risk to the overall demand for our products from our customers who may elect to defer or cancel purchases of, or decide not to purchase, our products in response to continuing tightness in the credit markets, negative financial news and general uncertainty in the economy. In addition, our ability to obtain additional financing, on acceptable terms, if at all, may be adversely affected by the uncertainty in the current economic climate.

We have a history of operating losses, anticipate future losses and may never be profitable.
 
We have experienced significant operating losses in each period since we began investing resources in PCT and CP. These losses have resulted principally from research and development, sales and marketing, and general and administrative expenses associated with the development of our PCT business. During the year ended December 31, 2013, we recorded a net loss applicable to common shareholders of $5,247,450, or ($0.44) per share, as compared with $4,400,215, or ($0.43) per share, of the corresponding period in 2012. We expect to continue to incur operating losses until sales of our PCT and CP products increase substantially. We cannot be certain when, if ever, we will become profitable. Even if we were to become profitable, we might not be able to sustain such profitability on a quarterly or annual basis.
 
 
18

 
 
Our financial results depend on revenues from our pressure cycling technology products and services, and from government grants.
 
We currently rely on revenues from our PCT and CP technology products and services in the sample preparation area and from revenues derived from grants awarded to us by governmental agencies, such as the National Institutes of Health. We have been unable to achieve market acceptance of our product offerings to the extent necessary to achieve significant revenue. Competition for government grants is very intense, and we can provide no assurance that we will continue to be awarded grants in the future. If we are unable to increase revenues from sales of our pressure cycling technology products and services and government grants, our business will fail.

We may be unable to obtain market acceptance of our pressure cycling technology products and services.
 
Many of our initial sales of our pressure cycling technology products and services have been to our collaborators, following their use of our products in studies undertaken in sample preparation for genomics, proteomics and small molecules studies. Later sales have been to key opinion leaders.  Our technology requires scientists and researchers to adopt a method of sample extraction that is different than existing techniques. Our PCT sample preparation system is also more costly than existing techniques. Our ability to obtain market acceptance will depend, in part, on our ability to demonstrate to our potential customers that the benefits and advantages of our technology outweigh the increased cost of our technology compared with existing methods of sample extraction. If we are unable to demonstrate the benefits and advantages of our products and technology as compared with existing technologies, we will not gain market acceptance and our business will fail.

Our business may be harmed if we encounter problems, delays, expenses, and complications that often affect companies that have not achieved significant market acceptance.
 
Our pressure cycling technology business continues to face challenges in achieving market acceptance. If we encounter problems, delays, expenses and complications, many of which may be beyond our control or may harm our business or prospects. These include:

  
 availability of adequate financing;
  
 unanticipated problems and costs relating to the development, testing, production, marketing, and sale of our products;
  
 delays and costs associated with our ability to attract and retain key personnel; and
  
competition.

The sales cycle of our pressure cycling technology products is lengthy. We have incurred and may continue to incur significant expenses and we may not generate any significant revenue related to those products.
 
Many of our current and potential customers have required between three and six months or more to test and evaluate our pressure cycling technology products. This increases the possibility that a customer may decide to cancel its order or otherwise change its plans, which could reduce or eliminate our sales to that potential customer. As a result of this lengthy sales cycle, we have incurred and may continue to incur significant research and development, selling and marketing, and general and administrative expense related to customers from whom we have not yet generated any revenue from our products, and from whom we may never generate the anticipated revenue if a customer is not satisfied with the results of the evaluation of our products or if a customer cancels or changes its plans.

Our business could be harmed if our products contain undetected errors or defects.
 
We are continuously developing new and improving our existing, pressure cycling technology products in sample preparation and we expect to do so in other areas of life sciences depending upon the availability of our resources. Newly introduced products can contain undetected errors or defects. In addition, these products may not meet their performance specifications under all conditions or for all applications. If, despite internal testing and testing by our collaborators, any of our products contain errors or defects or fail to meet customer specifications, then we may be required to enhance or improve those products or technologies. We may not be able to do so on a timely basis, if at all, and may only be able to do so at considerable expense. In addition, any significant reliability problems could result in adverse customer reaction, negative publicity or legal claims and could harm our business and prospects.

        Our success may depend on our ability to manage growth effectively.
 
Our failure to manage growth effectively could harm our business and prospects. Given our limited resources and personnel, growth of our business could place significant strain on our management, information technology systems, sources of manufacturing capacity and other resources. To properly manage our growth, we may need to hire additional employees and identify new sources of manufacturing capabilities. Failure to effectively manage our growth could make it difficult to manufacture our products and fill orders, as well as lead to declines in product quality or increased costs, any of which would adversely impact our business and results of operations.
 
 
19

 
 
Our success is substantially dependent on the continued service of our senior management.
 
Our success is substantially dependent on the continued service of our senior management. We do not have long-term employment agreements with our key employees. The loss of the services of any of our senior management has made, and could make it more difficult to successfully operate our business and achieve our business goals. In addition, our failure to retain existing engineering, research and development and sales personnel could harm our product development capabilities and customer and employee relationships, delay the growth of sales of our products and could result in the loss of key information, expertise or know-how.

We may not be able to hire or retain the number of qualified personnel, particularly engineering and sales personnel, required for our business, which would harm the development and sales of our products and limit our ability to grow.
 
Competition in our industry for senior management, technical, sales, marketing, finance and other key personnel is intense. If we are unable to retain our existing personnel, or attract and train additional qualified personnel, either because of competition in our industry for such personnel or because of insufficient financial resources, our growth may be limited. Our success also depends in particular on our ability to identify, hire, train and retain qualified engineering and sales personnel with experience in design, development and sales of laboratory equipment.

Our reliance on a single third party for all of our manufacturing, and certain of our engineering, and other related services could harm our business.
 
We currently rely on BIT Group USA (“BIT Group”), a third party contract manufacturer, to manufacture our PCT instrumentation, provide engineering expertise, and manage the majority of our sub-contractor supplier relationships. Because of our dependence on one manufacturer, our success will depend, in part, on the ability of BIT Group to manufacture our products cost effectively, in sufficient quantities to meet our customer demand, if and when such demand occurs, and meeting our quality requirements. If BIT Group experiences manufacturing problems or delays, or if BIT Group decides not to continue to provide us with these services, our business may be harmed. While we believe other contract manufacturers are available to address our manufacturing and engineering needs, if we find it necessary to replace BIT Group, there will be a disruption in our business and we would incur additional costs and delays that would harm our business.

Our failure to manage current or future alliances or joint ventures effectively may harm our business.
 
We have entered into business relationships with 11 distribution partners and one co-marketing partner, and we may enter into additional alliances, joint ventures or other business relationships to further develop, market and sell our pressure cycling technology product line. We may not be able to:

  
identify appropriate candidates for alliances, joint ventures or other business relationships;
  
assure that any candidate for an alliance, joint venture or business relationship will provide us with the support anticipated;
  
successfully negotiate an alliance, joint venture or business relationship on terms that are advantageous to us; or
  
successfully manage any alliance or joint venture.

Furthermore, any alliance, joint venture or other business relationship may divert management time and resources. Entering into a disadvantageous alliance, joint venture or business relationship, failing to manage an alliance, joint venture or business relationship effectively, or failing to comply with any obligations in connection therewith, could harm our business and prospects.

We may not be successful in growing our international sales.
 
We cannot guarantee that we will successfully develop our international sales channels to enable us to generate significant revenue from international sales. We currently have 11 international distribution agreements that cover 22 countries in Europe, Asia and Australia. We have generated limited sales to date from international sales and cannot guarantee that we will be able to increase our sales. As we expand, our international operations may be subject to numerous risks and challenges, including:

  
multiple, conflicting and changing governmental laws and regulations, including those that regulate high pressure equipment;
  
reduced protection for intellectual property rights in some countries;
  
protectionist laws and business practices that favor local companies;
  
political and economic changes and disruptions;
  
export and import controls;
  
tariff regulations; and
  
currency fluctuations.
 
 
20

 
 
Our operating results are subject to quarterly variation. Our operating results may fluctuate significantly from period to period depending on a variety of factors, including but not limited to the following:
 
  
our ability to increase our sales of our pressure cycling technology products for sample preparation on a consistent quarterly or annual basis;
  
the lengthy sales cycle for our products;
  
the product mix of the Barocycler instruments we install in a given period, and whether the installations are completed pursuant to sales, rental or lease arrangements, and the average selling prices that we are able to command for our products;
  
our ability to manage our costs and expenses;
  
our ability to continue our research and development activities without incurring unexpected costs and expenses; and
  
our ability to comply with state and federal regulations without incurring unexpected costs and expenses.

Our instrumentation operates at high pressures and may therefore become subject to certain regulation in the European Community. Regulation of high pressure equipment may limit or hinder our development and sale of future instrumentation.
 
Our Barocycler instruments operate at high pressures. If our Barocycler instruments exceed certain pressure levels, our products may become subject to the European Pressure Equipment Directive, which requires certain pressure equipment meet certain quality and safety standards. We do not believe that we are subject to this directive because our Barocycler instruments are currently below the threshold documented in the text of the directive. If our interpretation were to be challenged, we could incur significant costs defending the challenge, and we could face production and selling delays, all of which could harm our business.

We expect that we will be subject to regulation in the United States, such as the Food and Drug Administration, and overseas, if and when we begin to invest more resources in the development and commercialization of PCT in applications outside of sample preparation for the research field.
 
Our current pressure cycling technology products in the area of sample preparation for the research field are not regulated by the FDA. Applications in which we intend to develop and commercialize pressure cycling technology, such as protein purification, pathogen inactivation and immunodiagnostics, are expected to require regulatory approvals or clearances from regulatory agencies, such as the FDA, prior to commercialization, when we expand our commercialization activities outside of the research field. We expect that obtaining these approvals or clearances will require a significant investment of time and capital resources and there can be no assurance that such investments will receive approvals or clearances that would allow us to commercialize the technology for these applications.

If we are unable to protect our patents and other proprietary technology relating to our pressure cycling technology products, our business will be harmed.
 
Our ability to further develop and successfully commercialize our products will depend, in part, on our ability to enforce our patents, preserve our trade secrets, and operate without infringing the proprietary rights of third parties. We currently have 14 United States and 10 foreign patents. The patents expire between 2015 and 2027.

There can be no assurance that (a) any patent applications filed by us will result in issued patents; (b) patent protection will be secured for any particular technology; (c) any patents that have been or may be issued to us will be valid or enforceable; (d) any patents will provide meaningful protection to us; (e) others will not be able to design around our patents; and (f) our patents will provide a competitive advantage or have commercial value. The failure to obtain adequate patent protection would have a material adverse effect on us and may adversely affect our ability to enter into, or affect the terms of, any arrangement for the marketing or sale of any product.

Our patents may be challenged by others.
 
We could incur substantial costs in patent proceedings, including interference proceedings before the United States Patent and Trademark Office, and comparable proceedings before similar agencies in other countries, in connection with any claims that may arise in the future. These proceedings could result in adverse decisions about the patentability of our inventions and products, as well as about the enforceability, validity, or scope of protection afforded by the patents.
 
 
21

 
 
If we are unable to maintain the confidentiality of our trade secrets and proprietary knowledge, others may develop technology and products that could prevent the successful commercialization of our products.
 
We rely on trade secrets and other unpatented proprietary information in our product development activities. To the extent we rely on trade secrets and unpatented know-how to maintain our competitive technological position, there can be no assurance that others may not independently develop the same or similar technologies. We seek to protect our trade secrets and proprietary knowledge, in part, through confidentiality agreements with our employees, consultants, advisors and contractors. These agreements may not be sufficient to effectively prevent disclosure of our confidential information and may not provide us with an adequate remedy in the event of unauthorized disclosure of such information. If our employees, consultants, advisors, or contractors develop inventions or processes independently that may be applicable to our products, disputes may arise about ownership of proprietary rights to those inventions and processes. Such inventions and processes will not necessarily become our property, but may remain the property of those persons or their employers. Protracted and costly litigation could be necessary to enforce and determine the scope of our proprietary rights. Failure to obtain or maintain trade secret protection, for any reason, could harm our business.

If we infringe on the intellectual property rights of others, our business may be harmed.
 
It is possible that the manufacture, use or sale of our pressure cycling technology products or services may infringe patent or other intellectual property rights of others. We may be unable to avoid infringement of the patent or other intellectual property rights of others and may be required to seek a license, defend an infringement action, or challenge the validity of the patents or other intellectual property rights in court. We may be unable to secure a license on terms and conditions acceptable to us, if at all. Also, we may not prevail in any patent or other intellectual property rights litigation. Patent or other intellectual property rights litigation is costly and time-consuming, and there can be no assurance that we will have sufficient resources to bring any possible litigation related to such infringement to a successful conclusion. If we do not obtain a license under such patents or other intellectual property rights, or if we are found liable for infringement, or if we are unsuccessful in having such patents declared invalid, we may be liable for significant monetary damages, may encounter significant delays in successfully commercializing and developing our pressure cycling technology products, or may be precluded from participating in the manufacture, use, or sale of our pressure cycling technology products or services requiring such licenses.

We may be unable to adequately respond to rapid changes in technology and the development of new industry standards.
 
The introduction of products and services embodying new technology and the emergence of new industry standards may render our existing pressure cycling technology products and related services obsolete and unmarketable if we are unable to adapt to change. We may be unable to allocate the funds necessary to improve our current products or introduce new products to address our customers’ needs and respond to technological change. In the event that other companies develop more technologically advanced products, our competitive position relative to such companies would be harmed.

We may not be able to compete successfully with others that are developing or have developed competitive technologies and products.
 
A number of companies have developed, or are expected to develop, products that compete or will compete with our products. We compete with companies that have existing technologies for the extraction of nucleic acids, proteins and small molecules from cells and tissues, including methods such as mortar and pestle, sonication, rotor-stator homogenization, French press, bead beating, freezer milling, enzymatic digestion, and chemical dissolution.

We are aware that there are additional companies pursuing new technologies with similar goals to the products developed or being developed by us. Some of the companies with which we now compete, or may compete in the future, have or may have more extensive research, marketing, and manufacturing capabilities, more experience in genomics and proteomics sample preparation, protein purification, pathogen inactivation, immunodiagnostics, and DNA sequencing and significantly greater technical, personnel and financial resources than we do, and may be better positioned to continue to improve their technology to compete in an evolving industry. To compete, we must be able to demonstrate to potential customers that our products provide improved performance and capabilities. Our failure to compete successfully could harm our business and prospects.
 
 
22

 
 
Provisions in our articles of organization and bylaws may discourage or frustrate stockholders’ attempts to remove or replace our current management.
 
Our articles of organization and bylaws contain provisions that may make it more difficult or discourage changes in our management that our stockholders may consider to be favorable. These provisions include:

  
a classified board of directors;
  
advance notice for stockholder nominations to the board of directors;
  
limitations on the ability of stockholders to remove directors; and
  
a provision that allows a majority of the directors to fill vacancies on the board of directors.

These provisions could prevent or frustrate attempts to make changes in our management that our stockholders consider to be beneficial and could limit the price that our stockholders might receive in the future for shares of our   Common Stock.

The costs of compliance with the reporting obligations of the Exchange Act, and with the requirements of the Sarbanes-Oxley Act of 2002 and the Dodd-Frank Wall Street Reform and Consumer Protection Act, may place a strain on our limited resources and our management’s attention may be diverted from other business concerns.
 
As a result of the regulatory requirements applicable to public companies, we incur legal, accounting, and other expenses that are significant in relation to the size of our company. In addition, the Sarbanes-Oxley Act of 2002 and the Dodd-Frank Wall Street Reform and Consumer Protection Act, as well as rules subsequently implemented by the SEC and OTC Markets Group, Inc., have required changes in corporate governance and financial disclosure practices of public companies, some of which are currently applicable to us and others will or may become applicable to us in the future. These rules and regulations have increased and will continue to increase our legal and financial compliance costs and may make some activities more time-consuming. These requirements have placed and will continue to place a strain on our systems and on our management and financial resources.

Certain of our net deferred tax assets could be substantially limited if we experience an ownership change as defined in the Internal Revenue Code.
 
Certain of our net operating losses (“NOLs”) give rise to net deferred tax assets. Our ability to utilize NOLs and to offset our future taxable income and/or to recover previously paid taxes would be limited if we were to undergo an “ownership change” within the meaning of Section 382 of the Internal Revenue Code (the “Code”).  In general, an “ownership change” occurs whenever the percentage of the stock of a corporation owned by “5 percent shareholders,” within the meaning of Section 382 of the Code, increases by more than 50 percentage points over the lowest percentage of the stock of such corporation owned by such “5 percent shareholders” at any time over the preceding three years.

An ownership change under Section 382 of the Code would establish an annual limitation on the amount of NOLs we could utilize to offset our taxable income in any single taxable year to an amount equal to (i) the product of a specified rate, which is published by the U.S. Treasury, and the aggregate value of our outstanding stock plus; and (ii) the amount of unutilized limitation from prior years. The application of these limitations might prevent full utilization of the deferred tax assets attributable to our NOLs. We may have or will have experienced an ownership change as defined by Section 382 through the sale of equity and, therefore, we will consider whether the sale of equity units will result in limitations of our net operating losses under Section 382 when we start to generate taxable income. However, whether a change in ownership occurs in the future is largely outside of our control, and there can be no assurance that such a change will not occur.

Risks Related to Share Ownership:
 
The holders of our Common Stock could suffer substantial dilution due to our corporate financing practices.
 
      The holders of our Common Stock could suffer substantial dilution due to our corporate financing practices, which, in the past few years, have included private placements and a registered direct offering. As of December 31, 2013, we have issued shares of Series A Convertible Preferred Stock, Series B Convertible Preferred Stock, Series C Convertible Preferred Stock, Series D Convertible Preferred Stock, Series E Convertible Preferred Stock, Series G Convertible Preferred Stock, Series H Convertible Preferred Stock, Series J Convertible Preferred Stock and Series K Convertible Preferred Stock.
 
As of December 31, 2013, all of the shares of Series A Convertible Preferred Stock, Series B Convertible Preferred Stock, Series C Convertible Preferred Stock, and Series E Convertible Preferred Stock had been converted into shares of Common Stock.  As of December 31, 2013 only shares of Series D Convertible Preferred Stock, Series G Convertible Preferred Stock, Series H Convertible Preferred Stock, Series J Convertible Preferred Stock and Series K Convertible Preferred Stock were outstanding.  Further, in connection with those private placements and the Series D registered direct offering, we issued warrants to purchase Common Stock. In addition, as of December 31, 2013, the company has issued notes convertible into common stock at prices ranging from $0.14 to $0.40 per common share.  If all of the outstanding shares of Series D Convertible Preferred Stock, Series G Convertible Preferred Stock, Series H Convertible Preferred Stock, Series J Convertible Preferred Stock and Series K Convertible Preferred Stock were converted into shares of Common Stock and all outstanding warrants to purchase shares of Common Stock were exercised and all notes were converted, each as of March 31, 2014, an additional 40,396,735 shares of Common Stock would be issued and outstanding.  This additional issuance of shares of Common Stock would cause immediate and substantial dilution to our existing stockholders and could cause a significant reduction in the market price of our Common Stock.
 
 
23

 
 
Sales of a significant number of shares of our Common Stock in the public market or the perception of such possible sales, could depress the market price of our Common Stock.
 
Sales of a substantial number of shares of our Common Stock in the public markets, which include an offering of our preferred stock or Common Stock could depress the market price of our Common Stock and impair our ability to raise capital through the sale of additional equity or equity-related securities. We cannot predict the effect that future sales of our Common Stock or other equity-related securities would have on the market price of our Common Stock.

Our share price could be volatile and our trading volume may fluctuate substantially.
 
The price of Common Stock has been and may in the future continue to be extremely volatile, with the sale price fluctuating from a low of $0.15 to a high of $0.97 since January 1, 2012. Many factors could have a significant impact on the future price of our shares of Common Stock, including:

  
our inability to raise additional capital to fund our operations, whether through the issuance of equity securities or debt;
  
our failure to successfully implement our business objectives;
  
compliance with ongoing regulatory requirements;
  
market acceptance of our products;
  
technological innovations and new commercial products by our competitors;
  
changes in government regulations;
  
general economic conditions and other external factors;
  
actual or anticipated fluctuations in our quarterly financial and operating results; and
  
the degree of trading liquidity in our shares of  Common Stock.

A decline in the price of our shares of Common Stock could affect our ability to raise further working capital
 and adversely impact our ability to continue operations.

The relatively low price of our shares of Common Stock, and a decline in the price of our shares of Common Stock, could result in a reduction in the liquidity of our Common Stock and a reduction in our ability to raise capital. Because a significant portion of our operations has been and will continue to be financed through the sale of equity securities, a decline in the price of our shares of Common Stock could be especially detrimental to our liquidity and our operations. Such reductions and declines may force us to reallocate funds from other planned uses and may have a significant negative effect on our business plans and operations, including our ability to continue our current operations. If the price for our shares of Common Stock declines, it may be more difficult to raise additional capital. If we are unable to raise sufficient capital, and we are unable to generate funds from operations sufficient to meet our obligations, we will not have the resources to continue our operations.

The market price for our shares of Common Stock may also be affected by our ability to meet or exceed expectations of analysts or investors. Any failure to meet these expectations, even if minor, may have a material adverse effect on the market price of our shares of Common Stock.

If we issue additional securities in the future, it will likely result in the dilution of our shares of existing stockholders.
 
    Our restated articles of organization, as amended, currently authorize the issuance of up to 50,000,000 shares of Common Stock and 1,000,000 shares of preferred stock. As of March 31, 2014, we had 12,624,267 shares of Common Stock issued and outstanding; 300 units of Series D issued and outstanding (convertible into 750,000 shares of Common Stock); 145,320 shares of Series G Convertible Preferred Stock (convertible into 1,453,200 shares of Common Stock); 5,087.5 shares of Series J Convertible Preferred Stock (convertible into 5,087,500 shares of Common Stock), 10,000 shares of Series H Convertible Preferred Stock (convertible into 1,000,000 shares of Common Stock) 10,729 shares of Series K Convertible Preferred Stock (convertible into 19,019,700 shares of Common Stock); outstanding options and warrants to purchase an aggregate of 19,994,535 shares of Common Stock; and convertible debt convertible into 932,500 shares of Common Stock. In September 2012 we increased the number of our authorized shares of Common Stock from 20,000,000 to 50,000,000. From time to time, we also may increase the number of shares available for issuance in connection with our equity compensation plan, we may adopt new equity compensation plans, and we may issue awards to our employees and others who provide services to us outside the terms of our equity compensation plans. Our board of directors may fix and determine the designations, rights, preferences or other variations of each class or series of preferred stock and may choose to issue some or all of such shares to provide additional financing in the future.
 
 
24

 
 
The issuance of any securities for acquisition, licensing or financing efforts, upon conversion of any preferred stock or exercise of warrants, pursuant to our equity compensation plans, or otherwise may result in a reduction of the book value and market price of the outstanding shares of our Common Stock. If we issue any such additional securities, such issuance will cause a reduction in the proportionate ownership and voting power of all current stockholders. Further, such issuance may result in a change in control of our Company.

Financial Industry Regulatory Authority (“FINRA”) sales practice requirements may also limit a stockholder’s ability to buy and sell our Common Stock.
 
FINRA has adopted rules that require that in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer. Prior to recommending speculative low-priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information. Under interpretations of these rules, FINRA believes that there is a high probability that speculative low-priced securities will not be suitable for at least some customers. FINRA requirements make it more difficult for broker-dealers to recommend that their customers buy our Common Stock, which may limit your ability to buy and sell our Common Stock and have an adverse effect on the market for our shares.

We have never paid dividends on our Common Stock and do not anticipate paying any in the foreseeable future.
 
We have never declared or paid a cash dividend on our Common Stock and we do not expect to pay cash dividends on our Common Stock in the foreseeable future.
 
Our shares of Series D Convertible Preferred Stock are entitled to certain rights, privileges and preferences over our  Common Stock, including a preference upon a liquidation of our company, which will reduce amounts available for distribution to the holders of our  Common Stock.
 
The holders of our shares of Series D are entitled to payment, prior to payment to the holders of Common Stock in the event of liquidation of the Company.

 
25

 
 
ITEM 1B.    UNRESOLVED STAFF COMMENTS.
 
Not Applicable.
 
ITEM 2.    PROPERTIES.

Our corporate office is currently located at 14 Norfolk Avenue, South Easton, Massachusetts 02375. We are currently paying $4,800 per month, on a lease extension, signed on December 31, 2013, that expires December 31, 2014, for our corporate office.

Effective January 1, 2010, we entered into a three-year lease agreement with the University of Massachusetts in Boston, pursuant to which we are leasing laboratory and office space at the Venture Development Center on campus at the university for research and development activities. In September 2012, we extended the lease to the end of December 31, 2014 at $5,500 per month for the use of these facilities at the University of Massachusetts. We believe that our facilities are adequate for our operations and that suitable additional space will be available if and when needed.

ITEM 3.    LEGAL PROCEEDINGS.

We are not currently involved in any litigation that we believe could have a material adverse effect on our financial condition or results of operations. There is no action, suit, or proceeding by any court, public board, government agency, self-regulatory organization or body pending or, to the knowledge of the executive officers of our company or our subsidiary, threatened against or affecting our company, our common stock, our subsidiary or of our companies or our subsidiary’s officers or directors in their capacities as such, in which an adverse decision could have a material adverse effect.

ITEM 4.    MINE SAFETY DISCLOSURES.

Not applicable.
 
[INTENTIONALLY LEFT BLANK]
 
 
 
 
 
 
 
26

 
 
PART II

ITEM 5.   MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITY SECURITIES.

Our Common Stock is currently traded on the OTCQB tier of the OTC Markets under the trading symbol “PBIO.” As previously reported, the NASDAQ Hearings Panel determined to delist the Company’s Common Stock from the NASDAQ Stock Market and trading in the Company’s Common Stock on the NASDAQ Stock Market was discontinued effective at the open of trading on April 5, 2012.  Effective April 5, 2012, the Company’s Common Stock began trading on the OTCQB tier of OTC Markets.

The following table sets forth, for the periods indicated, the high and low sales price and the high and low bids, as applicable, per share of Common Stock, as reported by the OTC Markets from January 1, 2012 through December 31, 2013.

   
Year Ended December 31, 2013
 
   
High
   
Low
 
First Quarter
  $ 0.51     $ 0.20  
Second Quarter
  $ 0.42     $ 0.23  
Third Quarter
  $ 0.33     $ 0.20  
Fourth Quarter
  $ 0.29     $ 0.16  
 
   
Year Ended December 31, 2012
 
   
High
   
Low
 
First Quarter
  $ 0.97     $ 0.50  
Second Quarter
  $ 0.75     $ 0.20  
Third Quarter
  $ 0.63     $ 0.21  
Fourth Quarter
  $ 0.44     $ 0.15  

Authorized Capital
 
As of December 31, 2013, we were authorized to issue 50,000,000 shares of Common Stock, $.01 par value, and 1,000,000 shares of preferred stock, $.01 par value. Of the 1,000,000 shares of preferred stock, 20,000 shares were designated as Series A Junior Participating Preferred Stock, 313,960 shares as Series A Convertible Preferred Stock, 279,256 shares as Series B Convertible Preferred Stock, 88,098 shares as Series C Convertible Preferred Stock, 850 shares as Series D Convertible Preferred Stock, 500 shares as Series E Convertible Preferred Stock, 240,000 shares as Series G Convertible Preferred Stock, 10,000 shares as Series H Convertible Preferred Stock, 6,250 shares as Series J Convertible Preferred Stock and 15,000 shares as Series K Convertible Preferred Stock.

As of December 31, 2013, there were 12,024,267 shares of Common Stock issued and outstanding. Similarly, at such time, there were no shares of Series A Junior Participating Preferred Stock; Series A Convertible Preferred Stock; Series B Convertible Preferred Stock; Series C Convertible Preferred Stock; Series E Convertible Preferred Stock.  As of December 31, 2013 there were 300 shares of Series D Convertible Preferred Stock issued and outstanding and convertible into 750,000 shares of Common Stock,  145,320 shares of Series G Convertible Preferred Stock issued and outstanding convertible into 1,453,200 shares of Common Stock, 10,000 shares of Series H Convertible Preferred Stock issued and outstanding convertible into 1,000,000 shares of Common Stock, 5,087.5 shares of Series J Convertible Preferred Stock issued and outstanding convertible into 5,087,500 shares of Common Stock, and 4,000 shares of Series K Convertible Preferred Stock issued and outstanding convertible into 4,000,000 shares of Common Stock.

Approximate Number of Equity Security Holders

     As of December 31, 2013, there were approximately 201 stockholders of record. Because shares of our common stock are held by depositaries, brokers and other nominees, the number of beneficial holders of our shares is substantially larger than the number of stockholders of record.
 
 
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Dividends
 
We have never declared or paid any cash dividends on Common Stock and do not plan to pay any cash dividends on Common Stock in the foreseeable future. The shares of Series D are entitled to payment prior to payment to the holders of Common Stock in the event of liquidation of the Company.

The Holder of our Series E Preferred Stock was entitled to a yearly dividend at a rate of 10.5% per year, subject to a credit risk and make-whole adjustment, and was payable in cash or shares of Common Stock at our election. Under certain conditions and subject to certain limitations, we could have required the Holder to convert their Series E Convertible Preferred Stock into Common Stock.  The make-whole dividends were payable any time after the closing on April 9, 2012 at the option of the Holder; therefore, we recognized the full value of $262,500 as a current liability and charged this amount immediately to accumulated deficit. The Holder converted all 500 shares of Series E Preferred Stock in 2012.

As of December 31, 2013, dividends issued or to be issued for the years ended December 31, 2013 and 2012 are outlined in the table below.

 
Common shares issued
   
Common shares to be issued
 
For The Year Ended December 31,
   
For The Year Ended December 31,
   
2013
 
2012
     
2013
 
2012
Series A
 
-
 
-
 
Series A
 
 -
 
 -
Series B
 
-
 
96,966
 
Series B
 
 -
 
 -
Series C
 
-
 
64,621
 
Series C
 
 -
 
 -
Series D
 
-
 
-
 
Series D
 
-
 
-
Series E
 
-
 
622,837
 
Series E
 
-
 
-
Series G
 
-
 
-
 
Series G
 
-
 
-
Series H
 
-
 
-
 
Series H
 
-
 
-
Series J
 
-
 
-
 
Series J
 
-
 
-
Series K
 
-
 
-
 
Series K
 
-
 
-
   
-
 
784,424
     
-
 
-
 
    Dividends paid in  Common Stock or cash    
Dividends payable
   
For The Year Ended December 31,
   
For The Year Ended December 31,
   
2013
 
2012
     
2013
 
2012
Series A
 
$-
 
$-
 
Series A
 
 $-
 
 $-
Series B
 
-
 
69,647
 
Series B
 
-
 
-
Series C
 
-
 
10,609
 
Series C
 
-
 
-
Series D
 
             -
 
             -
 
Series D
 
-
 
-
Series E
 
60,000
 
359,430
 
Series E
 
-
 
60,000
Series G
 
-
 
-
 
Series G
 
89,527
 
-
Series H
 
-
 
-
 
Series H
 
-
 
-
Series J
 
-
 
-
 
Series J
 
95,341
 
-
Series K
 
-
 
-
 
Series K
 
3,131
 
27,584
   
 $60,000
 
 $439,686
     
 $187,999
 
 $87,584
 
Recent Sales of Unregistered Securities

On January 29 and February 28, 2014, the Company entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with various individuals (each, a “Purchaser”), pursuant to which the Company sold an aggregate of 4,875 units for a purchase price of $250.00 per unit (the “Purchase Price”), or an aggregate Purchase Price of $1,218,750 and 1,854 units for a Purchase Price of $340.00 per unit or an aggregate Purchase Price of $630,360 respectively.  This represents the second and third tranches of a $1.5 million private placement (the “Private Placement”).  One or more additional tranches in the Private Placement may close on or before April 4, 2014.  Each unit purchased in the first three tranches (“Unit”) consists of (i) one share of a newly created series of preferred stock, designated Convertible Preferred Stock, par value $0.01 per share (the “Series K Convertible Preferred Stock”), convertible into 1,000 shares of the Company’s Common Stock, par value $0.01 per share (“Common Stock”) and (ii) a warrant to purchase 500 shares of Common Stock at an exercise price equal to $0.3125, for the second tranche and $0.425 for the third tranche, per share, with a term expiring three years from the respective closing date  (“Warrant”).  Of the $2,849,110 invested in the first three tranches of the Private Placement, $2,028,404 was received in cash and $820,706 was from the conversion of outstanding indebtedness and accrued board of directors’ fees.  The Purchasers in the first three tranches of the Private Placement consisted of certain existing and new investors in the Company as well as all of the members of the Company’s Board of Directors.

 
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Repurchases by Pressure BioSciences, Inc.
 
During 2013, the Company exchanged 1,000,000 shares of Common Stock held by an investor for 10,000 shares of Series H Convertible Preferred stock.
 
ITEM 6.    SELECTED FINANCIAL DATA.

Not Applicable.
 
ITEM 7.   MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION.

OVERVIEW
 
We are focused on solving the challenging problems inherent in biological sample preparation, a crucial laboratory step performed by scientists worldwide working in biological life sciences research. Sample preparation is a term that refers to a wide range of activities that precede most forms of scientific analysis. Sample preparation is often complex, time-consuming, and in our belief, one of the most error-prone steps of scientific research. It is a widely-used laboratory undertaking, the requirements of which drive what we believe is a large and growing worldwide market. We have developed and patented a novel, enabling technology platform that can control the sample preparation process. It is based on harnessing the unique properties of high hydrostatic pressure. This process, called pressure cycling technology, or PCT, uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels (35,000 psi or greater) to safely, conveniently and reproducibly control the actions of molecules in biological samples, such as cells and tissues from human, animal, plant, and microbial sources.

Our pressure cycling technology uses internally developed instrumentation that is capable of cycling pressure between ambient and ultra-high levels - at controlled temperatures and specific time intervals - to rapidly and repeatedly control the interactions of bio-molecules, such as DNA, RNA, proteins, lipids, and small molecules. Our laboratory instrument, the Barocycler®, and our internally developed consumables product line, including PULSE (Pressure Used to Lyse Samples for Extraction) Tubes, other processing tubes, and application specific kits (which include consumable products and reagents) together make up our PCT Sample Preparation System, or PCT SPS.

We have experienced negative cash flows from operations with respect to our PCT business since our inception. As of December 31, 2013, we did not have adequate working capital resources to satisfy our current liabilities. Based on our current projections, including equity financing subsequent to December 31, 2013, we believe our current cash resources will enable us to extend our cash until August 2014.

As a result, the audit report issued by our independent registered public accounting firm on our consolidated audited financial statements for the fiscal year ended December 31, 2013 contains an explanatory paragraph regarding our ability to continue as a going concern. The audit report issued by our independent registered public accounting firm for our financial statements for the fiscal year ended December 31, 2013 states that there is substantial doubt in our ability to continue as a going concern due to the risk that we may not have sufficient cash and liquid assets at December 31, 2013 to cover our operating and capital requirements for the next twelve-month period; and, if sufficient cash cannot be obtained, we would have to substantially alter or possibly discontinue operations. The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty.

The conditions described above could adversely affect our ability to obtain additional financing on favorable terms, if at all. Such factors may cause investors to have reservations about our long-term prospects and may adversely affect our relationships with customers. There can be no assurance that our auditing firm will not qualify its opinion in the future. If we cannot successfully continue as a going concern, our stockholders may lose their entire investment in us.

Management has developed a plan to continue operations. This plan includes reducing expenses, streamlining operations, and obtaining capital through equity and/or debt financing. Our most recent financing, the second and third tranches of which closed on January 29 and February 28, 2014, respectively, and that is expected to close on or about April 4, 2014, is a private placement (the “Private Placement”) that has resulted in net cash proceeds of $2,849,110 to the Company through March 28, 2014. The Private Placement terms and structure are as follows:
 
 
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On December 12, 2013,  January 29, 2014 and February 28, 2014, we entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with various individuals (each, a “Purchaser”), pursuant to which we sold an aggregate of 4,000 units for a purchase price of $250.00 per unit (the “Purchase Price”), or an aggregate Purchase Price of $1,000,000, 4,875 units for a purchase price of $250.00 per unit, or an aggregate Purchase Price of $1,218,750 and 1,854 units for purchase price of $340.00, or an aggregate Purchase Price of $630,360, respectively.  This represents the first, second and third tranches of the $1.5 million Private Placement which was subsequently increased to $3.5 million.  One or more additional tranches in the Private Placement may close on or before April 4, 2014.  Each unit purchased in the tranches (“Unit”) consists of (i) one share of a newly created series of preferred stock, designated Series K Convertible Preferred Stock, par value $0.01 per share (the “Series K Convertible Preferred Stock”), convertible into 1,000 shares of the Company’s Common Stock, par value $0.01 per share (“Common Stock”) and (ii) a warrant to purchase 500 shares of Common Stock at an exercise price equal to $0.3125 per share in the first and second tranche and $0.425 per share in the third tranche, with a term expiring three years from the respective closing date  (“Warrant”).  Of the $2,849,110 invested in the first three tranches of the Private Placement, $2,028,404 was received in cash and $820,706 was from the conversion of outstanding indebtedness and accrued board of directors’ fees.  The Purchasers in the first three tranches of the Private Placement consisted of certain existing and new investors in the Company as well as all of the members of the Company’s Board of Directors.

Although we have successfully completed equity financings and reduced expenses in the past, we cannot assure you that our plans to address these matters in the future will be successful. Additional financing may not be available to us on a timely basis, if at all, or on terms acceptable to us. In the event we are unable to raise sufficient funds on terms acceptable to us, we may be required to:

  
severely limit or cease our operations or otherwise reduce planned expenditures and forego other business opportunities, which could harm our business. The accompanying financial statements do not include adjustments that may be required in the event of the disposal of assets or the discontinuation of the business;
  
obtain financing with terms that may have the effect of diluting or adversely affecting the holdings or the rights of the holders of our capital stock; or
  
obtain funds through arrangements with future collaboration partners or others that may require us to relinquish rights to some or all of our technologies or products.

We currently focus the majority of our resources in the area of biological sample preparation, referring to a wide range of activities that precede scientific analysis performed by scientists worldwide working in biological life sciences research. Within the broad field of biological sample preparation, we focus the majority of our product development efforts in three specific areas: mass spectrometry, forensics, and histology.

  
Biomarker Discovery - Mass Spectrometry. A biomarker is any substance (e.g., protein) that can be used as an indicator of the presence or absence of a particular disease-state or condition, and to measure the progression and effects of therapy.  Biomarkers can help in the diagnosis, prognosis, therapy, prevention, surveillance, control, and cure of diseases and medical conditions.  A number of laboratory instruments are used to help discover biomarkers; a leader among these is the mass spectrometer. The mass spectrometer is one of the laboratory instruments that is frequently used to help discover biomarkers.

A mass spectrometer is a laboratory instrument used in the analysis of biological samples, primarily proteins, in life sciences research. According to a recently published market report by Transparency Market Research (www.transparencymarketresearch.com) "Spectrometry Market (Atomic, Molecular and Mass Spectrometry) - Global Scenario, Trends, Industry Analysis, Size, Share & Forecast 2011 – 2017," the global spectrometry market was worth $10.2 billion in 2011 and is expected to reach $15.2 billion in 2017, growing at a compounded annual growth rate of 6.9% from 2011 to 2017. In the overall global market, the North American market is expected to maintain its lead position in terms of revenue until 2017 and is expected to have approximately 36.2% of the market revenue share in 2017 followed by Europe. We believe PCT offers significant advantages in speed and quality compared with current techniques used in the preparation of samples for mass spectrometry analysis.

  
Forensics. The detection of DNA has become a part of the analysis of forensic samples by laboratories and criminal justice agencies worldwide in their efforts to identify the perpetrators of violent crimes and missing persons. Scientists from the University of North Texas and Florida International University have reported improvements in DNA yield from forensic samples e.g., bone and hair using PCT in the sample preparation process. We believe that that PCT may be capable of differentially extracting DNA from sperm and (female) epithelial cells in swabs collected from rape victims and stored in rape kits. We believe that there are many completed rape kits that remain untested for reasons such as cost, time, and quality of results. We further believe that the ability to differentially extract DNA from sperm and not epithelial cells could reduce the cost of such testing, while increasing quality, safety, and speed.

  
Histology. The most commonly used technique worldwide for the preservation of cancer and other tissues for subsequent pathology evaluation is formalin-fixation followed by paraffin-embedding. We believe that the quality and analysis of FFPE tissues is highly problematic, and that PCT offers significant advantages over current processing methods, including standardization, speed, biomolecule recovery, and safety.
 
 
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We view federal agency grants to be an important part of our business plan.  These types of grants allow us to bill the federal agency for work that we are planning to perform as part of the development and commercialization of our technology.  We generally start by submitting initial grant requests that are in response to requests for proposals (“RFPs”) from the federal government through their Small Business Innovation Research (“SBIR”) program.  Initial (“SBIR Phase I”) grants are meant to fund approved research projects for six months, and generally have budgets of approximately $100,000 to $150,000.  Because our work in SBIR Phase I grants has been successful, we have applied, and may in the future apply for larger National Institutes of Health (“NIH”) SBIR Phase II grants.  Such larger grants are typically for a two-year period and can offer as much as $1,000,000 to support significant research projects in areas we would otherwise expect to support with internal funds should SBIR Phase II grants not be awarded.  To date, we have been awarded three NIH SBIR Phase I grants and one SBIR Phase II grant.  The data on one of the NIH SBIR Phase I grants were the basis for the submission, and subsequent award, of the NIH SBIR Phase II grant awarded to us in the approximate amount of $850,000 in August 2008.  This NIH SBIR Phase II grant was for work in the area of using PCT to extract protein biomarkers, sub-cellular molecular complexes, and organelles, with the expectation that these studies might ultimately lead to the release of a new, commercially available PCT-based system, with validated protocols, end-user kits, and other consumables intended for the extraction of clinically important protein biomarkers, sub-cellular molecular complexes, and organelles from human and animal tissues.  All three of the NIH SBIR Phase I grants and the NIH SBIR Phase II grant have been completed.

In October 2011, we were awarded a contract of approximately $850,000 from the Department of Defense to help fund the development of a PCT-based system to improve the processing of pathogenic organisms, specifically viruses and bacteria.  The contract funded studies until approximately September 2013.
 
We offer extended service contracts on our laboratory instrumentation to all of our customers.  These service contracts allow a customer who purchases a Barocycler instrument to receive on-site scheduled preventative maintenance, on-site repair and replacement of all worn or defective component parts, and telephone support, all at no incremental cost for the life of the service contract.  We offer one-year and four-year extended service contracts to customers who purchase Barocycler instruments.

RESULTS OF OPERATIONS
 
Year Ended December 31, 2013 as compared with December 31, 2012
 
Revenue
 
We had total revenue of $1,503,288 in the year ended December 31, 2013 as compared with $1,238,217 in the prior year, a 21% increase.
 
Products, Services, and Other. Revenue from the sale of products and services was $1,046,678 in the year ended December 31, 2013 as compared with $809,308 in the year ended December 31, 2012 an increase of $237,370 or 29%. During 2013, we had significant sales to our primary distribution partner in the international markets, Constant Systems.  We generated consumable sales of $157,676 for the year ended December 31, 2013 as compared with $85,493 during the similar period of the prior year, an increase of $72,183, or 84%. Customers order higher volumes of consumables with their initial order of our PCT and CP instrument systems thus consumables sales will increase as more instrument systems are installed.  Sales of our PCT Sample Preparation Accessories increased to $113,435 in 2013 from $93,712 in 2012, an increase of $19,723, or 21%. The number of PCT and CP instrument sales and active leases decreased during 2013 as compared with 2012. The decrease in revenue from instrument sales and leases during 2013 was offset by increased sales of our SG3 Shredder System, sales of the more expensive and higher gross margin Barocycler HUB440 PCT System, and sales of PCT and CP instrument accessories. PCT Instrument Accessories include our MicroTube Adapter Kit Work Stations, Elevated Temperature Kits, Data Acquisition and Control with Software, P-Jump Kit, Reaction Chambers, and EPR Pressure Cells.  Our new Austrian distributor for the SG3 Shredder System purchased 18 systems during 2013.
 
 
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Grant Revenue. During 2013, we recorded $456,610 of grant revenue as compared with $428,909 in 2012. We completed work on a SBIR Phase II contract received from the Department of Defense, or DOD, to fund the development of a PCT-based system to improve the processing of pathogenic organisms in the third quarter of 2013.  We completed all billable work on the grant from the National Institutes of Health, or NIH, to help fund the development of a high pressure-based system to improve the processing of cancer and other samples in the second quarter of 2013.

Cost of Products and Services

The cost of products and services was $567,828 for the year ended December 31, 2013, as compared with $416,415 in 2012. Our gross profit margin on products and services was 46% for the year ended December 31, 2013 vs. 48% at December 31, 2012.  The change is primarily due to lower margins realized on sales of Constant Systems cell disruption products.  The relationship between the cost of products and services and products revenue depends greatly on the mix of instruments we sell, the quantity of such instruments, and the mix of consumable products and instrument accessories that we sell in a given period.

Research and Development

Research and development expenditures were $1,035,426 for 2013 compared to $965,623 in 2012, an increase of $69,803 or 7%. Research and development expense included $56,736 and $30,034 of non-cash, stock-based compensation in 2013 and 2012, respectively.  In addition we incurred additional rent expense of $11,000 in 2013 and $31,250 of additional consulting expense due to our collaboration agreement with a European research lab.
 
Selling and Marketing

Selling and marketing expenses were $752,288 in 2013 compared to $714,635 in 2012, an increase of $37,653, or 5%. This increase was primarily due to our arrangement with Constant Systems whereby we pay Constant Systems for their U.S. based representative who handles sales and service for both CS and PBI products to PBI customers. These additional costs were somewhat offset by lower travel related costs. Selling and Marketing expense included $26,550 and $28,945 of non-cash stock based compensation expense in 2013 and 2012, respectively.
 
General and Administrative

General and administrative costs were $2,474,937 in the year ended December 31, 2013, as compared with $2,605,186 in 2012, a decrease of $130,249 or 5%.  During 2012 we wrote off approximately $263,000 in costs related to an anticipated public offering of stock that we did not complete.  Those savings were offset by increased spending on investor relations and additional travel related costs in 2013 to augment our fund raising efforts. During the years ended December 31, 2013 and 2012, general and administrative expense included $53,509 and $74,212 of non-cash, stock-based compensation expense, respectively.
 
Operating Loss

Our operating loss was $3,327,192 for the year ended December 31, 2013 as compared with $3,463,642 for the prior year, a decrease of $136,450 or 4%. The decreased operating loss was due primarily to the additional gross margin provided by the increase in revenues while holding operating costs relatively flat.

Other income (expense), net

Interest Expense   Net interest expense totaled $339,818 for the year ended December 31, 2013 as compared with interest expense of $133,417 for the year ended December 31, 2012. We amortized approximately $247,244 of imputed interest against the debt discount on short-term loans relating to warrants and conversion options issued with the loans, in 2013.

       Other income (expense) net   We recognized $531,130 in additional expense due to the initial fair value calculation on the conversion option of our convertible debt and the write off of debt discount upon conversion and payoff of the related debt instruments during 2013.
 
 
32

 
 
Change in fair value of derivative liabilities

During the year ended December 31, 2013, we recorded non-cash income of $113,713 from warrant and conversion option liability revaluation in our consolidated statements of operations due to a decrease in the fair value of the conversion option liability on our debt. This decrease in fair value was primarily due to a decrease in the price per share of our Common Stock on December 31, 2013 as compared with the date of issuance of the convertible debt. During the year ended December 31, 2012, we recorded non-cash income of $144,840 for warrant revaluation due to a decrease in fair value of the warrant liability related to warrants issued in our Series D registered direct offering.
 
Income Taxes

We did not record an income tax benefit or provision for the year ended December 31, 2013 and had an income tax benefit of $2,014 for the year ended December 31, 2012.

Net Loss

During the year ended December 31, 2013, we recorded a net loss applicable to Common Stockholders of $5,247,449 or $(0.44) per share, as compared with $4,400,215 or $(0.43) per share during our year ended December 31, 2012.  Although the net loss applicable to Common Stockholders increased in 2013 due to Other Expense, the loss per share remained essentially the same due primarily to the increased number of shares of Common Stock outstanding from the issuance of Common Stock to various service providers in 2013.  See Note 2 of the accompanying Notes to Consolidated Financial Statements under the “Computation of Loss per Share” heading.
 
LIQUIDITY AND FINANCIAL CONDITION

        As of December 31, 2013, we did not have adequate working capital resources to satisfy our current liabilities. On January 29 and February 28, 2014, we entered into a Securities Purchase Agreement with various individuals pursuant to which the Company sold an aggregate of 4,875 and 1,854 units for a purchase price of $250.00 and $340.00 per unit, respectively, or an aggregate Purchase Price of $1,849,110.  This represents the second and third tranches of a $1.5 million private placement. One or more additional tranches in the Private Placement may close on or before April 4, 2014.  Each unit purchased in the second and third tranches consists of (i) one share of a newly created series of preferred stock, designated Series K Convertible Preferred Stock, par value $0.01 per share convertible into 1,000 shares of the Company’s Common Stock, par value $0.01 per share, and (ii) a warrant to purchase 500 shares of Common Stock at an exercise price equal to $0.3125 and $0.425, respectively, with a term expiring three years from the respective closing date. Of the $1,849,110 invested in the second and third tranches of the Private Placement, $1,456,360 was received in cash and $392,750 was from the conversion of outstanding indebtedness and board of directors’ fees.  Of the $2,849,110 invested in the first three tranches of the Private Placement, $2,028,404 was received in cash and $820,706 was from the conversion of outstanding indebtedness and accrued board of directors’ fees.  The Purchasers in the first three tranches of the Private Placement consisted of certain existing and new investors in the Company as well as all of the members of the Company’s Board of Directors.
 
 Based on our current projections, including equity financing subsequent to December 31, 2013, we believe our current cash resources will enable us to extend our cash resources until August 2014.  Although we have successfully completed equity financings and reduced expenses in the past, we cannot assure you that our plans to address these matters in the future will be successful.  If we are not successful there is substantial doubt that we can continue as a going concern.

We believe we will need approximately $6 million in additional capital to fund our three-pronged operational plan, which was designed to help increase revenues by:

A.  
implementing a next-generation upgrade to our product line and offering a superior instrument with greater net margins;

B.  
gaining additional non-dilutive monies from governmental research and development applications, and/or engineering projects; and

C.  
hiring a small team of sales and marketing persons to target research facilities and academic institutions, and cultivate our current customer list of pharmaceutical, military and paramilitary organizations.

 
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However, if we are unable to obtain such funds, through sales, the capital markets or other source of financing on acceptable terms, or at all, we will likely be required to cease our operations, pursue a plan to sell our operating assets, or otherwise modify our business strategy, which could materially harm our future business prospects.

Net cash used in operating activities was $2,342,603 for the year ended December 31, 2013 as compared with $2,164,801 for the year ended December 31, 2012. Our accounts payable balance was $1,102,772 as of December 31, 2013, as compared with to $1,199,846 as of December 31, 2012, a decrease of $97,074 for 2013.  Accounts payable should continue to become more current as we continue to secure more capital and funds from operations allow for more timely payment of our vendors.

We invested $58,749 in fixed assets (lab equipment) during the year ended December 31, 2013 as compared with no investment in fixed assets in the prior year.

Net cash provided by financing activities for the year ended December 31, 2013 was $2,431,308, as compared with $1,943,487 in the prior year.

In 2013, we raised approximately:
 
 
A
$2,034,700 in aggregate gross proceeds from our February 6, March 28 and May 20, 2013 Series J private placement, pursuant to which we sold an aggregate of 5,087.5 units for a purchase price of $400 per unit. Each unit consists of one share of Series J Convertible Preferred Stock, convertible into 1,000 shares of our Common Stock and a three-year warrant to purchase 1,000 shares of our Common Stock at a per share exercise price of $0.40.  Of the $2,034,700 invested in the Series J Private Placement $921,000 was received in cash and $1,113,700 was from the conversion of outstanding indebtedness and accrued board of directors fees.  We incurred fees of $24,405 on this transaction.
 
 
B
$1,000,000 in aggregate gross proceeds from our December 12, 2013 Series K private placement, pursuant to which we sold an aggregate of 4,000 units for a purchase price of $250 per unit. Each unit consists of one share of Series K Convertible Preferred Stock, convertible into 1,000 shares of our Common Stock and a three-year warrant to purchase 500 shares of our Common Stock at a per share exercise price of $0.3125.  Of the $1,000,000 invested in the Series K Private Placement $572,044 was received in cash and $427,956 was from the conversion of outstanding indebtedness.  We incurred fees of $43,334 on this transaction.
 
Loans in the aggregate amount of approximately $1,750,600 were received from eleven lenders.  $565,000 of these loans were converted into our Series J and Series K Convertible Preferred Stock and $482,011 of these loans were paid back by December 31, 2013. An additional $240,600 was repaid in February 2014.  Warrants to purchase 506,000 shares of the Company’s Common Stock were issued to four individuals in connection with these loans.  The warrants have an exercise price ranging from $0.25 to $0.40 per share, with terms expiring August 3, 2016 to January 20, 2017.

Our Common Stock is listed on the Over-the-Counter QB market under the ticker symbol PBIO.
 
COMMITMENTS AND CONTINGENCIES

Royalty Commitments

In 1996, we acquired our initial equity interest in BioSeq, Incorporated (“BioSeq”). At the time, BioSeq was developing our original pressure cycling technology. They acquired its pressure cycling technology from BioMolecular Assays, Inc. (“BMA”) under a technology transfer and patent assignment agreement. In 1998, we purchased all of the remaining, outstanding capital stock of BioSeq; and, consequently, the technology transfer and patent assignment agreement was amended to require us to pay BMA a 5% royalty on our sales of products or services that incorporate or utilize the original pressure cycling technology that BioSeq acquired from BMA. Similarly, the Company is required to pay BMA 5% of the proceeds from any sale, transfer or license of all or any portion of the original pressure cycling technology. These payment obligations terminate in 2016. During the year ended December 31, 2013 and 2012, we incurred approximately $23,785 and $23,634, respectively, in royalty expense associated with our obligation to BMA.

In connection with our acquisition of BioSeq, we licensed certain limited rights to the original pressure cycling technology back to BMA. This license is non-exclusive and limits the use of the original pressure cycling technology by BMA solely for molecular applications in scientific research and development, and in scientific plant research and development. BMA is required to pay us a royalty equal to 20% of any license or other fees and royalties, but not including research support and similar payments, it receives in connection with any sale, assignment, license or other transfer of any rights granted to BMA under the license. BMA must pay us these royalties until the expiration of the patents held by BioSeq in1998, which we anticipate will be 2016. We have not received any royalty payments from BMA under this license.

 
34

 
 
Battelle Memorial Institute

In December 2008, we entered into an exclusive patent license agreement with the Battelle Memorial Institute ("Battelle"). The licensed technology is described in the patent application filed by Battelle on July 31, 2008 (US serial number 12/183,219). This application includes subject matter related to a method and a system for improving the analysis of protein samples including, through an automated system, utilizing pressure and a pre-selected agent to obtain a digested sample in a significantly shorter period of time than current methods, while maintaining the integrity of the sample throughout the preparatory process. Pursuant to the terms of the agreement, we paid Battelle a non-refundable initial fee of $35,000. In addition to royalty payments on net sales on “licensed products,” we are obligated to make minimum royalty payments for each year we retain the rights outlined in the patent license agreement; and, we are required to have our first commercial sale of the licensed products within one year following the issuance of the patent covered by the licensed technology. After re-negotiating the terms of the contract in 2013 the minimum annual royalty was $4,025 and $10,000 for the years ended 2013 for 2012, respectively.

Target Discovery Inc.

In March 2010, we signed a strategic product licensing, manufacturing, co-marketing, and collaborative research and development agreement with Target Discovery Inc. (“TDI”). Under the terms of the agreement, we have been licensed by TDI to manufacture and sell a highly innovative line of chemicals used in the preparation of tissues for scientific analysis ("TDI reagents"). The TDI reagents were designed for use in combination with our pressure cycling technology. The respective companies believe that the combination of PCT and the TDI reagents can fill an existing need in life science research for an automated method for rapid extraction and recovery of intact, functional proteins associated with cell membranes in tissue samples. As of December 31, 2013, we owed TDI a royalty fee of approximately $1,200.

Severance and Change of Control Agreements

Mr. Schumacher and Drs. Ting, Lazarev and Lawrence, all executive officers of the Company, are entitled to receive a severance payment if terminated by us without cause. The severance benefits would include a payment in an amount equal to one year of such executive officer’s annualized base salary compensation plus accrued paid time off. Additionally, the officer will be entitled to receive medical and dental insurance coverage for one year following the date of termination.

Each of these executive officers, other than Mr. Schumacher, is entitled to receive a change of control payment in an amount equal to one year of such executive officer’s annualized base salary compensation, accrued paid time off, and medical and dental coverage, in the event of a change of control of the Company. In the case of Mr. Schumacher, this payment would be equal to two years of annualized base salary compensation, accrued paid time off, and two years of medical and dental coverage. The severance payment is meant to induce the executive to become an employee of the Company and to remain in the employ of the Company, in general, and particularly in the occurrence of a change in control, as a disincentive to the control change.

Lease Commitments

We lease building space under non-cancelable leases in South Easton, MA and in the Venture Development Center at the University of Massachusetts in Boston. Rental costs are expensed as incurred. During 2013 and 2012 we incurred $123,600 and $117,600, respectively, in rent expense for the use of our corporate office and research and development facilities

Following is a schedule by years of future minimum rental payments required under operating leases with initial or remaining non-cancelable lease terms in excess of one year as of December 31, 2013:

Year Ended December 31, 2013
 
2014
 
$123,600
Thereafter
 
-
   
$123,600

 
35

 

CRITICAL ACCOUNTING POLICIES

Principles of Consolidation

The consolidated financial statements include the accounts of Pressure BioSciences, Inc., and its wholly-owned subsidiary PBI BioSeq, Inc. All intercompany accounts and transactions have been eliminated in consolidation.

Use of Estimates

To prepare our consolidated financial statements in conformity with accounting principles generally accepted in the United States of America, we are required to make significant estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In addition, significant estimates were made in projecting future cash flows to quantify impairment of assets, deferred tax assets, the costs associated with fulfilling our warranty obligations for the instruments that we sell, and the estimates employed in our calculation of fair value of stock options awarded. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from the estimates and assumptions used.

Revenue Recognition

We recognize revenue in accordance with FASB ASC 605, Revenue Recognition. Revenue is recognized when realized or earned when all the following criteria have been met: persuasive evidence of an arrangement exists; delivery has occurred and risk of loss has passed to the customer; the seller’s price to the buyer is fixed or determinable; and collectability is reasonably assured.

Our current instruments, the Barocycler NEP3229 and NEP2320, require a basic level of instrumentation expertise to set-up for initial operation. To support a favorable first experience for our customers, we send a highly trained technical representative to the customer site to install every Barocycler that we sell, lease, or rent through our domestic sales force. The installation process includes uncrating and setting up the instrument, followed by introductory user training. Product revenue related to current Barocycler instrumentation is recognized upon the completion of the installation and introductory training process of the instrumentation at the customer location, for domestic and foreign installations. Product revenue related to sales of PCT instrumentation to our foreign distributors is recognized upon shipment through a common carrier. We provide for the expected costs of warranty upon the recognition of revenue for the sales of our instrumentation. Our sales arrangements do not provide our customers with a right of return. Product revenue related to our consumable products such as PULSE Tubes, MicroTubes, and application specific kits is recorded upon shipment through a common carrier. Shipping costs are included in sales and marketing expense. Any shipping costs billed to customers are recognized as revenue.

In accordance with FASB ASC 840, Leases, we account for our lease agreements under the operating method. We record revenue over the life of the lease term and we record depreciation expense on a straight-line basis over the thirty-six month estimated useful life of the Barocycler instrument. The depreciation expense associated with assets under lease agreement is included in the “Cost of PCT products and services” line item in our accompanying consolidated statements of operations. Many of our lease and rental agreements allow the lessee to purchase the instrument at any point during the term of the agreement with partial or full credit for payments previously made. We pay all maintenance costs associated with the instrument during the term of the leases.

Revenue from government grants is recorded when expenses are incurred under the grant in accordance with the terms of the grant award.

Our transactions sometimes involve multiple elements i.e., products and services. Revenue under multiple element arrangements is recognized in accordance with FASB ASC 605-25 Multiple-Element Arrangements (“ASC 605”). When vendor specific objective evidence or third party evidence of selling price for deliverables in an arrangement cannot be determined, the Company develops a best estimate of the selling price to separate deliverables, and allocates arrangement consideration using the relative selling price method. Additionally, this guidance eliminates the residual method of allocation. If an arrangement includes undelivered elements that are not essential to the functionality of the delivered elements, we defer the fair value of the undelivered elements with the residual revenue allocated to the delivered elements. Fair value is determined based upon the price charged when the element is sold separately. If there is not sufficient evidence of the fair value of the undelivered elements, no revenue is allocated to the delivered elements and the total consideration received is deferred until delivery of those elements for which objective and reliable evidence of the fair value is not available. We provide certain customers with extended service contracts with revenue recognized ratably over the life of the contract.
 
 
36

 
 
Intangible Assets

We have classified as intangible assets, costs associated with the fair value of certain assets of businesses acquired. Intangible assets relate to the remaining value of acquired patents associated with PCT. The cost of these acquired patents is amortized on a straight-line basis over sixteen years. We annually review our intangible assets for impairment. When impairment is indicated, any excess of carrying value over fair value is recorded as a loss. An impairment analysis of intangible assets as of December 31, 2013 concluded they were not impaired.

Long-Lived Assets and Deferred Costs

In accordance with FASB ASC 360-10-05, Property, Plant, and Equipment, if indicators of impairment exist, we assess the recoverability of the affected long-lived assets by determining whether the carrying value of such assets can be recovered through the undiscounted future operating cash flows related to the long-lived assets. If impairment is indicated, we measure the amount of such impairment by comparing the carrying value of the asset to the fair value of the asset and record the impairment as a reduction in the carrying value of the related asset and a charge to operating results. While our current and historical operating losses and cash flow are indicators of impairment, we performed an impairment analysis at December 31, 2013 and determined that our long-lived assets were not impaired.

Warrant Derivative Liability

The warrants issued in connection with the registered direct offering of Series D Convertible Preferred Stock (the “Series D Warrants”) are measured at fair value and liability-classified because the Series C Warrants and  Series D Warrants contained “down-round protection” and therefore, did not meet the scope exception for treatment as a derivative under ASC 815, Derivatives and Hedging, Since “down-round protection” is not an input into the calculation of the fair value of the warrants, the warrants cannot be considered indexed to the Company’s own stock which is a requirement for the scope exception as outlined under ASC 815. The estimated fair value of the warrants was determined using the binomial model, resulting in an allocation of the gross proceeds of $283,725 to the warrants issued in the Series D registered direct offering. The fair value will be affected by changes in inputs to that model including our stock price, expected stock price volatility, the contractual term, and the risk-free interest rate. We will continue to classify the fair value of the warrants as a liability until the warrants are exercised, expire or are amended in a way that would no longer require these warrants to be classified as a liability, whichever comes first. The down-round protection for the Series D Warrants survives for the life of the Series D Warrants which ends in May 2017.

Conversion Option Liability

The Company signed five convertible notes and has determined that conversion options are embedded in the notes and it is required to bifurcate the conversion option from the host contract under ASC 815 and account for the derivatives at fair value. The estimated fair value of the conversion options was determined using the binomial model. The fair value of the conversion options will be classified as a liability until the debt is converted by the note holders or paid back by the Company.  The fair value will be affected by changes in inputs to that model including our stock price, expected stock price volatility, the contractual term, and the risk-free interest rate.  We will continue to classify the fair value of the conversion options as a liability until the conversion options are exercised, expire or are amended in a way that would no longer require these conversion options to be classified as a liability, whichever comes first. The Company has adopted a sequencing policy that reclassifies contracts (from equity to liabilities) with the most recent inception date first.  Thus any available shares are allocated first to contracts with the most recent inception dates.

Accounts Receivable and Allowance for Doubtful Accounts

We maintain allowances for estimated losses resulting from the inability of our customers to make required payments. Judgments are used in determining the allowance for doubtful accounts and are based on a combination of factors. Such factors include historical collection experience, credit policy and specific customer collection issues. In circumstances where we are aware of a specific customer’s inability to meet its financial obligations to us (e.g., due to a bankruptcy filing), we record a specific reserve for bad debts against amounts due to reduce the net recognized receivable to the amount we reasonably believe will be collected. We perform ongoing credit evaluations of our customers and continuously monitor collections and payments from our customers. While actual bad debts have historically been within our expectations and the provisions established, we cannot guarantee that we will continue to experience the same bad debt rates that we have in the past. A significant change in the liquidity or financial position of any of our customers could result in the uncollectability of the related accounts receivable and could adversely impact our operating cash flows in that period.

 
37

 
 
Inventories.
 
We value our inventories at lower of cost or market. Cost is determined by the first-in, first-out (FIFO) method, including material, labor and factory overhead. In assessing the ultimate realization of inventories, management judgment is required to determine the reserve for obsolete or excess inventory. Inventory on hand may exceed future demand either because the product is obsolete, or because the amount on hand is more than can be used to meet future needs. We provide for the total value of inventories that we determine to be obsolete or excess based on criteria such as customer demand and changing technologies. We historically have not experienced significant inaccuracies in computing our reserves for obsolete or excess inventory.

Equity Transactions.
 
We evaluate the proper classification of our equity instruments that embody an unconditional obligation requiring the issuer to redeem it by transferring assets at a determinable date or that contain certain conditional obligations, typically classified as equity, be classified as a liability. We record financing costs associated with our capital raising efforts in our statements of operations. These include amortization of debt issue costs such as cash, warrants and other securities issued to finders and placement agents, and amortization of preferred stock discount created by in-the-money conversion features on convertible debt and allocates the proceeds amongst the securities based on relative fair values or based upon the residual method. We based our estimates and assumptions on the best information available at the time of valuation, however, changes in these estimates and assumptions could have a material effect on the valuation of the underlying instruments.
 
Stock-Based Compensation.
 
 We account for employee and non-employee director stock-based compensation using the fair value method of accounting. Compensation cost arising from stock options to employees and non-employee directors is recognized using the straight-line method over the vesting period, which represents the requisite service or performance period. The calculation of stock-based compensation requires us to estimate several factors, most notably the term, volatility and forfeitures. We estimate the option term using historical terms and estimate volatility based on historical volatility of our common stock over the option’s expected term. Expected forfeitures based on historical forfeitures in calculating the expense related to stock-based compensation associated with stock awards. Our estimates and assumptions are based on the best information available at the time of valuation, however, changes in these estimates and assumptions could have a material effect on the valuation of the underlying instruments.
 
ITEM 7A.   QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
 
Not Applicable
 
 
38

 
 
ITEM 8.    FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

Report of Independent Registered Public Accounting Firm

To the Board of Directors of
Pressure BioSciences, Inc. and Subsidiary:

We have audited the consolidated balance sheets of Pressure BioSciences, Inc. and Subsidiary (the “Company”) as of December 31, 2013 and 2012 and the related consolidated statements of operations, changes in stockholders’ deficit, and cash flows for the years then ended. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the consolidated financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Pressure BioSciences, Inc. and Subsidiary as of December 31, 2013 and 2012 and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has had recurring net losses and continues to experience negative cash flows from operations. These conditions raise substantial doubt about its ability to continue as a going concern. Management’s plans regarding those matters also are described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.



/s/ MARCUM LLP


Boston, Massachusetts
March 31, 2014


 
39

 
 
PRESSURE BIOSCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
DECEMBER 31, 2013 AND 2012
 
ASSETS
 
2013
   
2012
 
CURRENT ASSETS
           
Cash and cash equivalents
  $ 31,417     $ 1,461  
Accounts receivable
    147,635       216,265  
Inventories, net of reserves of $50,000 at December 31, 2013 and December 31, 2012
    736,676       923,362  
Prepaid income taxes
    7,381       7,381  
Prepaid expenses and other current assets
    85,573       83,435  
Total current assets
    1,008,682       1,231,904  
PROPERTY AND EQUIPMENT, NET
    58,102       30,282  
OTHER ASSETS
               
Deposits
    -       6,472  
Intangible assets, net
    36,498       85,130  
TOTAL ASSETS
  $ 1,103,282     $ 1,353,788  
                 
LIABILITIES AND STOCKHOLDERS' DEFICIT
               
CURRENT LIABILITIES
               
Accounts payable
    1,102,772       1,199,846  
Accrued employee compensation
    149,333       119,338  
Accrued professional fees and other
    615,244       267,936  
Deferred revenue
    28,189       46,466  
Promissory note
    75,000       75,000  
Dividend liability
    -       60,000  
Related party debt
    25,182       98,675  
Convertible debt, net of debt discount of $331,806 at December 31, 2013 and $0 at December 31, 2012
    281,796       863,004  
Other debt
    89,989       -  
Warrant derivative liability
    344,570       160,812  
Conversion option liability
    356,197       -  
Total current liabilities
    3,068,272       2,891,077  
LONG TERM LIABILITIES
               
Deferred revenue
    2,785       2,487  
TOTAL LIABILITIES
    3,071,057       2,893,564  
                 
COMMITMENTS AND CONTINGENCIES (Note 7)
               
STOCKHOLDERS' DEFICIT
               
Series D convertible preferred stock, $.01 par value; 850 shares authorized; 300 shares issued and outstanding on December 31, 2013 and December 31, 2012 (Liquidation value of $300,000)
    3       3  
Series G convertible preferred stock, $.01 par value; 240,000 shares authorized;  145,320 shares issued and outstanding on December 31, 2013 and December 31, 2012
    1,453       1,453  
Series H convertible preferred stock $.01 par value 10,000 shares authorized; 10,000 shares issued and outstanding on December 31, 2013 and  0  at December 31, 2012
    100       -  
Series J convertible preferred stock $.01 par value 6,250 shares authorized; 5,087.5 shares issued and outstanding on December 31, 2013 and  0  at December 31, 2012
    51       -  
Series K convertible preferred stock $.01 par value 15,000 shares authorized; 4,000 shares issued and outstanding on December 31, 2013 and  0  at December 31, 2012
    40       -  
 Common Stock, $.01 par value; 50,000,000 and 20,000,000 shares authorized; 12,024,267 and 12,149,267 shares issued and outstanding on December 31, 2013 and December 31, 2012, respectively
    120,243       121,493  
Warrants to acquire preferred stock and Common Stock
    4,267,402       3,015,996  
Additional paid-in capital
    19,509,921       15,940,818  
Accumulated deficit
    (25,866,988 )     (20,619,539 )
Total stockholders'  deficit
    (1,967,775 )     (1,539,776 )
TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT
  $ 1,103,282     $ 1,353,788  

The accompanying notes are an integral part of these consolidated financial statements.
 
 
40

 
 
PRESSURE BIOSCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE YEARS ENDED DECEMBER 31, 2013 AND 2012
 
   
For the Year Ended
 
   
December 31,
 
   
2013
   
2012
 
             
Revenue:
           
Products, services, other
  $ 1,046,678     $ 809,308  
Grant revenue
    456,610       428,909  
Total revenue
    1,503,288       1,238,217  
                 
Costs and expenses:
               
Cost of PCT products and services
    567,828       416,415  
Research and development
    1,035,426       965,623  
Selling and marketing
    752,288       714,635  
General and administrative
    2,474,938       2,605,186  
Total operating costs and expenses
    4,830,480       4,701,859  
                 
Operating loss
    (3,327,192 )     (3,463,642 )
                 
Other income (expense):
               
Interest expense, net
    (339,818 )     (133,417 )
Other income (expense), net
    (531,130 )     -  
Change in fair value of derivative liabilities
    113,713       144,840  
Total other income (expense)
    (757,235 )     11,423  
                 
Loss before income taxes
    (4,084,427 )     (3,452,219 )
Income tax benefit
    -       2,014  
Net loss
    (4,084,427 )     (3,450,205 )
Accrued and deemed dividends on convertible preferred stock
    (1,163,022 )     (950,010 )
Net loss applicable to common shareholders
  $ (5,247,449 )   $ (4,400,215 )
                 
                 
Net loss per share attributable to common stockholders - basic and diluted
  $ (0.44 )   $ (0.43 )
                 
Weighted average  common  shares outstanding used in basic and diluted net loss per share calculation
    11,821,870       10,154,175  
 
The accompanying notes are an integral part of these consolidated financial statements.
 
 
41

 
 
PRESSURE BIOSCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT
FOR THE YEARS ENDED DECEMBER 31, 2013 AND 2012
 
   
Series C Preferred Stock
   
Series D Preferred Stock
   
Series E Preferred Stock
   
Series G Preferred Stock
   
Series H Preferred Stock
   
Series J Preferred Stock
 
   
Shares
   
Amount
   
Shares
   
Amount
   
Shares
   
Amount
   
Shares
   
Amount
   
Shares
   
Amount
   
Shares
   
Amount
 
BALANCE, January 1, 2012
    88,098     $ 881       743     $ 7      -       -      -     $ -       -     $ -       -     $ -  
    Stock-based compensation
    -       -       -       -       -       -      -       -       -       -       -       -  
    Issuance of Series E convertible preferred stock
    -       -       -       -       500       5       -       -       -       -       -       -  
    Issuance of Series G convertible preferred stock
    -       -       -       -       -       -       120,680       1,207       -       -       -       -  
    Fair value of  common stock for services
    -       -       -       -       -       -       -       -       -       -       -       -  
    Offering costs for issuance of preferred stock
    -       -       -       -       -       -       -       -       -       -       -       -  
 Issuance of warrants in connection short-term loans
    -       -       -       -       -       -       -       -       -       -       -       -  
    Issuance of warrants for services
    -       -       -       -       -       -       24,640       246       -       -       -       -  
    Issuance of Series G preferred stock in lieu of  cash for Board of Director fees
    -       -       -       -       -       -       -       -       -       -       -       -  
    Warrant modifications
    -       -       -       -       -       -       -       -       -       -       -       -  
    Conversion of preferred stock to  common stock
    (88,098 )     (881 )     (443 )     (4 )     (500 )     (5 )     -       -       -       -       -       -  
    Common stock paid-in-kind dividends earned
    -       -       -       -       -       -       -       -       -       -       -       -  
    Series E dividend paid in cash
    -       -       -       -       -       -       -       -       -       -       -       -  
    Issuance of common stock in private placement
    -       -       -       -       -       -       -       -       -       -       -       -  
    Issuance of  common stock for dividends paid-in-kind
    -       -       -       -       -       -       -       -       -       -       -       -  
    Net loss
    -       -       -       -       -       -       -       -       -       -       -       -  
BALANCE, December 31, 2012
    -     $ -       300     $ 3       -     $ -       145,320     $ 1,453       -     $ -       -     $ -  
    Stock-based compensation
    -       -       -       -       -       -       -       -       -       -       -       -  
    Issuance of Series H convertible preferred stock
    -       -       -       -       -       -       -       -       10,000       100       -       -  
    Issuance of Series J convertible preferred stock
    -       -       -       -       -       -       -       -       -       -       5,088       51  
    Issuance of Series K convertible preferred stock
                                                                                               
    Fair value of common stock issued for services
    -       -       -       -       -       -       -       -       -       -       -       -  
    Offering costs for issuance of preferred stock
    -       -       -       -       -       -       -       -       -       -       -       -  
    Issuance of warrants in connection short-term loans
    -       -       -       -       -       -       -       -       -       -       -       -  
    Issuance of warrants for services
    -       -       -       -       -       -       -       -       -       -       -       -  
    Conversion of common stock to preferred stock
    -       -       -       -       -       -       -       -       -       -       -       -  
    Common stock paid-in-kind dividends earned
    -       -       -       -       -       -       -       -       -       -       -       -  
    Dividends earned on preferred stock
    -       -       -       -       -       -       -       -       -       -       -       -  
    Beneficial conversion feature on convertible preferred stock
    -       -       -       -       -       -       -       -       -       -       -       -  
    Reclassification of conversion option liabilities
    -       -       -       -       -       -       -       -       -       -       -       -  
     Net loss
    -       -       -       -       -       -       -       -       -       -       -       -  
BALANCE, December 31, 2013
    -     $ -       300     $ 3       -     $ -       145,320     $ 1,453       10,000     $ 100       5,088     $ 51  
 
The accompanying notes are an integral part of these consolidated financial statements
 
 
42

 
 
PRESSURE BIOSCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT (CONTINUED)
FOR THE YEARS ENDED DECEMBER 31, 2013 AND 2012

   
Series K Preferred Stock
   
Common Stock
   
Stock
   
Additional Paid-In
   
Accumulated
   
Total Stockholders'
   
Shares
   
Amount
   
Shares
   
Amount
     Warrants     Capital     Deficit      Deficit
BALANCE, January 1, 2012
    -       -       6,723,993     $ 67,240     $ 2,203,101     $ 13,823,875     $ (16,503,440 )   $ (408,336 )
Stock-based compensation
    -       -       -       -       -       133,193       -       133,193  
Issuance of Series E convertible preferred stock
    -       -       -       -       -       499,995       -       500,000  
Issuance of Series G convertible preferred stock
    -       -       -       -       104,301       497,867       -       603,375  
Fair value of common stock issued for services
    -       -       1,125,000       11,250       -       343,297       -       354,547  
Offering costs for issuance of preferred stock
    -       -       -       -       -       (194,367 )     -       (194,367 )
Issuance of warrants in connection short-term loans
    -       -       -       -       45,156       -       -       45,156  
Issuance of warrants for services
    -       -       -       -       11,883       -       -       11,883  
Issuance of Series G preferred stock in lieu of cash for Board      of Director fees
    -       -       -       -       20,596       102,358       -       123,200  
Warrant modifications
    -       -       -       -       323,556       -       (190,891 )     132,665  
Conversion of preferred stock to common stock
    -       -       2,723,540       27,235       -       (24,549 )     -       -  
Common stock paid-in-kind dividends earned
    -       -       -       -       -       -       (278,184 )     (278,184 )
Series E dividend paid in cash
    -       -       -       -       -       -       (196,819 )     (196,819 )
Issuance of common stock in private placement
    -       -       971,867       9,719       307,403       482,878       -       800,000  
    Issuance of  common stock for dividends paid-in-kind
    -       -       604,867       6,049       -       276,271       -       284,116  
    Net loss
    -       -       -       -       -       -       (3,450,205 )     (3,450,205 )
BALANCE, December 31, 2012
    -     $ -       12,149,267     $ 121,493     $ 3,015,996     $ 15,940,818     $ (20,619,539 )   $ (1,539,776 )
Stock-based compensation
    -       -       -       -       -       136,796       -       136,796  
Issuance of Series H convertible preferred stock
    -       -       (1,000,000 )     (10,000 )     -       9,900       -       -  
Issuance of Series J convertible preferred stock
    -       -       -       -       885,309       1,149,340       -       2,034,700  
Issuance of Series K convertible preferred stock
    4,000       40                       271,422       728,538               1,000,000  
Fair value of common stock issued for services
    -       -       875,000       8,750       -       467,962       -       476,712  
Offering costs for issuance of preferred stock
    -       -       -       -       -       (67,739 )     -       (67,739 )
Issuance of warrants in connection short-term loans
    -       -       -       -       73,647       -       -       73,676  
Issuance of warrants for services
    -       -       -       -       21,028       -       -       21,028  
Conversion of common stock to preferred stock
    -       -       -       -       -       -       -       -  
Common stock paid-in-kind dividends earned
    -       -       -       -       -       -       -       -  
Dividends earned on preferred stock
    -       -       -       -       -       -       (160,420 )     (160,420 )
Beneficial conversion feature on convertible preferred stock
    -       -       -       -       -       1,002,602       (1,002,602 )     -  
Reclassification of conversion option liabilities
    -       -       -       -       -       141,704       -       141,704  
Net loss
    -       -       -       -       -       -       (4,084,427 )     (4,084,427 )
BALANCE, December 31, 2013
    4,000     $ 40       12,024,267     $ 120,243     $ 4,267,402     $ 19,509,921     $ (25,866,988 )   $ (1,967,775 )

The accompanying notes are an integral part of these consolidated financial statements.
 
 
43

 
 
PRESSURE BIOSCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED DECEMBER 31, 2013 AND 2012
 
   
For the Year Ended
 
   
December 31,
 
   
2013
   
2012
 
CASH FLOWS FROM OPERATING ACTIVITIES:
           
Net loss
  $ (4,084,427 )   $ (3,450,205 )
                 
Adjustments to reconcile net loss to net cash used in operating activities
               
Depreciation and amortization
    79,563       107,519  
Accretion of non-cash interest and amortization of debt issue costs
    708,729       91,315  
Stock-based compensation expense
    136,796       133,193  
Amortization of third party fees paid in restricted common stock
    480,492       489,605  
Net change in inventory reserves
    -       50,000  
Change in fair value of derivative liabilities
    (113,713 )     (144,840 )
Recovery of bad debt expense
    -       (9,600 )
                 
Changes in operating assets and liabilities:
               
Accounts receivable
    68,630       84,988  
Inventories
    186,686       95,651  
Accounts payable
    (97,074 )     309,170  
Accrued employee compensation
    29,995       (61,099 )
Deferred revenue and other accrued expenses
    257,387       119,403  
Prepaid expenses and other current assets
    4,333       20,099  
    Net cash used in operating activities
    (2,342,603 )     (2,164,801 )
                 
CASH FLOWS FROM INVESTING ACTIVITIES:
               
Purchases of property and equipment
    (58,749 )     -  
    Net cash used in investing activities
    (58,749 )     -  
                 
CASH FLOWS FROM FINANCING ACTIVITIES:
               
Borrowings on convertible debt, net of issuance costs
    1,374,297       1,394,000  
Borrowings on related party and other debt, net of issuance costs
    222,000       98,675  
Repayment of related party and other debt
    (180,304 )     -  
Repayment of convertible debt
    (350,000 )     (101,556 )
Payment of dividends
    (60,000 )     (196,818 )
Net proceeds from the issuance of common stock
    -       377,453  
Net proceeds from the issuance of preferred stock
    1,425,315       371,733  
    Net cash provided by financing activities
    2,431,308       1,943,487  
                 
Change in cash and cash equivalents
    29,956       (221,314 )
Cash and cash equivalents, beginning of period
    1,461       222,775  
Cash and cash equivalents, end of period
  $ 31,417     $ 1,461  
                 
SUPPLEMENTAL INFORMATION:
               
Income taxes paid
  $ -     $ 1,900  
Issuance of  common stock dividend on preferred stock
    -       284,116  
Convertible debt exchanged for common stock
    0       387,547  
Debt and accrued interest exchanged for preferred stock
    1,503,530       586,873  
Fair value of  common stock issued for services
    467,964       354,547  
Issuance of preferred stock for board fees
    38,126       123,200  
Warrant modifications
    -       190,891  
Beneficial conversion feature on convertible preferred stock
    1,002,602       -  
    Dividends earned on preferred stock     160,420       27,584  
                 
 
The accompanying notes are an integral part of these consolidated financial statements.
 
 
44

 
 
(1)  
Business Overview, Liquidity and Management Plans

We are focused on solving the challenging problems inherent in biological sample preparation, a crucial laboratory step performed by scientists worldwide working in biological life sciences research. Sample preparation is a term that refers to a wide range of activities that precede most forms of scientific analysis. Sample preparation is often complex, time-consuming, and in our belief, one of the most error-prone steps of scientific research. It is a widely-used laboratory undertaking, the requirements of which drive what we believe is a large and growing worldwide market. We have developed and patented a novel, enabling technology platform that can control the sample preparation process. It is based on harnessing the unique properties of high hydrostatic pressure. This process, called pressure cycling technology, or PCT, uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels (35,000 psi or greater) to safely, conveniently and reproducibly control the actions of molecules in biological samples, such as cells and tissues from human, animal, plant, and microbial sources.

Our pressure cycling technology uses internally developed instrumentation that is capable of cycling pressure between ambient and ultra-high levels - at controlled temperatures and specific time intervals - to rapidly and repeatedly control the interactions of bio-molecules, such as DNA, RNA, proteins, lipids, and small molecules. Our laboratory instrument, the Barocycler®, and our internally developed consumables product line, including PULSE (Pressure Used to Lyse Samples for Extraction) Tubes, other processing tubes, and application specific kits (which include consumable products and reagents) together make up our PCT Sample Preparation System, or PCT SPS.

We have experienced negative cash flows from operations with respect to our pressure cycling technology business since our inception. As of December 31, 2013, we did not have adequate working capital resources to satisfy our current liabilities. Based on our current projections, including equity financing subsequent to December 31, 2013, we believe our current cash resources will enable us to extend our cash until August 2014.

As a result, the audit report issued by our independent registered public accounting firm on our audited financial statements for the fiscal year ended December 31, 2013 contains an explanatory paragraph regarding our ability to continue as a going concern due to the risk that we may not have sufficient cash and liquid assets at December 31, 2013 to cover our operating and capital requirements for the next twelve-month period; and if sufficient cash cannot be obtained, we would have to substantially alter, or possibly even discontinue, operations. The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty.

The conditions described above could adversely affect our ability to obtain additional financing on favorable terms, if at all, and may cause investors to have reservations about our long-term prospects, and may adversely affect our relationships with customers. There can be no assurance that our auditing firm will not qualify its opinion in the future. If we cannot successfully continue as a going concern, our stockholders may lose their entire investment in us. Although we have successfully completed equity financings and reduced expenses in the past, we cannot assure you that our plans to address these matters in the future will be successful.  If we are not successful there is substantial doubt that we can continue as a going concern.

Management has developed a plan to continue operations. This plan includes further reductions in expenses and obtaining equity or debt financing including our most recently completed financing in January and February 2014, our Series K financing round, in which we sold units consisting of convertible preferred shares of and warrants to purchase shares of Common Stock for net aggregate proceeds of approximately $1,849,110 of which approximately $392,750 was from the conversion of outstanding indebtedness and accrued board of directors’ fees  and $1,456,360 in cash. Although we have successfully completed equity financings and reduced expenses in the past, we cannot assure that our plans to address these matters in the future will be successful. Additional financing may not be available to us on a timely basis, if at all, or on terms acceptable to us. In the event we are unable to raise sufficient funds on terms acceptable to us, we may be required to:

  
severely limit or cease our operations or otherwise reduce planned expenditures and forego other business opportunities, which could harm our business. The accompanying financial statements do not include adjustments that may be required in the event of the disposal of assets or the discontinuation of the business;
  
obtain financing with terms that may have the effect of diluting or adversely affecting the holdings or the rights of the holders of our capital stock; or
  
obtain funds through arrangements with future collaboration partners or others that may require us to relinquish rights to some or all of our technologies or products.

Our Common Stock is listed on the Over-the-Counter exchange.
 
 
45

 
 
(2)  
Summary of Significant Accounting Policies

i.  
Principles of Consolidation

The consolidated financial statements include the accounts of Pressure BioSciences, Inc., and its wholly-owned subsidiary PBI BioSeq, Inc. All intercompany accounts and transactions have been eliminated in consolidation.

ii.  
Use of Estimates

To prepare our consolidated financial statements in conformity with accounting principles generally accepted in the United States of America, we are required to make significant estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In addition, significant estimates were made in projecting future cash flows to quantify impairment of assets, deferred tax assets, the costs associated with fulfilling our warranty obligations for the instruments that we sell, and the estimates employed in our calculation of fair value of stock options awarded and warrant derivative liability. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from the estimates and assumptions used.

iii.  
Revenue Recognition

Revenue is recognized when realized or earned when all the following criteria have been met: persuasive evidence of an arrangement exists; delivery has occurred and risk of loss has passed to the customer; the seller’s price to the buyer is fixed or determinable; and collectability is reasonably assured.

Our current instruments, the Barocycler NEP3229 and NEP2320, require a basic level of instrumentation expertise to set-up for initial operation. To support a favorable first experience for our customers, we send a highly trained technical representative to the customer site to install every Barocycler that we sell, lease, or rent through our domestic sales force. The installation process includes uncrating and setting up the instrument, followed by introductory user training. Product revenue related to current Barocycler instrumentation is recognized upon the completion of the installation and introductory training process of the instrumentation at the customer location, for domestic installations. Product revenue related to sales of PCT instrumentation to our foreign distributors is recognized upon shipment through a common carrier. We provide for the expected costs of warranty upon the recognition of revenue for the sales of our instrumentation. Our sales arrangements do not provide our customers with a right of return. Product revenue related to the HUB440 and our consumable products such as PULSE Tubes, MicroTubes, and application specific kits is recorded upon shipment through a common carrier. Shipping costs are included in sales and marketing expense. Any shipping costs billed to customers are recognized as revenue.

We account for our lease agreements under the operating method. We record revenue over the life of the lease term and we record depreciation expense on a straight-line basis over the thirty-six month estimated useful life of the Barocycler instrument. The depreciation expense associated with assets under lease agreement is included in the “Cost of PCT products and services” line item in our consolidated statements of operations. Many of our lease and rental agreements allow the lessee to purchase the instrument at any point during the term of the agreement with partial or full credit for payments previously made. We pay all maintenance costs associated with the instrument during the term of the leases.

Revenue from government grants is recorded when expenses are incurred under the grant in accordance with the terms of the grant award.
 
Revenue from service contracts is recorded ratably over the length of the contract.

Our transactions sometimes involve multiple elements (i.e., products and services). Revenue under multiple element arrangements is recognized in accordance with FASB ASC 605-25 Multiple-Element Arrangements (“ASC 605”). When vendor specific objective evidence or third party evidence of selling price for deliverables in an arrangement cannot be determined, the Company develops a best estimate of the selling price to separate deliverables and allocates arrangement consideration using the relative selling price method. If an arrangement includes undelivered elements that are not essential to the functionality of the delivered elements, we defer the fair value of the undelivered elements to such time as they are delivered. Fair value is determined based upon the price charged when the element is sold separately. If there is not sufficient evidence of the fair value of the undelivered elements the Company uses its best estimate of the value of those items and recognizes revenues based on the relative values of the delivered and undelivered items. We provide certain customers with extended service contracts with revenue recognized ratably over the life of the contract.
 
 
46

 

iv.  
Cash and Cash Equivalents

Our policy is to invest available cash in short-term, investment grade interest-bearing obligations, including money market funds, and bank and corporate debt instruments. Securities purchased with initial maturities of three months or less are valued at cost plus accrued interest, which approximates fair value, and are classified as cash equivalents.

v.  
Research and Development

Research and development costs, which are comprised of costs incurred in performing research and development activities including wages and associated employee benefits, facilities, consumable products and overhead costs that are expensed as incurred. In support of our research and development activities we utilize our Barocycler instruments that are capitalized as fixed assets and depreciated over their expected useful life.

vi.  
Inventories

Inventories are valued at the lower of cost (average cost) or market (sales price). The cost of Barocyclers consists of the cost charged by the contract manufacturer. The cost of manufactured goods includes material, freight-in, direct labor, and applicable overhead. The composition of inventory as of December 31, 2013 and 2012 is as follows:

   
December 31,
 
   
2013
   
2012
 
Raw materials
  $ 147,290     $ 183,655  
Finished goods
    639,386       789,707  
Inventory reserve
    (50,000 )     (50,000 )
Total
  $ 736,676     $ 923,362  
 
vii.  
Property and Equipment

Property and equipment are stated at cost, less accumulated depreciation. For financial reporting purposes, depreciation is recognized using the straight-line method, allocating the cost of the assets over their estimated useful lives of three years for certain laboratory equipment, from three to five years for management information systems and office equipment, and three years for all PCT finished units classified as fixed assets.

viii.  
Intangible Assets

We have classified as intangible assets, costs associated with the fair value of acquired intellectual property. Intangible assets, including patents, are being amortized on a straight-line basis over sixteen years. We perform an annual review of our intangible assets for impairment. When impairment is indicated, any excess of carrying value over fair value is recorded as a loss. An impairment analysis of intangible assets was performed as of December 31, 2013. Based on this analysis, we have concluded that no impairment of intangible assets had occurred.
 
 
47

 

ix.  
Long-Lived Assets and Deferred Costs

The Company’s long-lived assets and other assets are reviewed for impairment in accordance with the guidance of the FASB ASC 360-10-05, Property, Plant, and Equipment, whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. Recoverability of an asset to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted cash flows expected to be generated by the asset. If such asset is considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset exceeds its fair value. Through December 31, 2013, the Company had not experienced impairment losses on its long-lived assets. While our current and historical operating losses and cash flow are indicators of impairment, we performed an impairment test at December 31, 2013 and determined that such long-lived assets were not impaired.
 
x.  
Concentrations

Credit Risk

Our financial instruments that potentially subject us to concentrations of credit risk consist primarily of cash, cash equivalents and trade receivables. We have cash investment policies which, among other things, limit investments to investment-grade securities. We perform ongoing credit evaluations of our customers, and the risk with respect to trade receivables is further mitigated by the fact that many of our customers are government institutions and university labs. Allowances are provided for estimated amounts of accounts receivable which may not be collected.  At December 31, 2013 and 2012, we determined that no allowance against accounts receivable was necessary.

The following table illustrates the level of concentration of the below two groups within revenue as a percentage of total revenues during the years ended December 31, 2013 and 2012:

   
For the Year Ended
 
   
December 31,
 
   
2013
   
2012
 
Top Five Customers
    53 %     50 %
Federal Agencies
    33 %     41 %
 
The following table illustrates the level of concentration of the below two groups within accounts receivable as a percentage of total accounts receivable balance as of December 31, 2012 and 2011:

   
For the Year Ended
 
   
December 31,
 
   
2013
   
2012
 
Top Five Customers
    86 %     34 %
Federal Agencies
    16 %     32 %
 
Product Supply

BIT Group USA, formerly Source Scientific, LLC, has been our sole contract manufacturer for all of our PCT instrumentation. Until we develop a broader network of manufacturers and subcontractors, obtaining alternative sources of supply or manufacturing services could involve significant delays and other costs and challenges, and may not be available to us on reasonable terms, if at all. The failure of a supplier or contract manufacturer to provide sufficient quantities, acceptable quality and timely products at an acceptable price, or an interruption of supplies from such a supplier could harm our business and prospects.

xi.  
Computation of Loss per Share

Basic loss per share is computed by dividing loss available to common shareholders by the weighted average number of common shares outstanding. Diluted loss per share is computed by dividing loss available to common shareholders by the weighted average number of common shares outstanding plus additional common shares that would have been outstanding if dilutive potential common shares had been issued. For purposes of this calculation, convertible preferred stock, common stock dividends, warrants to acquire preferred stock convertible into common stock, and warrants and options to acquire common stock, are all considered common stock equivalents in periods in which they have a dilutive effect and are excluded from this calculation in periods in which these are anti-dilutive. The following table illustrates our computation of loss per share for the years ended December 31, 2013 and 2012.

 
48

 

   
For the Year Ended
 
   
December 31,
 
   
2013
   
2012
 
Numerator:
           
Net loss
  $ (4,084,427 )   $ (3,450,205 )
Accrued dividend for Preferred Stock paid in common stock
    -       (278,184 )
Deemed dividend on warrant modifications
    -       (190,891 )
Issuance of common stock for dividends paid in kind
    -       (284,116 )
Beneficial conversion feature for preferred stock
    (1,002,602 )     -  
Preferred dividends accrued
    (160,420 )     -  
Preferred dividends accrued and paid in cash
    -       (196,819 )
Net loss applicable to common shareholders
  $ (5,247,449 )   $ (4,400,215 )
                 
Denominator for basic and diluted loss per share:
               
Weighted average  common shares outstanding
    11,821,870       10,154,175  
                 
Loss per common share - basic and diluted
  $ (0.44 )   $ (0.43 )
 
The following table presents securities that could potentially dilute basic loss per share in the future. For all periods presented, the potentially dilutive securities were not included in the computation of diluted loss per share because these securities would have been anti-dilutive.
 
   
For the Year Ended
 
   
December 31,
 
   
2013
   
2012
 
Stock options
    1,771,708       1,605,750  
Convertible debt
    2,242,024       -  
Common stock warrants
    15,012,327       6,687,099  
Preferred stock warrants
    -       -  
Convertible preferred stock:
               
Series A Convertible Preferred
    -       -  
Series B Convertible Preferred
    -       -  
Series C Convertible Preferred
    -       -  
Series D Convertible Preferred
    750,000       750,000  
Series E Convertible Preferred
    -       -  
Series G Convertible Preferred
    1,453,200       1,453,200  
Series H Convertible Preferred
    1,000,000       -  
Series J Convertible Preferred
    5,087,500       -  
Series K Convertible Preferred
    4,000,000       -  
      31,316,759       10,496,049  

xii.  
Accounting for Income Taxes

We account for income taxes under the asset and liability method, which requires recognition of deferred tax assets, subject to valuation allowances, and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting and income tax purposes. The Company considers many factors when assessing the likelihood of future realization of our deferred tax assets, including recent cumulative earnings experience by taxing jurisdiction, expectations of future taxable income or loss, the carry-forward periods available to us for tax reporting purposes, and other relevant factors. A valuation allowance is established if it is more likely than not that all or a portion of the net deferred tax assets will not be realized. If substantial changes in the company’s ownership should occur, as defined in Section 382 of the Internal Revenue Code, there could be significant limitations on the amount of net loss carry forwards that could be used to offset future taxable income.
 
 
49

 
 
xiii.  
Accounting for Stock-Based Compensation

We maintain equity compensation plans under which incentive stock options and non-qualified stock options are granted to employees, independent members of our Board of Directors and outside consultants. We recognize equity compensation expense over the requisite service period using the Black-Scholes formula to estimate the fair value of the stock options on the date of grant.

Determining Fair Value of Stock Option Grants

Valuation and Amortization Method - The fair value of each option award is estimated on the date of grant using the Black-Scholes pricing model based on certain assumptions. The estimated fair value of employee stock options is amortized to expense using the straight-line method over the vesting period, which generally is over three years.

Expected Term - The Company uses the simplified calculation of expected life, described in the FASB ASC 718, Compensation-Stock Compensation, as the Company does not currently have sufficient historical exercise data on which to base an estimate of expected term. Using this method, the expected term is determined using the average of the vesting period and the contractual life of the stock options granted.

Expected Volatility - Expected volatility is based on the Company’s historical stock volatility data over the expected term of the award.

Risk-Free Interest Rate - The Company bases the risk-free interest rate used in the Black-Scholes valuation method on the implied yield currently available on U.S. Treasury zero-coupon issues with an equivalent remaining term.

Forfeitures - As required by FASB ASC 718, Compensation-Stock Compensation, the Company records stock-based compensation expense only for those awards that are expected to vest. The Company estimated a forfeiture rate of 5% for awards granted based on historical experience and future expectations of options vesting. We used this historical rate as our assumption in calculating future stock-based compensation expense.

The following table summarizes the assumptions we utilized for grants of stock options to the three sub-groups of our stock option recipients during the twelve months ended December 31, 2013 and 2012:
 
Assumptions
 
Non-Employee Board Members
 
CEO, other Officers and Employees
Expected life
 
2.0-5.0 (yrs)
 
6.0 (yrs)
Expected volatility
  55.66%-134.75%   55.66%-124.89%
Risk-free interest rate
  1.00%-4.94%   0.50%-4.94%
Forfeiture rate
  0.00%-5.00%   2.00%-5.00%
Expected dividend yield
  0.0%   0.0%

On August 15, 2012, the Board of Directors approved the immediate re-pricing of certain outstanding stock options (approximately 1,555,500 shares) held by current officers, employees and board members with outstanding stock options to $1.00 per share, a 200% premium to the closing market price on August 15, 2012 of $0.32, for original stock options with an exercise price above $1.00, to $0.60 per share, a 88% premium to the closing market price on August 15, 2012 of $0.32, for original stock options with an exercise price below $1.00 but above $0.60.  The compensation value created by the re-pricing, as determined under the Black-Scholes method, was approximately $62,000 and under current accounting rules results in a non-cash expense in current and future periods, not to exceed the vesting periods of the stock options.

 
50

 
 
Assumptions for re-pricing of the options were:
 
Assumptions
 
Awards re-priced during the year ended
 December 31,
2012
 
Expected life (in years)
    6  
Weighted average expected volatility
    124.9 %
Risk-free interest rate
    0.7 %
Weighted average re-priced Black-Scholes calculated fair value
    0.32  
 
We recognized stock-based compensation expense of $136,796 and $133,193 for the years ended December 31, 2013 and 2012, respectively. The following table summarizes the effect of this stock-based compensation expense within each of the line items within our accompanying Consolidated Statements of Operations:

   
For the Year Ended
December 31,
 
   
2013
   
2012
 
Research and development
  $ 53,509     $ 30,034  
Selling and marketing
    26,551       28,944  
General and administrative
    56,736       74,215  
Total stock-based compensation expense
  $ 136,796     $ 133,193  

During the years ended December 31, 2013 and 2012, the total fair value of stock options awarded was $128,642 and $116,816, respectively.

As of December 31, 2013, the total estimated fair value of unvested stock options to be amortized over their remaining vesting period was $65,953. The non-cash, stock based compensation expense associated with the vesting of these options will be $45,598 in 2014, $18,575 in 2015, and $1,780 in 2016.

xiv.  
Fair Value of Financial Instruments

Due to their short maturities, the carrying amounts for cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their fair value. Short-term and long-term liabilities are primarily related to liabilities transferred under contractual arrangements with carrying values that approximate fair value.

xv.  
Advertising

        Advertising costs are expensed as incurred. During 2013 we did not spend anything on advertising.  We incurred $500 in advertising expense in 2012.
 
xvi.  
Fair Value Measurements

The Company follows the guidance of FASB ASC Topic 820, “Fair Value Measurements and Disclosures” (“ASC 820”) as of June 30, 2012, as it related to all financial assets and financial liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis.

The Company generally defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company uses a three-tier fair value hierarchy, which classifies the inputs used in measuring fair values. These tiers include: Level 1, defined as observable inputs such as quoted prices for identical instruments in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions.

Financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company has determined that it does not have any financial assets measured at fair value and that its financial liabilities are currently all classified within Level 3 in the fair value hierarchy.

 
51

 
 
The following tables set forth the Company’s financial liabilities that were accounted for at fair value on a recurring basis as of December 31, 2013 and December 31, 2012. The assumptions used to determine fair value of the warrants are contained in the table in Note 7 of the accompanying consolidated financial statements. The development of the unobservable inputs for Level 3 fair value measurements and fair value calculations are the responsibility of the Company’s management.

         
Fair value measurements at December 31, 2013 using:
 
   
December 31,
2013
   
Quoted prices in active markets (Level 1)
   
Significant other observable inputs (Level 2)
   
Significant unobservable inputs
(Level 3)
 
Series D Common Stock Purchase Warrants
  $ 344,570     $ -     $ -     $ 344,570  
 
         
Fair value measurements at December 31, 2012 using:
 
   
December 31,
2012
   
Quoted prices in active markets (Level 1)
   
Significant other observable inputs (Level 2)
   
Significant unobservable inputs
(Level 3)
 
Series D Common Stock Purchase Warrants
  $ 160,812     $ -     $ -     $ 160,812  
 
   
January 1,
2013
   
Change in Fair Value
   
December 31,
2013
 
Series D Common Stock Purchase Warrants
  $ 160,812     $ 183,758     $ 344,570  
 
   
January 1,
2012
   
Change in Fair Value
   
December 31,
2012
 
Series D Common Stock Purchase Warrants
  $ 231,200     $ (70,388 )   $ 160,812  
 
   
Fair value measurements at December 31, 2013 using:
 
   
December 31,
2013
   
Quoted prices in active markets (Level 1)
   
Significant other observable inputs (Level 2)
   
Significant unobservable inputs
 (Level 3)
 
April 11, 2013 note, conversion option
  $ 130,734       -       -     $ 130,734  
June 26, 2013 note, conversion option
    55,307       -       -       55,307  
December 4, 2013 note, conversion option
    98,129       -       -       98,129  
December 23, 2013 note, conversion option
    72,027       -       -       72,027  
Embedded conversion options
  $ 356,197       -       -     $ 356,197  
 
   
 January 1,
2013
  Issuance date fair value    
Change in fair
value
   
Reclassification
into equity
   
December 31,
2013
 
April 11, 2013 note, conversion option
$  -   $ 274,840     $ (144,106 )   $ -     $ 130,734  
 May 24, 2013 note, conversion option
   -     122,223       (18,702 )     (103,521 )     -  
 June 6, 2013 note, conversion option
   -     158,715       (120,535 )     (38,180 )     -  
 June 26, 2013 note, conversion option
   -     84,146       (28,839 )     -       55,307  
December 4, 2013 note, conversion option
   -     90,444       7,685       -       98,129  
December 23, 2013 note, conversion option
   -     65,033       7,024       -       72,027  
Embedded conversion options
$  -   $ 795,371     $ (297,471 )   $ (141,701 )   $ 356,197  

The assumptions for the binomial pricing model are represented in the table below for the conversion options reflected on a per share common stock equivalent basis.
 
 
52

 
 
Assumptions
 
April 11,
2013
   
Conversion options revalued at
December 31,
2013
 
Expected life (in months)
    12       4  
Expected volatility
    206.2 %     149.9 %
Risk-free interest rate
    0.10 %     0.04 %
Exercise price
  $ 0.14     $ 0.14  
Fair value per conversion option
  $ 0.29     $ 0.13  

Assumptions
 
May 24,
2013
   
Conversion options revalued at
November 22,
2013
 
Expected life (in months)
    24       18  
Expected volatility
    170.0 %     181.8 %
Risk-free interest rate
    0.27 %     0.35 %
Exercise price
  $ 0.25     $ 0.17  
Fair value per conversion option
  $ 0.31     $ 0.17  

Assumptions
 
June 6,
2013
   
Conversion options revalued at
December 26,
2013
 
Expected life (in months)
    12       5  
Expected volatility
    209.7 %     132.9 %
Risk-free interest rate
    0.13 %     0.07 %
Exercise price
  $ 0.40     $ 0.40  
Fair value per conversion option
  $ 0.25     $ 0.06  

Assumptions
 
June 26,
2013
   
Conversion options revalued at
December 31,
2013
 
Expected life (in months)
    12       6  
Expected volatility
    189.2 %     136.5 %
Risk-free interest rate
    0.13 %     0.07 %
Exercise price
  $ 0.17     $ 0.14  
Fair value per conversion option
  $ 0.26     $ 0.14  

Assumptions
 
December 4,
2013
   
Conversion options revalued at
December 31,
2013
 
Expected life (in months)
    24       23  
Expected volatility
    170.3 %     170.3 %
Risk-free interest rate
    0.30 %     0.38 %
Exercise price
  $ 0.40     $ 0.40  
Fair value per conversion option
  $ 0.16     $ 0.18  

Assumptions
 
December 23,
2013
   
Conversion options revalued at
December 31,
2013
 
Expected life (in months)
    36       36  
Expected volatility
    151.4 %     152.5 %
Risk-free interest rate
    0.77 %     0.78 %
Exercise price
  $ 0.40     $ 0.40  
Fair value per conversion option
  $ 0.17     $ 0.19  
 
Deferred Fiancing Costs: We evaluate the proper classification of our equity instruments that embody an unconditional obligation requiring the issuer to redeem it by transferring assetss at a determinable date or that contain certain conditional obligations, typically classified as equity, be classified as a liability. We record financing costs associated with our capital raising efforts in our statements of operations. These include amortization of debt issue costs such as cash, warrants and other securities issued to finders and placement agents, and amortization of preferred stock discount created by in-the-money conversion features on convertible debt and allocates the proceeds amongst the securities based on relative fair values or based upon the residual method. We based our estimates and assumptions on the best information available at the time of valuation, however, changes in these estimates and assumptions could have a material effect on the valuation of the underlying instruments. 
 
 
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(3)  
Property and Equipment, net

Property and equipment as of December 31, 2013 and 2012 consisted of the following components:
 
   
December 31,
 
   
2013
   
2012
 
Laboratory and manufacturing equipment
  $ 226,081     $ 172,560  
Office equipment
    142,323       137,093  
Leasehold improvements
    8,117       8,117  
PCT collaboration, demonstration and leased systems
    461,858       461,858  
Total property and equipment
    838,379       779,628  
Less accumulated depreciation
    (780,277 )     (749,346 )
Net book value
  $ 58,102     $ 30,282  

Depreciation expense for the years ended December 31, 2013 and 2012 was $30,931 and $58,889, respectively.

(4)  
Intangible Assets, net

Intangible assets as of December 31, 2013 reflect the purchase price attributable to patents in connection with the 1998 acquisition of BioSeq, Inc. and the PCT business. Acquired PCT patents are being amortized to expense on a straight line basis at the rate of $48,632 per year over their estimated remaining useful lives of approximately 1 year. We performed a review of our intangible assets for impairment. When impairment is indicated, any excess of carrying value over fair value is recorded as a loss. An impairment analysis of intangible assets was performed as of December 31, 2013. We have concluded that there is no impairment of intangible assets. Intangible assets at December 31, 2013 and 2012 consisted of the following:
 
   
December 31,
 
   
2013
   
2012
 
PCT Patents
  $ 778,156     $ 778,156  
Less accumulated amortization
    (741,658 )     (693,026 )
Net book value
  $ 36,498     $ 85,130  
 
Amortization expense for each of the years ended December 31, 2013 and 2012 was $48,632 and is expected to be $36,498 in 2014, at which time the assets will be fully amortized.

(5)  
Retirement Plan

We provide all of our employees with the opportunity to participate in our retirement savings plan. Our retirement savings plan has been qualified under Section 401(k) of the Internal Revenue Code. Eligible employees are permitted to contribute to the plan through payroll deductions within statutory limitations and subject to any limitations included in the plan. During 2013 and 2012 we contributed $10,377 and $12,458, respectively, in the form of discretionary Company-matching contributions.
 
(6)  
Income Taxes

The components of the benefit for income taxes are as follows:

       We did not record an income tax benefit or provision for the year ended December 31, 2013. We recorded a $2,014 income tax benefit for the year ended December 31, 2012.

 
54

 
 
        Significant items making up the deferred tax assets and deferred tax liabilities as of December 31, 2013 and December 31, 2012 are as follows:

   
December 31,
 
Current deferred taxes
 
2013
   
2012
 
          Inventories
  $ 19,640     $ 19,723  
          Accounts Receivable allowance
    -       -  
          Other accruals
    23,050       45,053  
           Less: valuation allowance
    (42,690 )     (64,776 )
                   Total current deferred tax assets
  $ -     $ -  
Long term deferred taxes:
               
Accelerated tax depreciation
  $ 29,511     $ 32,686  
Non-cash, stock-based compensation, nonqualified
    387,708       388,506  
Goodwill and intangibles
    (14,337 )     (33,580 )
Operating loss carry forwards and tax credits
    8,938,681       7,643,661  
Less: valuation allowance
    (9,341,563 )     (8,031,273 )
Total long term deferred tax assets (liabilities), net
    -       -  
Total net deferred tax liabilities
  $ -     $ -  

A valuation allowance is established if it is more likely than not that all or a portion of the deferred tax asset will not be realized. Accordingly, a valuation allowance was established in 2013 and 2012 for the full amount of our deferred tax assets due to the uncertainty of realization. We believe based on our projection of future taxable operating income for the foreseeable future, it is more likely than not that we will not be able to realize the benefit of the deferred tax asset at December 31, 2013.

We have net operating loss carry-forwards for federal income tax purposes of $17,668,501 as of December 31, 2013. Included in these numbers are loss carry-forwards that were obtained through the acquisition of BioSeq, Inc. and are subject to Section 382 NOL limitations. These net operating loss carry-forwards expire at various dates from 2014 through 2033.

We had net operating loss carry-forwards for state income tax purposes of approximately $19,959,028 at December 31, 2013. These net operating loss carry-forwards expire at various dates from 2014 through 2033.
 
We have research
 
We have research  and development tax credit carryforwards for federal income tax purposes of approximately $940,000 as of December 31, 2013, and research and development tax credit carryforwards for state income tax purposes of approximately $140,000 as of December 31, 2013. The federal credit carryforwards expire at various dates from 2014 through 2033. The state credit carryforwards expire at various dates from 2014 through 2028.

In addition, we have federal alternative minimum tax credit carryforwards for federal income tax purposes of approximately $217,000 as of December 31, 2013. These credits do not expire.
 
Our effective income tax (benefit) provision rate was different than the statutory federal income tax (benefit) provision rate as follows:

   
For the Year Ended
 
   
December 31,
 
   
2012
   
2012
 
Federal tax (benefit) provision rate
    34 %     34 %
Permanent differences
    (3 ) %     (1 ) %
State tax expense
    0 %     0 %
Refundable AMT and R&D tax credit
    0 %     0 %
Net operating loss carry back
    0 %     0 %
Valuation allowance
    (31 ) %     (33 ) %
Effective income tax (benefit) provision rate from continuing operations
    0 %     0 %

(7)  
Commitments and Contingencies

Operating Leases

Our corporate office is currently located at 14 Norfolk Avenue, South Easton, Massachusetts 02375.   We are currently paying approximately $4,800 per month for our corporate office. On December 31, 2013 the lease was amended to extend the expiration date to December 31, 2014 at the rate of $4,800 per month.
 
Effective January 1, 2010, we entered into a three-year lease agreement with the University of Massachusetts in Boston, pursuant to which we are leasing laboratory and office space on campus at the university for research and development activities. We paid $5,000 per month for the use of these facilities.  On September 26, 2012, the lease was amended to extend the expiration date to December 31, 2014 at a rate of $5,500 per month.

 
55

 
 
Following is a schedule by years of future minimum rental payments required under operating leases with initial or remaining non-cancelable lease terms in excess of one year as of December 31, 2013:

   
Year ending
December 31:
 
2014
  $ 123,600  
Thereafter
    -  
 Total minimum payments required
  $ 123,600  

      Royalty Commitments

      BioMolecular Assays, Inc.

In 1996, we acquired our initial equity interest in BioSeq, Inc., which at the time was developing our original pressure cycling technology. BioSeq, Inc. acquired its pressure cycling technology from BioMolecular Assays, Inc. under a technology transfer and patent assignment agreement. In 1998, we purchased all of the remaining outstanding capital stock of BioSeq, Inc., and at such time, the technology transfer and patent assignment agreement was amended to require us to pay BioMolecular Assays, Inc. a 5% royalty on our sales of products or services that incorporate or utilize the original pressure cycling technology that BioSeq, Inc. acquired from BioMolecular Assays, Inc. We are also required to pay BioMolecular Assays, Inc. 5% of the proceeds from any sale, transfer or license of all or any portion of the original pressure cycling technology. These payment obligations terminate in 2016. During the fiscal years ended December 31, 2013 and 2012, we incurred $23,785 and $23,635 in royalties, respectively.

In connection with our acquisition of BioSeq, Inc., we licensed certain limited rights to the original pressure cycling technology back to BioMolecular Assays, Inc.  This license is non-exclusive and limits the use of the original pressure cycling technology by BioMolecular Assays, Inc. solely for molecular applications in scientific research and development and in scientific plant research and development. BioMolecular Assays, Inc. is required to pay us a royalty equal to 20% of any license or other fees and royalties, but not including research support and similar payments, it receives in connection with any sale, assignment, license or other transfer of any rights granted to BioMolecular Assays, Inc. under the license. BioMolecular Assays, Inc. must pay us these royalties until the expiration of the patents held by BioSeq, Inc. in 1998, which we anticipate will be 2016. We have not received any royalty payments from BioMolecular Assays, Inc. under this license.

Battelle Memorial Institute

In December 2008, we entered into an exclusive patent license agreement with the Battelle Memorial Institute ("Battelle"). The licensed technology is described in the patent application filed by Battelle on July 31, 2008 (US serial number 12/183,219). This application includes subject matter related to a method and a system for improving the analysis of protein samples, including through an automated system utilizing pressure and a pre-selected agent to obtain a digested sample in a significantly shorter period of time than current methods, while maintaining the integrity of the sample throughout the preparatory process. Pursuant to the terms of the agreement, we paid Battelle a non-refundable initial fee of $35,000. In addition to royalty payments on net sales on “licensed products”, we are obligated to make minimum royalty payments for each year that we retain the rights outlined in the patent license agreement and we are required to have our first commercial sale of the licensed products within one year following the issuance of the patent covered by the licensed technology. After re-negotiating the contract in 2013 our only obligation for 2013 was a minimum royalty payment of $4,025.  The minimum annual royalty was $10,000 for 2012.

Target Discovery Inc.

In March 2010, we signed a strategic product licensing, manufacturing, co-marketing, and collaborative research and development agreement with Target Discovery Inc. (“TDI”). Under the terms of the agreement, we have been licensed by TDI to manufacture and sell a highly innovative line of chemicals used in the preparation of tissues for scientific analysis ("TDI reagents"). The TDI reagents were designed for use in combination with our pressure cycling technology. The companies believe that the combination of PCT and the TDI reagents can fill an existing need in life science research for an automated method for rapid extraction and recovery of intact, functional proteins associated with cell membranes in tissue samples. We did not incur any royalty obligation under this agreement in 2013 or 2012.

Severance and Change of Control Agreements
 
Each of Mr. Schumacher, and Drs. Ting, Lazarev, and Lawrence, executive officers of the Company, are entitled to receive a severance payment if terminated by us without cause. The severance benefits would include a payment in an amount equal to one year of such executive officer’s annualized base salary compensation plus accrued paid time off. Additionally, the officer will be entitled to receive medical and dental insurance coverage for one year following the date of termination.
 
 
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Each of these executive officers, other than Mr. Schumacher, is entitled to receive a change of control payment in an amount equal to one year of such executive officer’s annualized base salary compensation, accrued paid time off, and medical and dental coverage, in the event of a change of control of the Company. In the case of Mr. Schumacher, this payment would be equal to two years of annualized base salary compensation, accrued paid time off, and two years of medical and dental coverage. The severance payment is meant to induce the aforementioned executives to remain in the employ of the Company, in general; and particularly in the occurrence of a change in control, as a disincentive to the control change.

Promissory Note

On November 4, 2011, the Company entered into an agreement with a former placement agent, pursuant to which the Company and the placement agent released each other of their respective obligations under a prior investment banking agreement.  In connection with this agreement, the Company issued the placement agent a promissory note with an original principal amount of $150,000 and a maturity date of May 4, 2012.  The promissory note was interest free until May 4, 2012.  On November 15, 2012, $75,000 of principal and $16,125 of accrued and unpaid interest were converted into 18,225 shares of the Company’s Series G Convertible Preferred Stock. The $75,000 principal balance remaining as of December 31, 2013 earns interest at a rate of 18% per year. The entire note balance along with all accrued interest was paid off in February 2014.

Convertible Debt

Loans in the aggregate amount of $155,000 were received from two individuals in 2013. We accrued interest at a rate of 6% on the loans.   These loans, along with $863,000 of other prior outstanding loans and unpaid interest, were converted to the Company’s Series J Convertible Preferred Shares in February 2013.

On April 11, 2013, we signed a promissory note in the amount of $275,000.  The lender paid $125,000, net of $12,500 of original issue discount, upon closing of the note.  The lender paid an additional $50,000, net of $5,000 original issue discount, on June 26, 2013. The balance of the Consideration shall be paid in the amounts and the dates as the lender chooses.  The note and unpaid interest on the note are due and payable one year from the effective date of each payment.  The Company has the right to repay the notes at any time within six months of the effective date of each closing.  If the Company repays the note within 90 days of the effective date interest is 0%.  If the note is not repaid within the 90 days a onetime interest charge of 12% will be applied. The Company has reserved at least 6,000,000 shares of common stock for conversion under this note.  The Company evaluated the terms of this note in accordance with ASC 815-40, Derivatives and Hedging Contracts in Entity’s Own Stock. The lender has the right to convert all or part of the unpaid principal and interest into common stock at a conversion price of 60% of the lowest trade price in the 25 trading days prior to conversion after six months from the effective date of each closing. The Company determined that the conversion feature met the definition of a liability and therefore, bifurcated the conversion feature as a derivative liability. The derivative liability is measured at the end of each reporting period and the change in fair value is recorded as other expense or income in the statement of operations. The fair value of the conversion feature was $186,041 at December 31, 2013 and reflected in the conversion option liability line in the consolidated balance sheet. On October 10, 2013, this note was amended to change the lenders right to convert and the borrower’s right to repay to December 10, 2013. On December 10, 2013, this note was amended to change the lenders right to convert and the borrower’s right to repay to February 10, 2014.
 
The proceeds from the convertible debt issued on April 11, 2013, were allocated between the host debt instrument and the convertible option based on the residual method.  The estimated fair value of the convertible option was determined using a binomial formula, resulting in an allocation of $274,840 to the convertible option and accounted for as a liability in the Company’s consolidated balance sheet. In accordance with the provisions of ASC 815-40, the entire gross proceeds of $137,500 was offset by a debt discount of $137,500 which will be amortized to interest expense over the twelve month life of the debt. The additional $149,840 adjustment between the convertible option liability and the debt discount was charged directly to other expense.

The proceeds from the convertible debt issued on June 26, 2013, were allocated between the host debt instrument and the convertible option based on the residual method.  The estimated fair value of the convertible option was determined using a binomial formula, resulting in an allocation of $84,146 to the convertible option and accounted for as a liability in the Company’s consolidated balance sheet. In accordance with the provisions of ASC 815-40, the entire gross proceeds of $55,000 was offset by a debt discount of $55,000 which will be amortized to interest expense over the twelve month life of the debt. The additional $34,146 adjustment between the convertible option liability and the debt discount was charged directly to other expense.

 
57

 
So long as the note is outstanding, the Company shall notify the lender of the issuance of any security with a term more favorable to the holder, and the lender may at its option, include the terms as a part of the transaction documents.  Both the April 11, 2013 note and the June 26, 2013 note were paid off in February 2014.

On May 24, 2013, we entered into a Convertible Redeemable Note.  The lender paid $97,500, net of $2,500 in legal fees, on the closing date.  The note does not bear interest.  The $100,000 principal is due on May 24, 2015.  The Company shall have the right to redeem the note at 120% of the unpaid principal if paid within 90 days of the issuance day, 130% of the unpaid principal if repaid between 91 and 180 days following the issuance day and 150% at any time thereafter. The Company has reserved 1,000,000 shares of common stock for conversion under this note. At any time six months after the closing date, the lender at its option may convert part, or all, of the note then outstanding into shares of the Company’s common stock at a conversion price of 70% of the average weighted average price of the common stock for the 10 trading days preceding the conversion date.  The Company determined that the conversion feature met the definition of a liability and therefore, bifurcated the conversion feature as a derivative liability. The derivative liability is measured at the end of each reporting period and the change in fair value is recorded as other expense or income in the statement of operations.

The proceeds from the convertible debt issued on May 24, 2013, were allocated between the host debt instrument and the convertible option based on the residual method.  The estimated fair value of the convertible option was determined using a binomial formula, resulting in an allocation of $122,223 to the convertible option and accounted for as a liability in the Company’s consolidated balance sheet. In accordance with the provisions of ASC 815-40, the entire gross proceeds of $100,000 is offset by a debt discount of $100,000 which will be amortized to interest expense over the twenty-four month life of the debt. The additional $24,723 adjustment between the convertible option liability and the debt discount was charged directly to other expense.

The entire balance of the debt was repaid on November 22, 2013 and the fair value of the conversion option liability remaining on the balance sheet in the amount of $103,521 was reclassified to additional paid in capital.
 
On June 6, 2013, we signed a convertible debenture in the amount of $500,000.  The lender paid an initial payment of $213,000 net of a “finder’s fee” discount of $25,000 and $12,000 in legal fees, on the closing date.  The lender has the right, any time after six months from the issue date to convert any or part of the outstanding and unpaid principal into shares of the Company’s common stock at a price of $0.40 per share subject to adjustments for stock splits, stock dividends or rights offerings.  The Company has the right to prepay the debenture for a payment of 120% of the outstanding principal plus accrued and unpaid interest.  The Company is required to reserve at least 2.5 times the number of shares actually issuable upon full conversion of this debenture.  The Company determined that the conversion feature met the definition of a liability in accordance with ASC 815-40, since the conversion price was subject to change and the conversion shares were indeterminable, and therefore bifurcated the conversion feature as a derivative liability. The derivative liability is measured at the end of each reporting period and the difference in fair value is recorded as other expense or income in the statement of operations.

The proceeds from the convertible debt issued on June 6, 2013, were allocated between the host debt instrument and the convertible option based on the residual method.  The estimated fair value of the convertible option was determined using a binomial formula, resulting in an allocation of $158,715 to the convertible option and accounted for as a liability in the Company’s consolidated balance sheet. In accordance with the provisions of ASC 815-40, the gross proceeds of $250,000 was offset by a debt discount of $195,715 which will be amortized to interest expense over the twelve month life of the debt.

On December 26, 2013 the Company entered into a settlement agreement with the lender resulting in the Company paying the lender $300,000 in full satisfaction of the original debenture. The conversion option liability remaining on the balance sheet in the amount of $38,180 was reclassified to additional paid in capital.

On August 8, 2013 and October 10, 2013, we received $160,000 and $250,000, respectively in a six-month note from an existing shareholder.  Terms of the note include 18% annual interest, a right to convert the note into the next equity transaction of the Company, at the conversion rate of the equity offering, and a three-year warrant to acquire 160,000 shares of common stock and 250,000 shares of common stock, respectively at $0.40 per share. The relative fair value of the warrants was determined to be $28,722 and $33,824, respectively, which was accounted for as a debt discount and amortized to interest expense over the six-month life of the note. Both of these notes and the accrued interest were converted to our Series K Convertible Preferred Stock on December 12, 2013.

 
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On December 4, 2013, we signed a convertible debenture in the amount of $223,000.  The lender paid an initial payment of $200,000 net of a “original issue” discount of $20,000 and $3,000 in legal fees, on the closing date.  The lender has the right at any time from the issue date to convert all or part of the outstanding and unpaid principal into shares of the Company’s common stock at a price of $0.40 per share subject to adjustments for stock splits, stock dividends or rights offerings.  The Company has the right to prepay the debenture for a payment of 120% of the outstanding principal plus accrued and unpaid interest.  The Company is required to reserve at least 4 times the number of shares actually issuable upon full conversion of this debenture.  The Company determined that the conversion feature met the definition of a liability in accordance with ASC 815-40, since the conversion price was subject to change and the conversion shares were indeterminable, and therefore bifurcated the conversion feature as a derivative liability. The derivative liability is measured at the end of each reporting period and the difference in fair value is recorded as other expense or income in the statement of operations.  The fair value of the conversion feature was $98,129 at December 31, 2013 and reflected in the conversion option liability line in the consolidated balance sheet. In addition the lender received a warrant to purchase 70,000 shares of the Company’s common stock at an exercise price of $0.3125 per share.  The warrants were valued at $11,100 which was allocated to debt discount and will be amortized to interest expense over the twenty-four month life of the debt.

The proceeds from the convertible debt issued on December 4, 2013, were allocated between the host debt instrument and the convertible option based on the residual method.  The estimated fair value of the convertible option was determined using a binomial formula, resulting in an allocation of $90,444 to the convertible option and accounted for as a liability in the Company’s consolidated balance sheet. In accordance with the provisions of ASC 815-40, the gross proceeds of $223,000 was offset by a debt discount of $111,488 which will be amortized to interest expense over the twelve month life of the debt.
 
On December 23, 2013, we signed a convertible debenture in the amount of $150,000.  The lender paid an initial payment of $125,000 net of a “original issue” discount of $15,000 and $10,000 in fees, on the closing date.  The lender has the right, any time from the issue date, to convert any or part of the outstanding and unpaid principal into shares of the Company’s common stock at a price of $0.40 per share subject to adjustments for stock splits, stock dividends or rights offerings.  The Company shall have the right to prepay the debenture for a payment of 120% of the outstanding principal plus accrued and unpaid interest.  The Company is required to reserve at least 3 times the number of shares actually issuable upon full conversion of this debenture.  The Company determined that the conversion feature met the definition of a liability in accordance with ASC 815-40, since the conversion price was subject to change and the conversion shares were indeterminable, and therefore bifurcated the conversion feature as a derivative liability. The derivative liability is measured at the end of each reporting period and the change in fair value is recorded as other expense or income in the statement of operations.  The fair value of the conversion feature was $72,027 at December 31, 2013 and reflected in the conversion option liability line in the consolidated balance sheet. In addition the lender received 75,000 shares of Company restricted common stock, of which the fair value of $17,250 was charged to debt discount and will be amortized to interest expense over the thirty-six month life of the debt.

The proceeds from the convertible debt issued on December 23, 2013, were allocated between the host debt instrument and the convertible option based on the residual method.  The estimated fair value of the convertible option was determined using a binomial formula, resulting in an allocation of $65,003 to the convertible option and accounted for as a liability in the Company’s consolidated balance sheet. In accordance with the provisions of ASC 815-40, the gross proceeds of $150,000 was offset by a debt discount of $102,153 which will be amortized to interest expense over the thirty-six month life of the debt.

Other Notes

On August 23, 2013, we signed a Merchant Agreement with Strategic Funding Source, Inc. (SFS).   Under the agreement we received $75,000 in exchange for rights to all customer receipts until SFS is paid $99,000, to be collected at the rate of $849 per business day. The payments are secured by essentially all tangible assets of the Company. On August 29, 2013 the agreement was modified to give the Company the right to pre-pay the note at any time prior to January 21, 2014; if pre-paid, the Company will receive a discount based on the date of pre-payment after the funding date. Discounts range from $16,500, if pre-paid within 30 days of funding to $1,500, if pre-paid within 150 days of funding. The note was pre-paid on December 10, 2013.

On December 10, 2013, we signed a Merchant Agreement with Scripline LLC.  Under the agreement we received $96,000 in exchange for rights to all customer receipts until Scripline LLC is paid $126,700, to be collected at the rate of $874 per business day. The payments are secured by essentially all tangible assets of the Company. The outstanding balance is recorded as Other debt on the balance sheet.
 
 
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During 2013, loans in the aggregate amount of $1,596,297 were received from lenders under various terms. During the year ended December 31, 2013 $482,011 of these loans have been paid and $565,000 have been converted into the Company’s Convertible Preferred Stock.  The remainder of the loans remain outstanding as of December 31, 2013.
 
(8)   Transactions with Related Persons
 
From time to time Mr. Richard T. Schumacher, the Company’s President and CEO, makes loans to the Company to provide the Company with operating cash. The balance of these loans at December 31, 2013 was $25,182 and is recorded as related party debt in the accompanying consolidated balance sheet as of December 31, 2013.
 
On February 6, 2013, Mr. Schumacher invested $25,200 in our Series J Offering of Convertible Preferred Stock and warrants to purchase shares of Common Stock, for 63 shares of convertible Preferred Stock (convertible into 63,000 shares of Common Stock) and a Warrant to purchase 63,000 shares of Common Stock at an exercise price of $0..40 per share.
 
On February 6, 2013, Mr. Jeffrey Peterson, chairman of the Company’s Board of Directors, invested $25,508 of existing loans and interest and $7,292 in board of director fees in our Series J Private Placement of Convertible Preferred Stock and warrants to purchase shares of Common Stock, for 82 shares of convertible Preferred Stock (convertible into 82,000 shares of Common Stock) and a Warrant to purchase 82,000 shares of Common Stock at an exercise price of $0.40 per share.
 
On February 6, 2013, Mr. Vito Mangiardi, member of the Company’s Board of Directors, invested $25,000 in cash and $4,167 in board of director fees  in our Series J Private Placement of Convertible Preferred Stock and warrants to purchase shares of Common Stock, for 73 shares of convertible Preferred Stock (convertible into 73,000 shares of Common Stock) and a Warrant to purchase 73,000 shares of Common Stock at an exercise price of $0.40 per share.
 
On February 6, 2013, Mr. Kevin Pollack member of the Company’s Board of Directors, invested $15,000 in cash, $25,233 in existing loans and $4,167 in board of directors fees in our Series J Offering of Convertible Preferred Stock and warrants to purchase shares of Common Stock, for 111 shares of convertible Preferred Stock (convertible into 111,000 shares of Common Stock) and a Warrant to purchase 111,000 shares of Common Stock at an exercise price of $0.40 per share.
 
On February 6, 2013, Dr. Mickey Urdea member of the Company’s Board of Directors, invested $22,500 in board of director fees, in our Series J Offering of Convertible Preferred Stock and warrants to purchase shares of Common Stock, for 57 shares of convertible Preferred Stock (convertible into 57,000 shares of Common Stock) and a Warrant to purchase 57,000 shares of Common Stock at an exercise price of $0.40 per share.
 
 On December 12, 2013, Mr. Schumacher invested $30,335 in our Series K Offering of Convertible Preferred Stock and warrants to purchase shares of Common Stock, for 122 shares of convertible Preferred Stock (convertible into 122,000 shares of Common Stock) and a Warrant to purchase 61,000 shares of Common Stock at an exercise price of $0.3125 per share.
 
On December 12, 2013, Mr. Jeffrey Peterson, invested $25,875 in our Series K Offering of Convertible Preferred Stock and warrants to purchase shares of Common Stock, for 103 shares of convertible Preferred Stock (convertible into 103,000 shares of Common Stock) and a Warrant to purchase 51,500 shares of Common Stock at an exercise price of $0..3125 per share.
 
On December 12, 2013, Mr. Vito Mangiardi, invested $22,500 in our Series K Offering of Convertible Preferred Stock and warrants to purchase shares of Comon Stock, for 90 shares of convertible Preferred Stock (convertible into 90,000 shares of Common Stock) and a Warrant to purchase 45,000 shares of Common Stock at an exercise price of $0.3125 per share.
 
On December 12, 2013, Mr. Kevin Pollack, invested $22,500 in our Series K Offering of Convertible Preferred Stock and warrants to purchase shares of Common Stock, for 90 shares of convertible Preferred Stock (convertible into 90,000 shares of Common Stock) and a Warrant to purchase 45,000 shares of Common Stock at an exercise price of $0.3125 per share.
 
On December 12, 2013, Dr. Mickey Urdea, invested $32,500 in our Series K Offering of Convertible Preferred Stock and warrants to purchase shares of Common Stock, for 130 shares of convertible Preferred Stock (convertible into 130,000 shares of Common Stock) and a Warrant to purchase 65,000 shares of Common Stock at an exercise price of $0.3125 per share.
 
 
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(9)  Stockholders’ (Deficit)

Preferred Stock

We are authorized to issue 1,000,000 shares of preferred stock with a par value of $0.01. Of the 1,000,000 shares of preferred stock:

1)  
  20,000 shares have been designated as Series A Junior Participating Preferred Stock (“Junior A”)
2)  
 313,960 shares have been designated as Series A Convertible Preferred Stock (“Series A”)
3)  
 279,256 shares have been designated as Series B Convertible Preferred Stock (“Series B”)
4)  
   88,098 shares have been designated as Series C Convertible Preferred Stock (“Series C”)
5)  
        850 shares have been designated as Series D Convertible Preferred Stock (“Series D”)
6)  
        500 shares have been designated as Series E Convertible Preferred Stock (“Series E”)
7)  
 240,000 shares have been designated as Series G Convertible Preferred Stock (“Series G”)
8)  
   10,000 shares have been designated as Series H Convertible Preferred Stock (“Series H”)
9)  
   6,250 shares have been designated as Series J Convertible Preferred Stock (“Series J”)
10)  
   15,000 shares have been designated as Series K Convertible Preferred Stock (“Series K”)
 
As of December 31, 2013, there were no shares of Junior A, and Series A, B, C, E, and H issued and outstanding.

Series A Convertible Preferred Stock

On February 12, 2009, we completed a private placement, pursuant to which we sold an aggregate of 156,980 units (the “Series A Units”) for a purchase price of $11.50 per unit (the “Series A Purchase Price”), resulting in gross proceeds to us of $1,805,270 (the “Series A Private Placement”). Each Series A Unit consisted of (i) one share of Series A Convertible Preferred Stock convertible into 10 shares of our Common Stock, (ii) a warrant to purchase one share of Series A Convertible Preferred Stock at an exercise price equal to $12.50 per share, with a term expiring 15 months after the date of closing (“15-Month Series A Preferred Stock Warrant”); and (iii) a warrant to purchase 10 shares of  Common Stock at an exercise price equal to $2.00 per share, with a term expiring 30 months after the date of closing (the “30-Month  Common Stock Warrants”).

As a result of the issuance of Common Stock in connection with dividends paid on the Series A Preferred Stock and the Series B Preferred Stock, the exercise price of the 30-Month Common Stock Warrants has been adjusted from $2.00 to $1.72 in accordance with the terms of the 30-Month Common Stock Purchase Warrants.

On or about August 10, 2011, holders of 30-Month Common Stock Warrants to purchase 1,569,800 shares of Common Stock entered into an amendment to the 30-Month Common Stock Warrants which extended the expiration date of the warrants to August 11, 2012. On or about September 30, 2011, 30-Month Common Stock Warrants to purchase 1,556,750 shares of Common Stock were further amended to reduce the exercise price from $1.74 to $0.90 and to extend the term until August 12, 2016 and, with respect to affiliates, August 12, 2015. A 30-Month Common Stock Warrant to purchase 13,050 shares of Common Stock was not amended and was further adjusted by Common Stock dividends issued in October 2011 resulting in an effective exercise price of $1.72 per share, subject to future adjustment, with a term expiring on August 11, 2012.

Each share of Series A Convertible Preferred Stock received a cumulative dividend at the rate of 5% per annum of the Series A Purchase Price, payable semi-annually on June 30 and December 31, commencing on June 30, 2009 (with the first payment being pro-rated based on the number of days occurring between the date of issuance and June 30, 2009). The Company was permitted to pay dividends in cash or in shares of Common Stock at our option, subject to certain conditions.. The Board approved the final payment to Series A holders in the form of Common Stock for accrued dividends through September 30, 2011.

On or about September 30, 2011, all 47 holders of both the outstanding Series A Convertible Preferred Stock and Series A 30-Month Common Stock Purchase Warrants, issued in the Series A Convertible Preferred Stock financing completed by the Company in February 2009, voluntarily converted an aggregate of 247,187 shares of Series A Preferred Stock into 2,471,870 shares of the Company’s Common Stock.
 
 
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Series B Convertible Preferred Stock

On November 18, 2009, we sold an aggregate of 62,039 units (the “Series B Units”) for a purchase price of $18.80 per unit (the “Series B Purchase Price”), resulting in gross proceeds to us of $1,166,333. This was the first tranche of a $2.5 million private placement. The second tranche closed on March 18, 2010 for the sale of 26,672 Series B Units with gross proceeds of $501,434 (collectively the two tranches are referred to as the “Series B Private Placements”). Each Series B Unit consisted of (i) one share of Series B Convertible Preferred Stock convertible into 10 shares of our Common Stock and (ii) a warrant to purchase one share of Series B Convertible Preferred Stock at an exercise price equal to $23.80 per share for warrants issued in November 2009 and at an exercise price of $28.80 for warrants issued in March 2010, in each case with a term expiring on August 11, 2011 (the “Series B Warrant”).
 
 
On or about August 10, 2011, holders of the Series B Warrants to purchase 887,110 shares of Common Stock entered into an amendment to the Series B Warrants which extended the expiration date of the Series B Warrants to August 11, 2012 and provided that they would be issuable for the equivalent number of shares of Common Stock at a proportionate exercise price. On or about September 30, 2011, Series B Warrants to purchase 887,110 shares of Common Stock were further amended to reduce the exercise price from $2.38 to $1.43, for Series B Warrants issued in November 2009, and from $2.88 to $1.75, for Series B Warrants issued in March 2010. Series B Warrants also extended the term of the Series B Warrants until August 12, 2016 and until August 12, 2015 with respect to affiliates. All of the Series B Warrants are no longer exercisable for shares of Series B Convertible Preferred Stock.

On or about September 30, 2011, all of the outstanding shares of Series B Convertible Preferred Stock were voluntarily converted into shares of Common Stock.

Each share of Series B Convertible Preferred Stock received a cumulative dividend at the rate of 5% per annum of the Series B Purchase Price, payable semi-annually on June 30 and December 31, commencing on December 31, 2009 (with the first payment being pro-rated based on the number of days occurring between the date of issuance and December 31, 2009). The Company was permitted to pay dividends in cash or in shares of Common Stock at our option, subject to certain conditions. The shares of Series B Convertible Preferred Stock were also entitled to a liquidation preference, such that in the event of any voluntary or involuntary liquidation, dissolution or winding up of our Company, the holders of Series B Convertible Preferred Stock would have been paid out of the assets of the Company available for distribution to our stockholders before any payment was paid to the holders of  Common Stock, an amount per share equal to the Series B Purchase Price, plus accrued and unpaid dividends. The Series B Convertible Preferred Stock would have been treated on an equivalent basis with the holders of the Series A Convertible Preferred Stock and Series C Convertible Preferred Stock with respect to payments made in connection with a liquidation. The Board approved the method of payment in the form of Common Stock for the dividends payable with respect to December 31, 2009 and the June 30, 2010 (to the holders of Series B Convertible Preferred Stock issued in November 2009). The Board approved the method of payment in the form of cash for the dividends payable with respect to June 30, 2010 (to the holders of Series B Convertible Preferred Stock issued in March 2010), December 31, 2010 and for all dividends accrued through December 31, 2012.

Each share of Series B Convertible Preferred Stock was convertible into 10 shares of Common Stock at any time at the option of the holder, subject to adjustment for stock splits, stock dividends, recapitalizations and similar transactions (the “Series B Conversion Ratio”). Each share of Series B Convertible Preferred Stock would have been automatically converted into shares of  Common Stock at the Series B Conversion Ratio then in effect: (i) if, after 12 months from the closing of the applicable tranche of the Series B Private Placement, the  Common Stock traded on the OTC Market (or other primary trading market or exchange on which the  Common Stock was then traded) at a price equal $5.64 for 20 out of 30 consecutive trading days with average daily trading volume of at least 10,000 shares; or (ii) upon a registered public offering by the Company at a per share price equal to $5.64, with aggregate gross proceeds to the Company of not less than $10 million. Unless waived under certain circumstances by the holder of the Series B Convertible Preferred Stock, such holder’s Series B Convertible Preferred Stock could not have been converted if upon such conversion the holder’s beneficial ownership would exceed certain thresholds.
 
Series B Warrants
 
The Series B Warrants issued in November 2009 originally had an exercise price equal to $23.80 and the Series B Warrants issued in March 2010 originally had an exercise price equal to $28.80, in each case with a term expiring on August 11, 2011. The Series B Warrants currently have an exercise price of $1.43 for Series B Warrants issued in November 2009, and $1.75 for Series B Warrants issued in March 2010, in each case with a term expiring on August 12, 2016 and, with respect to affiliates, August 12, 2015. The Series B Warrants are currently exercisable for shares of Common Stock. The Series B Warrants permit the holder to conduct a “cashless exercise” at any time the holder of the Series B Warrant is an “affiliate” (as defined in the Securities Purchase Agreement) of the Company.

 
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Series C Convertible Preferred Stock

On April 8, 2011 and April 12, 2011, we completed the first tranche of a private placement, pursuant to which we sold an aggregate of 55,048 units for a purchase price of $15.00 per unit, resulting in gross proceeds to us of $825,720 (the “Series C Private Placement”). This was the first tranche of the Series C Private Placement. In connection with the second tranche, the purchase price was reduced to $12.50 per unit and we issued an additional 11,011 units to the purchasers who participated in the first tranche, without any additional gross proceeds to us.

The second tranche closed on June 20, 2011 for the sale of 22,039 Series C Units (as defined below) for a purchase price of $12.50 per unit with gross proceeds of $275,485. Each unit (“Series C Unit”) consisted of (i) one share of Series C Convertible Preferred Stock, $0.01 par value per share (the “Series C Convertible Preferred Stock”) convertible into 10 shares of our  Common Stock, (subject to adjustment for stock splits, stock dividends, recapitalization, etc.); and (ii) a three-year warrant to purchase 10 shares of our  Common Stock at a per share exercise price equal to the sum of (i) the  Common Stock equivalent of the Series C Purchase Price (ii) plus $0.88 (the “Series C Warrant”). The Series C Warrants are exercisable until the close of business on the third anniversary of the applicable closing date.

We engaged an investment banker (the “Investment Banker”) to assist with the Series C Private Placement. The Company paid the Investment Banker a cash retainer fee of $50,000 and issued a warrant to the Investment Banker to purchase 100,000 shares of Common Stock at an exercise price of $3.00 per share. In connection with the Series C Private Placement, we paid the Investment Banker a fee of (i) approximately $66,000 cash, (ii) an expense allowance of approximately $16,500, (iii) a warrant to purchase 61,638 shares of Common Stock exercisable at a purchase price of $1.50, and (iv) a warrant to purchase 61,638 shares of Common Stock exercisable at a purchase price of $2.38.

The proceeds from the sale of each Series C Unit were allocated between the Series C Convertible Preferred Stock and the Series C Warrants based on the residual method. The estimated fair value of the Series C Warrants was determined using a binomial formula, resulting in an allocation of the gross proceeds of $583,250 to the total warrants issued. The allocation of the gross proceeds to the Series C Convertible Preferred Stock was $517,958. In accordance with the provisions of ASC 470-20, an additional adjustment between Additional Paid in Capital and Accumulated Deficit of $476,434 was recorded to reflect an implicit non-cash dividend related to the allocation of proceeds between the stock and warrants issued. The $476,434 represents the value of the adjustment to additional paid in capital related to the beneficial conversion feature of the Series C Convertible Preferred Stock. The value adjustment was calculated by subtracting the fair market value of the underlying Common Stock on April 7 and June 20 issuable upon conversion of the Series C Convertible Preferred Stock from the fair market value of the Series C Convertible Preferred Stock as determined when the Company performed a fair market value allocation of the proceeds to the Series C Convertible Preferred Stock and warrants. We used a binomial formula since the warrants have down-round protection and are recorded as a liability. See “Warrant Derivative Liability” section within this note.

Each share of Series C Convertible Preferred Stock will receive a cumulative dividend at the rate of 5% per annum of the respective tranche purchase price, payable semi-annually on June 30 and December 31, commencing on June 30, 2011 with the first payment being pro-rated based on the number of days occurring between the date of issuance and June 30, 2011. Dividends may be paid in cash or in shares of Common Stock at our option, subject to certain conditions. The shares of Series C Convertible Preferred Stock also are entitled to a liquidation preference, such that in the event of any voluntary or involuntary liquidation, dissolution or winding up of our Company, the holders of Series C Convertible Preferred Stock will be paid out of the assets of the Company available for distribution to our stockholders before any payment shall be paid to the holders of  Common Stock, an amount per share equal to the Series C Purchase Price, plus accrued and unpaid dividends. Prior to the conversion of all of the outstanding shares of Series A Convertible Preferred Stock and Series B Convertible Preferred Stock, the Series C Convertible Preferred Stock was treated on an equivalent basis with the Series A Convertible Preferred Stock and Series C Preferred Stock with respect to payments made in connection with a liquidation. The Company elected to pay the dividend payable on June 30, 2011 in cash.

Each share of Series C Convertible Preferred Stock is convertible into 10 shares of Common Stock at any time at the option of the holder, subject to adjustment for stock splits, stock dividends, recapitalizations and similar transactions (the “Series C Conversion Ratio”). Each share of Series C Convertible Preferred Stock will automatically be converted into shares of  Common Stock at the Series C Conversion Ratio then in effect: (i) if, after 12 months from the closing of the applicable tranche of the Series C Private Placement, the  Common Stock trades on the OTC Market, or other primary trading market or exchange on which the  Common Stock is then traded, at a price equal to three-tenths of the Series C Unit purchase price for 20 out of 30 consecutive trading days with average daily trading volume of at least 10,000 shares or (ii) upon a registered public offering by the Company at a per share price equal to at least three-tenths of the Series C Unit purchase price, with aggregate gross proceeds to the Company of not less than $10 million. Unless waived under certain circumstances by the holder of the Series C Convertible Preferred Stock, such holder’s Series C Convertible Preferred Stock may not be converted if upon such conversion the holder’s beneficial ownership would exceed certain thresholds.

 
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The holders of Series C Convertible Preferred Stock are not entitled to vote on any matters presented to the stockholders of the Company for their action or consideration at any meeting of stockholders of the Company, or by written consent of stockholders in lieu of meeting, except that the holders of Series C Convertible Preferred Stock may vote separately as a class on any matters that would amend, alter or repeal any provision of our Restated Articles of Organization, as amended, in a manner that adversely affects the powers, preferences or rights of the Series C Convertible Preferred Stock and such holders may also vote on any matters required by law.

If we consummate an equity financing (other than the exercise of employee stock options under the Company’s stock option plans, the Series C Private Placement or the exercise of any Series C Warrants, or the exercise or conversion of any currently outstanding  Common Stock equivalents) within twelve months after the initial Closing and the gross proceeds to the Company from the sale of the Units are less than $4 million, then each holder of Series C Units may exchange all, but not less than all, of his, her or its Series C Units for the equity securities issued in such next financing and shall become subject to the terms and conditions of such next financing; provided that the exchange of the purchaser’s Series C Units for next financing securities is permitted under the rules and regulations of the NASDAQ Trading Market then in effect. The number of next financing securities into which a purchaser’s Series C Units may be exchanged shall be determined by dividing (a) the aggregate per unit purchase price at which the Series C Units being exchanged were issued, by (b) the price per next financing security at which such securities were issued in the next financing. The requisite holders of the Series C Units waived such right with respect to the Company’s recently completed equity financing. At any time after February 12, 2014, upon 30 days written notice, we have the right to redeem the outstanding shares of Series C Convertible Preferred Stock at a price equal to the Series C Unit purchase price, plus all accrued and unpaid dividends thereon. The redemption price may be paid in two annual installments. All holders of Series C Convertible Preferred Stock will be treated on an equivalent basis with respect to payments made in connection with redemption.

Series C Warrants
 
The Series C Warrants have an exercise price equal to $2.13 with a term expiring on the third anniversary of the deal closing. The Series C Warrants permit the holder to conduct a “cashless exercise” at any time the holder of the Series C Warrant is an “affiliate” (as defined in the Securities Purchase Agreement) of the Company.

The Series C Warrant exercise price and/or number of shares issuable upon exercise of the Series C Warrant will be subject to adjustment for stock dividends, stock splits or similar capital reorganizations, as set forth in the Series C Warrants.

Subject to the terms and conditions of the Series C Warrants, the Company has the right to call for cancellation the Series C Warrants if the volume weighted average price of our Common Stock on the OTC Market (or other primary trading market or exchange on which our Common Stock is then traded) equals or exceeds two times the per common share exercise price for either (i) 10 consecutive trading days or (ii) 15 out of 25 consecutive trading days.

On April 5, 2012, all 11 holders of outstanding Series C Convertible Preferred Stock and Series C Common Stock Purchase Warrants voluntarily converted an aggregate of 88,098 shares of Series C Preferred Stock into 1,372,247 shares of the Company’s Common Stock, and Series C Warrants to purchase an aggregate of 880,980 shares of the Company’s Common Stock to warrants to purchase 686,125 shares of Common Stock in the Company.

Series D Convertible Preferred Stock

On November 11, 2011, we completed a registered direct offering, pursuant to which we sold an aggregate of 843 units for a purchase price of $1,000 per unit, resulting in gross proceeds to us of $843,000 (the “Series D Placement”). Each unit (“Series D Unit”) consisted of (i) one share of Series D Convertible Preferred Stock, $0.01 par value per share (the “Series D Convertible Preferred Stock”) convertible into 1,538.46 shares of our  Common Stock, (subject to adjustment for stock splits, stock dividends, recapitalization, etc.) and (ii) one five-year warrant to purchase approximately 614 shares of our  Common Stock at a per share exercise price of $0.81, subject to adjustment as provided in the Warrants (“Series D Warrant”). The Series D Warrants will be exercisable beginning on May 11, 2012 and until the close of business on the fifth anniversary of the initial exercise date.

 
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We engaged an investment banker to assist with the Series D Placement. In connection with the Series D Placement, we paid the investment banker a fee of approximately $67,000 cash.

The proceeds from the sale of each Series D Unit were allocated between the Series D Convertible Preferred Stock and the Series D Warrants based on the residual method. The estimated fair value of the Series D Warrants was determined using a binomial formula, resulting in an allocation of the gross proceeds of $283,725 to the total warrants issued. The allocation of the gross proceeds to the Series D Convertible Preferred Stock was $559,275. In accordance with the provisions of ASC 470-20, an additional adjustment between Additional Paid in Capital and Accumulated Deficit of $530,140 was recorded to reflect an implicit non-cash dividend related to the allocation of proceeds between the stock and warrants issued. The $530,140 represents the value of the adjustment to additional paid in capital related to the beneficial conversion feature of the Series D Convertible Preferred Stock. The value adjustment was calculated by subtracting the fair market value of the underlying Common Stock on November 10, 2011 issuable upon conversion of the Series D Convertible Preferred Stock from the fair market value of the Series D Convertible Preferred Stock as determined when the Company performed a fair market value allocation of the proceeds to the Series D Convertible Preferred Stock and warrants. The warrants are recorded as a liability. See “Warrant Derivative Liability” below.

The Series D Convertible Preferred Stock will rank senior to the Company’s Common Stock and Series C Convertible Preferred Stock with respect to payments made upon liquidation, winding up or dissolution. Upon any liquidation, dissolution or winding up of the Company, after payment of the Company’s debts and liabilities, and before any payment is made to the holders of any junior securities, the holders of Series D Convertible Preferred Stock will first be entitled to be paid $1,000 per share subject to adjustment for accrued but unpaid dividends.

We may not pay any dividends on shares of Common Stock unless we also pay dividends on the Series D Convertible Preferred Stock in the same form and amount, on an as-if-converted basis, as dividends actually paid on shares of our Common Stock. Except for such dividends, no other dividends may be paid on the Series D Convertible Preferred Stock.

Each share of Series D Convertible Preferred Stock is convertible into 1,538.46 shares of  Common Stock (based upon an initial conversion price of $0.65 per share) at any time at the option of the holder, subject to adjustment for stock splits, stock dividends, combinations, and similar recapitalization transactions (the “Series D Conversion Ratio”). Subject to certain exceptions, if the Company issues any shares of  Common Stock or  Common Stock equivalents at a per share price that is lower than the conversion price of the Series D Convertible Preferred Stock, the conversion price will be reduced to the per share price at which such shares of  Common Stock or Common Stock equivalents are issued. Each share of Series D Convertible Preferred Stock will automatically be converted into shares of  Common Stock at the Series D Conversion Ratio then in effect if, after six months from the closing of the Series D Placement, the  Common Stock trades on the OTC Market (or other primary trading market or exchange on which the  Common Stock is then traded) at a price equal to at least 300% of the then effective Series D Convertible Preferred Stock conversion price for 20 out of 30 consecutive trading days with each trading day having a volume of at least $50,000. Unless waived under certain circumstances by the holder of the Series D Convertible Preferred Stock, such holder’s Series D Convertible Preferred Stock may not be converted if upon such conversion the holder’s beneficial ownership would exceed certain thresholds.

In addition, in the event we consummate a merger or consolidation with or into another person or other reorganization event in which our shares of  Common Stock are converted or exchanged for securities, cash or other property, or we sell, lease, license or otherwise dispose of all or substantially all of our assets or we or another person acquire 50% or more of our outstanding shares of  Common Stock, then following such event, the holders of the Series D Convertible Preferred Stock will be entitled to receive upon conversion of the Series D Convertible Preferred Stock the same kind and amount of securities, cash or property which the holders of the Series D Convertible Preferred Stock would have received had they converted the Series D Convertible Preferred Stock immediately prior to such fundamental transaction.

The holders of Series D Convertible Preferred Stock are not entitled to vote on any matters presented to the stockholders of the Company for their action or consideration at any meeting of stockholders of the Company (or by written consent of stockholders in lieu of meeting), except that the holders of Series D Convertible Preferred Stock may vote separately as a class on any matters that would (i) amend, our Restated Articles of Organization, as amended, in a manner that adversely affects the rights of the Series D Convertible Preferred Stock, (ii) alter or change adversely the powers, preferences or rights of the Series D Convertible Preferred Stock or alter or amend the certificate of designation, (iii) authorize or create any class of shares ranking as to dividends, redemption or distribution of assets upon liquidation senior to, or otherwise pari passu with, the Series D Convertible Preferred Stock, or (iv) increase the number of authorized shares of Series D Convertible Preferred Stock.

 
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If, within 12 months of the initial issuance of the Series D Convertible Preferred Stock, we issue any  Common Stock,  Common Stock equivalents, indebtedness or any combination thereof (a “Subsequent Financing”), the holders of Series D Convertible Preferred Stock will have the right to participate on a pro-rata basis in up to 50% of such Subsequent Financing.

During the year ended December 31, 2012, 443 shares of Series D Convertible Preferred Stock were converted to 681,538 shares of Common Stock.

        Series D Warrants
 
The Series D Warrants originally had an exercise price equal to $0.81 per share of common stock. The number of Series D Warrants increased by 530,406 to a total of 1,047,875 and each Series D Warrant currently has an exercise price equal to $0.40 per share of common stock. These adjustments were made in connection with our April 2012 registered direct offering in accordance with the Series D Warrant. The Series D Warrant are exercisable beginning on the six-month anniversary of the date of issuance and expire five years from the initial exercise date. The Series D Warrants permit the holder to conduct a "cashless exercise" at any time a registration statement, or the prospectus contained herein, is not available for the issuance of shares of common stock issuable upon exericise of the Series D Warrant, and under certain circumstances at the expiration of the Series D Warrants. The exericise price and/or number of shares of common stock issuable upon exercise of the Series D Warrants are subject to adjustment for certain stock dividends, stock splits or similar capital reorganizations, as set forth in the Warrants. The exercise price and/or number of shares of common stock issuable upon exercise of the Series D Warrants are also subject to adjustment in the event that we issue any shares of common stock or common stock equivalents at a per share price that is lower than the exercise price for the Series D Warrants then in effect. Upon any such issuance, subject to certain exceptions, the exercise price will be reduced to the per share price at which such shares of common stock or common stock equivalents are issued and number of Series D Warrant shares issuable thereunder shall be increased such that the aggregate exercise price payable thereunder, after taking into account the decrease in the exercise price, shall be equal to the aggregate exercise price prior to such adjustment. Unless waived under certain circumstance by the holder of a Series D Warrant, such holder may not exercise the Series D Warrant if upon such exercise the holder's beneficial ownership of the Company's common stock would exceed certain thresholds. 
 
In the event we consummate a merger or consolidation with or into another person or other reorganization event in which our shares of  Common Stock are converted or exchanged for securities, cash or other property, or we sell, lease, license or otherwise dispose of all or substantially all of our assets or we or another person acquire 50% or more of our outstanding shares of  Common Stock, then following such event, the holders of the Series D Warrants will be entitled to receive upon exercise of the Series D Warrants the same kind and amount of securities, cash or property which the holders would have received had they exercised the Series D Warrants immediately prior to such fundamental transaction.

Series E Convertible Preferred Stock

On April 9, 2012, we completed a registered direct offering with Ironridge Global IV Ltd. (“Ironridge”), pursuant to which we sold an aggregate of 500 shares of our Series E Convertible Preferred Stock to Ironridge for a purchase price of $1,000 per share or an aggregate purchase price of $500,000 (“Series E Preferred Stock”). Each share of Series E Preferred Stock was convertible into approximately 980 shares of our Common Stock. The Series E Preferred Stock was entitled to a yearly dividend at a rate of 10.5% per year, subject to a credit risk and make-whole adjustment, and was payable in cash or shares of Common Stock at our election. Under certain conditions and subject to certain limitations, we could have required Ironridge to convert their Series E Convertible Preferred Stock into Common Stock.  In connection with this registered direct offering, our investment banker received a fee of $40,000. The make-whole dividends were payable any time after the closing on April 9, 2012 at the option of the holder; therefore, we recognized the full value of $262,500 as a current liability and charged this amount immediately to accumulated deficit. We adjusted the value as of September 30, 2012 based on the closing bid on September 28, 2012. We paid $128,402 of make-whole dividends in the Company’s Common Stock and $67,500 in cash.  Ironridge converted all 500 shares of Series E Preferred Stock into 490,196 common shares in 2012.

The Series E Preferred Stock ranked senior to the Company’s Common Stock for so long as at least 250 shares of Series E Preferred Stock remained outstanding and pari passu thereafter and junior to the Series D Preferred Stock with respect to payments made upon liquidation, winding up or dissolution. Upon any liquidation, dissolution or winding up of the Company, after payment of the Company’s debts and liabilities, and before any payment was made to the holders of any junior securities, the holders of Series E Convertible Preferred Stock were first entitled to be paid $1,000 per share subject to adjustment for accrued but unpaid dividends.

 
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We were not allowed to pay any dividends on shares of Common Stock so long as any shares of Series E Preferred Stock were outstanding.

Each share of Series E Preferred Stock was convertible into 980.39 shares of  Common Stock (based upon an initial conversion price of $1.02 per share) at any time at the option of the holder, subject to adjustment for stock splits, stock dividends, combinations, and similar recapitalization transactions (the “Series E Conversion Ratio”). At our option, each share of Series E Preferred Stock could have been converted into shares of  Common Stock at the Series E Conversion Ratio then in effect if, the  Common Stock trades on the OTC Capital Market (or other primary trading market or exchange on which the  Common Stock was then traded) at a price equal to at least $2.00 for 20 out of 25 consecutive trading days. Unless waived under certain circumstances by the holder of the Series E Preferred Stock, such holder’s Series E Preferred Stock may not have been converted if upon such conversion the holder’s beneficial ownership would exceed certain thresholds.

Subject to the rights of the holders of Series D Preferred Stock, for so long as at least 250 shares of Series E Preferred Stock remained outstanding, upon any liquidation, dissolution or winding up of the Company, whether voluntary or involuntary (each a “Liquidation Event”), after payment or provision for payment of debts and other liabilities of the Company, the holders of Series E Preferred Stock would have been entitled to be paid out of the assets of the Company available for distribution to its stockholders an amount with respect to each share of Series E Preferred Stock equal to $1,000, plus any accrued but unpaid dividends thereon (the “Series E Liquidation Value”), before any distribution or payment would have been made to the holders of  Common Stock. Subject to the rights of the holders of Series D Preferred Stock, at any time that fewer than 250 shares of Series E Preferred Stock remained outstanding, upon the occurrence of any Liquidation Event, after payment or provision for payment of debts and other liabilities of the Company, pari passu with any distribution or payment made to the holders of  Common Stock by reason of their ownership thereof, the holders of Series E Preferred Stock would have been entitled to be paid out of the assets of the Company available for distribution to its stockholders the Series E Liquidation Value. For so long as at least 250 shares of Series E Preferred Stock remained outstanding, if, upon the occurrence of any Liquidation Event, the amounts payable with respect to the shares of Series E Preferred Stock are not paid in full, the holders of shares of Series E Preferred Stock would have shared equally and ratably with each other in any distribution of assets of the Company in proportion to the Series E Liquidation Value, if any, to which each such holder was entitled, before any distribution or payment shall have been made to holders of  Common Stock. At any time that fewer than 250 shares of Series E Preferred Stock remained outstanding, if, upon the occurrence of any Liquidation Event, the amounts payable with respect to the shares of Series E Preferred Stock were not paid in full, the holders of shares of Series E Preferred Stock would have received the Series E Liquidation Value per share of Series E Preferred Stock on a proportionate and pari passu basis with the holders of Common Stock.

The holders of Series E Preferred Stock were not entitled to vote on any matters presented to the stockholders of the Company for their action or consideration at any meeting of stockholders of the Company (or by written consent of stockholders in lieu of meeting), except that the holders of Series E Preferred Stock may have voted separately as a class on any matters that would (i) amend our Restated Articles of Organization, as amended, in a manner that adversely affects the rights of the Series E Preferred Stock, (ii) alter or change adversely the powers, preferences or rights of the Series E Preferred Stock or alter or amend the certificate of designation, (iii) authorize or create any class of shares ranking as to dividends, redemption or distribution of assets upon liquidation senior to, or otherwise pari passu with, the Series E Preferred Stock, or (iv) increase the number of authorized shares of Series E Preferred Stock.

No shares of Series E Convertible Preferred Stock remained outstanding as of December 31, 2012.

Series G Convertible Preferred Stock

On July 6 and November 15, 2012, we completed a private placement, pursuant to which we sold an aggregate of 145,320 units for a purchase price of $5.00 per unit (the “Series G Purchase Price”), resulting in gross proceeds to us of $726,600 (the “Series G Private Placement”). Each unit (“Series G Unit”) consists of (i) one share of Series G Convertible Preferred Stock, $0.01 par value per share (the “Series G Preferred Stock”) convertible into 10 shares of our Common Stock, (subject to adjustment for stock splits, stock dividends, recapitalization, etc.) and (ii) a three-year warrant to purchase 5 shares of our Common Stock at a per share exercise price of $0.50 (the “Series G Warrant”). The Series G Warrants will be exercisable until the close of business on the third anniversary of the applicable closing date of the Series G Private Placement. Of the $726,600 invested in the Series G Private Placement, $31,100 was received in cash and $695,500 was from the conversion of outstanding indebtedness and accrued board of directors’ fees.

Each share of Series G Preferred Stock will receive a cumulative dividend at the annual rate of (i) four percent (4%) on those shares of Series G Preferred Stock purchased from the Company by an individual purchaser with an aggregate investment of less than $100,000, (ii) six percent (6%) on those shares of Series G Preferred Stock purchased from the Company by an individual purchaser with an aggregate investment of at least $100,000 but less than $250,000, and (iii) twelve percent (12%) on those shares of Series G Preferred Stock purchased from the Company by an individual purchaser with an aggregate investment of at least $250,000. Dividends accruing on the Series G Preferred Stock shall accrue from day to day until, and shall be paid within fifteen (15) days of, the first anniversary of, the original issue date of the Series G Preferred Stock; provided, however, if any shares of the Company’s Series E Preferred Stock are outstanding at such time, payment of the accrued dividends on the Series G Preferred Stock shall be deferred until no such shares of Series E Convertible Preferred Stock remain outstanding. The Company may pay accrued dividends on the Series G Preferred Stock in cash or in shares of its Common Stock equal to the volume weighted average price of the Common Stock as reported by the OTC QB Market for the ten (10) trading days immediately preceding the Series G’s first anniversary.

 
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At the election of the Company and upon required advanced notice, each share of Series G Preferred Stock will automatically be converted into shares of  Common Stock at the Conversion Ratio then in effect: (i) if, after 6 months from the original issuance date of the Series G Preferred Stock, the  Common Stock trades on the OTC QB Market (or other primary trading market or exchange on which the  Common Stock is then traded) at a price equal to at least $0.75, for 7 out of 10 consecutive trading days with average daily trading volume of at least 10,000 shares, (ii) on or after the first anniversary of the original issuance date of the Series G Preferred Stock or (iii) upon completion of a firm-commitment underwritten registered public offering by the Company at a per share price equal to at least $0.75, with aggregate gross proceeds to the Company of not less than $2.5 million. Unless waived under certain circumstances by the holder of the Series G Preferred Stock, such holder’s Series G Preferred Stock may not be converted if upon such conversion the holder’s beneficial ownership would exceed certain thresholds.

The holders of Series G Preferred Stock are not entitled to vote on any matters presented to the stockholders of the Company for their action or consideration at any meeting of stockholders of the Company (or by written consent of stockholders in lieu of meeting), except as required by law.

Series G Warrants
 
 
The Series G Warrants issued in the Series G Private Placement have an exercise price equal to $0.50 per share, with a term expiring on July 6, 2015. The Series G Warrants also permit the holder to conduct a “cashless exercise” at any time the holder of the Series G Warrant is an affiliate of the Company. The exercise price and/or number of shares issuable upon exercise of the Series G Warrants will be subject to adjustment for stock dividends, stock splits or similar capital reorganizations, as set forth in the Series G Warrants.

Subject to the terms and conditions of the Series G Warrants, at any time commencing six months from the closing date the Company has the right to call for cancellation of the Series G Warrants if the volume weighted average price of its  Common Stock on the OTC QB Market (or other primary trading market or exchange on which our  Common Stock is then traded) equals or exceeds three times the per share exercise price of the Warrants for either (i) 10 consecutive trading days or (ii) 15 out of 25 consecutive trading days.

In connection with our sale of Series G Units, we agreed that for each share of Series G Preferred Stock purchased by an investor, the exercise price of one warrant to purchase one share of Common Stock, previously issued to the investor in prior offerings by the Company to purchase Common Stock of the Company held of record by such investor, shall be reduced to $0.60 per share and will remain at such reduced exercise price until the expiration date of the warrants.

In connection with the sale of Series G Units, we treated the reduction in exercise price as a warrant amendment and calculated the fair value of 1,495,022 warrants with the reduced exercise price of $0.60, as described above, using the Black-Scholes model with the below assumptions. The Company has determined that the fair value of the amended warrants increased as compared with the fair value of the original warrants immediately prior to amendment.

 
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In connection with the warrant amendments, we calculated the fair value of the warrants, as described above, using a Black-Scholes model with the below assumptions.

Assumptions
 
Series A
   
Series A
   
Series B
   
Series C
   
Aug/Sep 2011
   
Feb 2012
 
         
(Affiliates)
               
Notes
   
PIPE
 
Contractual life, in years
    4.1       3.1       3.1       5.1       2.1       4.6  
Expected volatility
    132.0 %     114.1 %     114.1 %     121.9 %     126.6 %     126.6 %
Risk-free interest rate
    0.4 %     0.4 %     0.4 %     0.4 %     0.4 %     0.4 %
Exercise price
  $ 0.60     $ 0.60     $ 0.60     $ 0.60     $ 0.60     $ 0.60  
Fair value per warrant
  $ 0.03     $ 0.03     $ 0.03     $ 0.03     $ 0.03     $ 0.03  

We recorded an increased incremental value of $5,347 for the warrant amendment and treated the excess of fair value of the warrants as a deemed dividend for the year ended December 31, 2012.
 
Series H Convertible Preferred Stock

On December 28, 2012 the Company amended the Articles of Incorporation to authorize 10,000 shares of Series H Convertible Preferred Stock.  On January 4, 2013, the Company reported that it had entered into a securities purchase and exchange agreement with an investor, pursuant to which the Company agreed to exchange 1,000,000 shares of the Company’s common stock, par value $0.01 per share of common stock held by the investor  for an aggregate of 10,000 shares of a newly created series of preferred stock, designated Series H Convertible Preferred Stock, par value $0.01 per share (the “Series H Preferred Stock”)  in a non-cash transaction. The investor originally purchased the common stock from the Company for $0.8025 per share. The exchange ratio was 100 shares of common stock per share of Series H Preferred Stock at a stated conversion price of $0.8025 per share.
 
Series J Convertible Preferred Stock

On February 6, March 28 and May 20, 2013, the Company entered into a Securities Purchase with various individuals pursuant to which the Company sold an aggregate of 5,087.5 units for a purchase price of $400.00 per unit (the “Purchase Price”), or an aggregate Purchase Price of $2,034,700.  Each unit purchased in the initial tranche consists of (i) one share of a newly created series of preferred stock, designated Series J Convertible Preferred Stock, par value $0.01 per share (the “Series J Convertible Preferred Stock”), convertible into 1,000 shares of the Company’s common stock, par value $0.01 per share and (ii) a warrant to purchase 1,000 shares of common stock at an exercise price equal to $0.40 per share. The warrants expire three years from the issuance date. Of the $2,034,700 invested in the Private Placement, $921,000 was received in cash and $1,113,700 was from the conversion of outstanding indebtedness, interest and accrued board of directors’ fees.  The Company incurred $24,405 of legal fees in conjunction with this private placement. The purchasers in the initial tranche of the private placement consisted of certain existing and new investors in the Company as well as all of the members of the Company’s Board of Directors.

From the date of issuance of any shares of Series J Convertible Preferred Stock and until the earlier of the first anniversary of such date, the voluntary conversion of any shares of Series J Convertible Preferred Stock, or the date of any mandatory conversion of the Series J Convertible Preferred Stock, dividends will accrue on each share of Series J Convertible Preferred Stock at an annual rate of (i) four percent (4%) of the Purchase Price on those shares of Series J Convertible Preferred Stock purchased from the Company pursuant to the Securities Purchase Agreement by an individual purchaser who purchased from the Company shares of Series J Convertible Preferred Stock with an aggregate Purchase Price of less than $250,000, and (ii) six percent (6%) of the Purchase Price on those shares of Series J Convertible Preferred Stock purchased from the Company pursuant to the Securities Purchase Agreement by an individual purchaser who purchased shares of Series J Convertible Preferred Stock with an aggregate purchase price of at least $250,000.  Dividends accruing on the Series J Convertible Preferred Stock shall accrue from day to day until the earlier of the first anniversary of the date of issuance of such shares of Series J Convertible Stock, the voluntary conversion of any shares of Series J Convertible Preferred Stock, or the date of any mandatory conversion of the Series J Convertible Preferred Stock, and shall be paid, as applicable, within fifteen (15) days of the first anniversary of the original issue date of the Series J Convertible Preferred Stock, within five (5) days of the voluntary conversion of shares of the Series J Convertible Preferred Stock, or within five (5) days of the mandatory conversion of shares of the Series J Convertible Preferred Stock. The Company may pay accrued dividends on the Series J Convertible Preferred Stock in cash or, in the sole discretion of the Board of Directors of the Company, in shares of its common stock in accordance with a specified formula.

Each share of Series J Convertible Preferred Stock is convertible into 1,000 shares of common stock at the option of the holder on or after the six-month anniversary of the issuance of such share, subject to adjustment for stock splits, stock dividends, recapitalizations and similar transactions (the “Conversion Ratio”). Unless waived under certain circumstances by the holder of Series J Convertible Preferred Stock, such holder’s shares of Series J Convertible Preferred Stock may not be converted if upon such conversion the holder’s beneficial ownership would exceed certain thresholds.

 
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At the election of the Company and upon required advance notice, each share of Series J Convertible Preferred Stock will automatically be converted into shares of common stock at the Conversion Ratio then in effect:  (i) on or after the six-month anniversary of the original issuance date of the Series J Convertible Preferred Stock, the common stock trades on the OTC QB Market (or other primary trading market or exchange on which the common stock is then traded) at a price per share equal to at least $0.80 for 7 out of 10 consecutive trading days with average daily trading volume of at least 50,000 shares, (ii) on the first anniversary of the original issuance date of the Series J Convertible Preferred Stock or (iii) within three days of the completion of a firm-commitment underwritten registered public offering by the Company at a per share price equal to at least $0.80, with aggregate gross proceeds to the Company of not less than $2.5 million.  Unless waived under certain circumstances by the holder of the Series J Convertible Preferred Stock, such holder’s Series J Convertible Preferred Stock may not be converted if upon such conversion the holder’s beneficial ownership would exceed certain thresholds.

The proceeds from the sale of each Series J Unit were allocated between the Series J Convertible Preferred Stock and the Series J Warrants based on the relative fair value method.  The estimated fair value of the Series J Warrants was determined using a Black Scholes formula, resulting in an allocation of the gross proceeds of $885,309 to the total warrants issued.  The allocation of the gross proceeds to the Series J Convertible Preferred Stock was $1,124,986, net of $24,405 in legal costs.  In accordance with the provisions of ASC 470-20, an additional adjustment between Additional Paid in Capital and Accumulated Deficit of $651,182 was recorded to reflect an implicit non-cash dividend related to the allocation of proceeds between the stock and warrants issued. The $651,182 represents the value of the adjustment to additional paid in capital related to the beneficial conversion feature of the Series J Convertible Preferred Stock.  The value adjustment was calculated by subtracting the fair market value of the underlying common stock on February 6, March 28 and May 20, 2013 issuable upon conversion of the Series J Convertible Preferred Stock from the fair market value of the Series J Convertible Preferred Stock as determined when the Company performed a fair market value allocation of the proceeds to the Series J Convertible Preferred Stock and warrants.

In connection with the Series J warrants, we calculated the fair value of the warrants received as described above using the Black- Scholes formula with the below assumptions:

Assumptions
 
Series J warrants February 6,
2013
   
Series J warrants
March 28,
2013
   
Series J warrants
May 20,
2013
 
Contractual life (in months)
    36       36       36  
Expected volatility
    141.8       144.3       147.0  
Risk-free interest rate
    0.39 %     0.36 %     0.36 %
Exercise price
  $ 0.40     $ 0.40     $ 0.40  
Fair value per warrant
  $ 0.36     $ 0.26     $ 0.30  
 
The holders of Series J Convertible Preferred Stock are not entitled to vote on any matters presented to the stockholders of the Company for their action or consideration at any meeting of stockholders of the Company (or by written consent of stockholders in lieu of meeting), except as required by law.

Series J Warrants
 
The Warrants issued in the Private Placement have an exercise price equal to $0.40 per share, with a term expiring three years from the issuance date.  The Warrants also permit the holder to conduct a “cashless exercise” at any time the holder of the Warrant is an affiliate of the Company.  The exercise price and/or number of shares issuable upon exercise of the Warrants will be subject to adjustment for stock dividends, stock splits or similar capital reorganizations, as set forth in the Warrant agreement.

Subject to the terms and conditions of the Warrants, at any time commencing six months from the closing date of the sale of Units under the Securities Purchase Agreement the Company has the right to call the Warrants for cancellation if the volume weighted average price of its common stock on the OTC QB Market (or other primary trading market or exchange on which the common stock is then traded) equals or exceeds three times the per share exercise price of the Warrants for either (i) 10 consecutive trading days or (ii) 15 out of 25 consecutive trading days.

Registration Rights Agreement

In connection with the Private Placement, the Company has agreed that, if, at any time after February 1, 2014, the Company files a Registration Statement relating to an offering of equity securities of the Company (the “Registration Statement”), subject to certain exceptions, including a Registration Statement relating solely to an offering or sale of securities having an aggregate public offering price of less than $5,000,000, the Company shall include in the Registration Statement the resale of the shares of common stock underlying the Warrants.  Shares of common stock issued upon conversion of Series J Convertible Preferred Stock or in payment of the dividend on the Series J Convertible Preferred Stock will not be registered and will not be subject to registration rights.  This right is subject to customary conditions and procedures.
 
 
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Series K Convertible Preferred Stock

On December 12, 2013, the Company entered into a Securities Purchase with various individuals pursuant to which the Company sold an aggregate of 4,000 units for a purchase price of $250.00 per unit (the “Purchase Price”), for an aggregate Purchase Price of $1,000,000.  Each unit purchased in the initial tranche consists of (i) one share of a newly created series of preferred stock, designated Series K Convertible Preferred Stock, par value $0.01 per share (the “Series K Convertible Preferred Stock”), convertible into 1,000 shares of the Company’s common stock, par value $0.01 per share and (ii) a warrant to purchase 500 shares of common stock at an exercise price equal to $0.3125 per share. The warrants expire three years from the issuance date. Of the $1,000,000 invested in the Private Placement, $527,044 was received in cash and $427,956 was from the conversion of outstanding indebtedness and interest. The Company incurred $43,334 of fees in conjunction with this private placement. The purchasers in the initial tranche of the private placement consisted of certain existing and new investors in the Company as well as all of the members of the Company’s Board of Directors.

From the date of issuance of any shares of Series K Convertible Preferred Stock and until the earlier of the first anniversary of such date, the voluntary conversion of any shares of Series K Convertible Preferred Stock, or the date of any mandatory conversion of the Series K Convertible Preferred Stock, dividends will accrue on each share of Series K Convertible Preferred Stock at an annual rate of (i) four percent (4%) of the Purchase Price on those shares of Series K Convertible Preferred Stock purchased from the Company pursuant to the Securities Purchase Agreement by an individual purchaser who purchased from the Company shares of Series K Convertible Preferred Stock with an aggregate Purchase Price of less than $100,000, and (ii) six percent (6%) of the Purchase Price on those shares of Series K Convertible Preferred Stock purchased from the Company pursuant to the Securities Purchase Agreement by an individual purchaser who purchased shares of Series K Convertible Preferred Stock with an aggregate purchase price of at least $100,000.  Dividends accruing on the Series K Convertible Preferred Stock shall accrue from day to day until the earlier of the first anniversary of the date of issuance of such shares of Series K Convertible Stock, the voluntary conversion of any shares of Series K Convertible Preferred Stock, or the date of any mandatory conversion of the Series K Convertible Preferred Stock, and shall be paid, as applicable, within fifteen (15) days of the first anniversary of the original issue date of the Series K Convertible Preferred Stock, within five (5) days of the voluntary conversion of shares of the Series K Convertible Preferred Stock, or within five (5) days of the mandatory conversion of shares of the Series K Convertible Preferred Stock. The Company may pay accrued dividends on the Series K Convertible Preferred Stock in cash or, in the sole discretion of the Board of Directors of the Company, in shares of its common stock in accordance with a specified formula.

Each share of Series K Convertible Preferred Stock is convertible into 1,000 shares of common stock at the option of the holder on or after the six-month anniversary of the issuance of such share, subject to adjustment for stock splits, stock dividends, recapitalizations and similar transactions (the “Conversion Ratio”). Unless waived under certain circumstances by the holder of Series K Convertible Preferred Stock, such holder’s shares of Series K Convertible Preferred Stock may not be converted if upon such conversion the holder’s beneficial ownership would exceed certain thresholds.

At the election of the Company and upon required advance notice, each share of Series K Convertible Preferred Stock will automatically be converted into shares of common stock at the Conversion Ratio then in effect:  (i) on or after the six-month anniversary of the original issuance date of the Series K Convertible Preferred Stock, the common stock trades on the OTC QB Market (or other primary trading market or exchange on which the common stock is then traded) at a price per share equal to at least $0.80 for 7 out of 10 consecutive trading days with average daily trading volume of at least 50,000 shares, (ii) on the first anniversary of the original issuance date of the Series K Convertible Preferred Stock or (iii) within three days of the completion of a firm-commitment underwritten registered public offering by the Company at a per share price equal to at least $0.80, with aggregate gross proceeds to the Company of not less than $2.5 million.  Unless waived under certain circumstances by the holder of the Series K Convertible Preferred Stock, such holder’s Series K Convertible Preferred Stock may not be converted if upon such conversion the holder’s beneficial ownership would exceed certain thresholds.

The proceeds from the sale of each Series K Unit were allocated between the Series K Convertible Preferred Stock and the Series K Warrants based on the relative fair value method.  The estimated fair value of the Series K Warrants was determined using a Black-Scholes formula, resulting in an allocation of the gross proceeds of $271,422 to the total warrants issued.  The allocation of the gross proceeds to the Series K Convertible Preferred Stock was $685,245, net of $43,334 in fees.  In accordance with the provisions of ASC 470-20, an additional adjustment between Additional Paid in Capital and Accumulated Deficit of $351,421 was recorded to reflect an implicit non-cash dividend related to the allocation of proceeds between the stock and warrants issued. The $351,421 represents the value of the adjustment to additional paid in capital related to the beneficial conversion feature of the Series K Convertible Preferred Stock.  The value adjustment was calculated by subtracting the fair market value of the underlying common stock on December 12, 2013 issuable upon conversion of the Series K Convertible Preferred Stock from the fair market value of the Series K Convertible Preferred Stock as determined when the Company performed a fair market value allocation of the proceeds to the Series K Convertible Preferred Stock and warrants.

 
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In connection with the Series K warrants, we calculated the fair value of the warrants received as described above using the Black- Scholes formula with the below assumptions:
 
Assumptions
 
Series K warrants
December 12,
2013
 
Contractual life (in months)
    36  
Expected volatility
    136.1  
Risk-free interest rate
    0.39 %
Exercise price
  $ 0.3125  
Fair value per warrant
  $ 0.2012  
 
The holders of Series K Convertible Preferred Stock are not entitled to vote on any matters presented to the stockholders of the Company for their action or consideration at any meeting of stockholders of the Company (or by written consent of stockholders in lieu of meeting), except as required by law.

Series K Warrants
 
The Warrants issued in the Private Placement have an exercise price equal to $0.3125 per share, with a term expiring three years from the issuance date.  The Warrants also permit the holder to conduct a “cashless exercise” at any time the holder of the Warrant is an affiliate of the Company.  The exercise price and/or number of shares issuable upon exercise of the Warrants will be subject to adjustment for stock dividends, stock splits or similar capital reorganizations, as set forth in the Warrant agreement.

Subject to the terms and conditions of the Warrants, at any time commencing six months from the closing date of the sale of Units under the Securities Purchase Agreement the Company has the right to call the Warrants for cancellation if the volume weighted average price of its common stock on the OTC QB Market (or other primary trading market or exchange on which the common stock is then traded) equals or exceeds three times the per share exercise price of the Warrants for either (i) 10 consecutive trading days or (ii) 15 out of 25 consecutive trading days.

Registration Rights Agreement

In connection with the Private Placement, the Company has agreed that, if, at any time after February 1, 2014, the Company files a Registration Statement relating to an offering of equity securities of the Company (the “Registration Statement”), subject to certain exceptions, including a Registration Statement relating solely to an offering or sale of securities having an aggregate public offering price of less than $5,000,000, the Company shall include in the Registration Statement the resale of the shares of common stock underlying the Warrants.  Shares of common stock issued upon conversion of Series K Convertible Preferred Stock or in payment of the dividend on the Series K Convertible Preferred Stock will not be registered and will not be subject to registration rights.  This right is subject to customary conditions and procedures.
 
 
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 Common Stock

Shareholders Purchase Rights Plan

On March 3, 2003, our Board of Directors adopted a shareholder purchase rights plan (“the Rights Plan”) and declared a distribution of one Right for each outstanding share of our  Common Stock to shareholders of record at the close of business on March 21, 2003 (the “Rights”). Initially, the Rights will trade automatically with the Common Stock and separate Right Certificates will not be issued. The Rights Plan is designed to deter coercive or unfair takeover tactics and to ensure that all of our shareholders receive fair and equal treatment in the event of an unsolicited attempt to acquire the Company. The Rights Plan was not adopted in response to any effort to acquire the Company and the Board is not aware of any such effort. The Rights will expire on February 27, 2013 unless earlier redeemed or exchanged. Each Right entitles the registered holder, subject to the terms of a Rights Agreement, to purchase from the Company one one-thousandth of a share of the Company’s Series A Junior Participating Preferred Stock at a purchase price of $45.00 per one one-thousandth of a share, subject to adjustment. In general, the Rights will not be exercisable until a subsequent distribution date which will only occur if a person or group acquires beneficial ownership of 15% or more of our Common Stock or announces a tender or exchange offer that would result in such person or group owning 15% or more of the Common Stock. With respect to any person or group who currently beneficially owns 15% or more of our Common Stock, the Rights will not become exercisable unless and until such person or group acquires beneficial ownership of additional shares of Common Stock.

Subject to certain limited exceptions, if a person or group acquires beneficial ownership of 15% or more of our outstanding  Common Stock or if a current 15% beneficial owner acquires additional shares of  Common Stock, each holder of a Right (other than the 15% holder whose Rights become void once such holder reaches the 15% threshold) will thereafter have a right to purchase, upon payment of the purchase price of the Right, that number of shares of our  Common Stock which at the time of such transaction will have a market value equal to two times the purchase price of the Right In the event that, at any time after a person or group acquires 15% or more of our  Common Stock, we are acquired in a merger or other business combination transaction or 50% or more of its consolidated assets or earning power are sold, each holder of a Right will thereafter have the right to purchase, upon payment of the purchase price of the Right, that number of shares of  Common Stock of the acquiring company which at the time of such transaction will have a market value of two times the purchase price of the Right.

Our Board of Directors may exchange the Rights (other than Rights owned by such person or group which have become void), in whole or in part, at an exchange ratio of one share of Common Stock per Right (subject to adjustment). At any time prior to the time any person or group acquires 15% or more of our Common Stock, the Board of Directors may redeem the Rights in whole, but not in part, at a price of $0.001 per Right.

Stock Options and Warrants

Our stockholders approved our amended 2005 Equity Incentive Plan (the “Plan”) pursuant to which an aggregate of 1,800,000 shares of our  Common Stock were reserved for issuance upon exercise of stock options or other equity awards made under the Plan. Under the Plan, we may award stock options, shares of  Common Stock, and other equity interests in the Company to employees, officers, directors, consultants, and advisors, and to any other persons the Board of Directors deems appropriate. As of December 31, 2013, options to acquire 1,738,708 shares were outstanding under the Plan with 61,292 shares available for future grant under the Plan.

As of December 31, 2013, options to acquire 33,000 shares are outstanding under the 1999 Non-qualified Stock Option Plan. No additional options may be granted under the 1999 Non-qualified Stock Option Plan.

All of the outstanding options had an exercise price that was above the Company’s Common Stock share price on December 31, 2013.

On December 12, 2013 at the Company’s special meeting the shareholders approved the 2013 Equity Incentive Plan (the “2013 Plan”) pursuant to which 3,000,000 shares of our Common Stock were reserved for issuance upon exercise of stock options or other equity awards under the 2013 Plan. Under the Plan, we may award stock options, shares of  Common Stock, and other equity interests in the Company to employees, officers, directors, consultants, and advisors, and to any other persons the Board of Directors deems appropriate. As of December 31, 2013 no options have been granted under the 2013 Plan.

 
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The following tables summarize information concerning options and warrants outstanding and exercisable:

   
Stock Options
   
Warrants
             
   
Weighted
   
Weighted
             
   
Average price
   
Average price
   
Total
 
   
Shares
   
per share
   
Shares
   
per share
   
Shares
   
Exercisable
 
Balance outstanding, January 1, 2012
    1,508,500     $ 2.33       4,775,501     $ 1.35       6,284,001       6,112,335  
   Granted
    1,896,250       0.81       2,909,068       0.62       4,805,318          
   Exercised
    -       -       -       -       -          
   Expired
    (130,000 )     2.28       (116,490 )     2.80       (246,490 )        
   Forfeited
    (1,669,000 )     2.09       (880,980 )     2.13       (2,549,980 )        
Balance outstanding, December 31, 2012
    1,605,750     $ 0.80       6,687,099     $ 0.81       8,292,849       7,989,331  
   Granted
    363,500       0.41       8,346,228       0.37       8,709,728          
   Exercised
    -       -       -       -       -          
   Expired
    (10,000 )     1.00       (21,000 )     2.38       (31,000 )        
   Forfeited
    (187,542 )     .85       -       -       (187,542 )        
Balance outstanding, December 31, 2013
    1,771,708     $ 0.71       15,012,327     $ 0.57       16,784,035       16,611,528  
 
The weighted average grant date fair value of options issued was $0.35 for the year ending December 31, 2013.
 
     
Options Outstanding
   
Options Exercisable
 
           
Weighted Average
         
Weighted Average
 
Range of Exercise Prices
   
Number of Options
   
Remaining Contractual Life (Years)
   
Exercise Price
   
Number of Options
   
Remaining Contractual Life (Years)
   
Exercise Price
 
$0.00 - $0.49       321,000       9.4     $ 0.40       255,208       9.4     $ 0.40  
0.50 - 0.59       251,250       8.6       0.50       251,250       8.6       0.50  
0.60 - 0.99       475,250       6.0       0.60       416,658       5.7       0.60  
1.00 - 1.50       724,208       3.2       1.00       676,085       2.9       1.00  
$0.50 - $1.00       1,771,708       5.9     $ 0.71       1,599,201       5.6     $ 0.72  

There was $65,953 of total unrecognized compensation cost, net of estimated forfeitures, related to non-vested stock options granted as of December 31, 2013. This cost is expected to be recognized over a period of 2.1 years, and will be adjusted for any future changes in estimated forfeitures.

Sale of Common Stock

On February 7, 2012, we completed a private placement with 7 accredited investors, pursuant to which we sold an aggregate of 971,867 shares of  Common Stock, $0.01 par value (“Shares”), resulting in gross proceeds to us of $800,000 (the “Private Placement”). The price per unit was $0.8025 for units consisting of 789,350 shares of Common Stock and warrants to purchase 394,677 shares of Common Stock, and was $0.9125 for units consisting of the remaining 182,517 shares of Common Stock and warrants to purchase 91,260 shares of Common Stock. Of the $800,000 invested in the private placement, $412,453 was received in cash and $387,547 was from the conversion of outstanding principal and interest on convertible promissory notes issued by us in 2011.

Each unit consists of one share of Common Stock and a warrant to purchase one-half share of Common Stock. The warrants are exercisable for a period of five years, commencing on August 7, 2012, at an exercise price of $0.74 per share for the purchasers of the 789,350 shares, and $0.85 per share for the purchasers of the 182,517 shares. The warrants permit the holder to conduct a “cashless exercise” at any time the holder is an affiliate. The exercise price and/or number of shares of Common Stock issuable upon exercise of the warrants will be subject to adjustment for certain stock dividends, stock splits or similar capital reorganizations.

In connection with the Private Placement, we paid our investment banker a fee of $35,000 for providing advisory services. We accounted for this fee as a reduction in the gross proceeds received from the Private Placement.

 
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 Common Stock Issuances

On February 1, 2013, we issued 100,000 shares of restricted Common Stock to an investor relations firm in payment of services to be rendered over eight months. We recorded $40,000 for this issuance of which will be amortized over the eight months. On March 18, 2013, we issued 200,000 shares of restricted Common Stock to an investor relations firm for payment of services to be rendered over eight months. We recorded $80,000 for this issuance as expense. On August 1, 2013, we issued 200,000 shares of restricted Common Stock to an investor relations firm for payment of services to be rendered over six months. We recorded $80,000 for this issuance and recognized $66,087 as expense in 2013 with $13,913 to be expensed in 2014. On September 1, 2013, we issued 200,000 shares of restricted Common Stock to an investor relations firm for payment of services to be rendered over three months. We recorded $80,000 for this issuance which was recorded as expense in 2013. On September 10, 2013, we issued 100,000 shares of restricted Common Stock to an investor relations firm for payment of services to be rendered over four months. We recorded $40,000 for this issuance and recognized expense of $36,721 in 2013 with $3,279 to be expensed in 2014.  On December 23, 2013 we issued 75,000 shares of restricted Common Stock to a lender in connection with the sale of debentures.  We recognized $17,250 as deferred financing costs that will be recognized over the life of the note. We valued the above stock issuances using the greater of the estimated fair value of the services received or the Company’s stock price on date of issuance.
 
Warrant Derivative Liability

The Series D Warrants issued in connection with the registered direct offering of Series D Convertible Preferred are measured at fair value and liability-classified because the Series D Warrants contain “down-round protection” and therefore, do not meet the scope exception for treatment as a derivative under ASC 815, Derivatives and Hedging, (“ASC 815”). Since “down-round protection” is not an input into the calculation of the fair value of the warrants, the warrants cannot be considered indexed to the Company’s own stock which is a requirement for the scope exception as outlined under ASC 815. The estimated fair value of the warrants was determined using the binomial model, resulting in an allocation of the gross proceeds $283,725 to the warrants issued in the Series D registered direct offering. The fair value will be affected by changes in inputs to that model including our stock price, expected stock price volatility, the contractual term, and the risk-free interest rate. We will continue to classify the fair value of the warrants as a liability until the warrants are exercised, expire or are amended in a way that would no longer require these warrants to be classified as a liability, whichever comes first. The down-round protection for the Series D Warrants survives for the life of the Series D Warrants which ends in May 2017.
 
The assumptions for the binomial pricing model are represented in the table below for the warrants issued in the Series D private placement reflected on a per share  Common Stock equivalent basis.

Assumptions
 
November 10,
2011
   
Warrants revalued at
December 31,
2012
   
Warrants revalued at
December 31,
2013
 
Expected life (in months)
    60.0       43.0       34.0  
Expected volatility
    104.5 %     146.4 %     154.8 %
Risk-free interest rate
    0.875 %     0.437 %     0.78 %
Exercise price
  $ 0.81     $ 0.40     $ 0.25  
Fair value per warrant
  $ 0.54     $ 0.15     $ 0.21  

As of December 31, 2013, the value of the Series D Warrants had increased to $344,570.

Conversion Option Liability

The Company signed five convertible notes and has determined that conversion options are embedded in the notes and it is required to bifurcate the conversion option from the host contract under ASC 815 and account for the derivatives at fair value. The estimated fair value of the conversion options was determined using the binomial model. The fair value of the conversion options will be classified as a liability until the debt is converted by the note holders or paid back by the Company.  The fair value will be affected by changes in inputs to that model including our stock price, expected stock price volatility, the contractual term, and the risk-free interest rate.  We will continue to classify the fair value of the conversion options as a liability until the conversion options are exercised, expire or are amended in a way that would no longer require these conversion options to be classified as a liability, whichever comes first. The Company has adopted a sequencing policy that reclassifies contracts (from equity to liabilities) with the most recent inception date first.  Thus any available shares are allocated first to contracts with the most recent inception dates.

The assumptions for the binomial pricing model are disclosed in Note 2. As of December 31, 2013, the value of the Conversion Option liability was $356,197.
 
 
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(8)  
Subsequent Events

We performed a review of events subsequent to the balance sheet date through the date the financial statements were issued and determined, except as disclosed herein, that there were no other such events requiring recognition or disclosure in the financial statements.
 
  
On January 29 and February 28, 2014, the Company entered into a Securities Purchase Agreement with various individuals pursuant to which the Company sold an aggregate of 4,875 units for a purchase price of $250.00 per unit and 1,854 units for a purchase price of $340.00 per unit, respectively, or an aggregate Purchase Price of $1,849,110.  This represents the second and third tranches of a $1.5 million private placement which was subsequently increased to $3.5 million and extended to April 4, 2014.  Each unit purchased in the second and third tranche (“Unit”) consists of (i) one share of a newly created series of preferred stock, designated Series K Convertible Preferred Stock, par value $0.01 per share convertible into 1,000 shares of the Company’s Common Stock, par value $0.01 per share and (ii) a warrant to purchase 500 shares of Common Stock at an exercise price equal to one hundred and twenty-five percent of the common stock equivalent price per share, with a term expiring three years from the respective closing date.
 
  
In February 2014, the Company chose to pay off the April 11, 2013 and June 26, 2013 loan balances, see Note 7.  The holder of the note chose to convert $37,500 of the outstanding balance to 150,000 shares of Company common stock, resulting in a cash payment of $203,100.
 
  
On February 6, 2014 the Company paid off the $75,000 balance of the promissory note, see Note 7, along with accrued interest on the note.
 
  
In March 2014, a Series D warrant holder exercised warrants to purchase 450,000 shares of common stock resulting in net proceeds to the Company of $112,500.
 
 
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ITEM 9.   CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.

None
 
ITEM 9A.    CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Securities Exchange Act of 1934 filings are recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our President and Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer (Principal Financial Officer), as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, as ours are designed to do, and management was necessarily required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

As of December 31, 2013, we carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934. Based upon that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were not effective as of December 31, 2013 due to limited resources for adequate personnel to prepare and file reports under the Securities Exchange Act of 1934 within the required periods, and material weaknesses in our internal control over financial reporting relating to our accounting for complex equity transactions as described below under the heading “Report of Management on Internal Control over Financial Reporting”. Management plans to remediate this weakness by taking the actions described below.

Report of Management on Internal Control over Financial Reporting

We are responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act, as a process designed by, or under the supervision of our principal executive and principal financial officers and effected by our board of directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:

  
pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and disposition of our assets;
  
provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorization of our management and directors; and
  
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.

Our internal control system is designed to provide reasonable assurance to our management and board of directors regarding the preparation and fair presentation of published financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

We have assessed the effectiveness of our internal control over financial reporting as of December 31, 2013. In making this assessment, we used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework.

Based on this assessment, management believes that, as of December 31, 2013, the Company did not maintain effective internal control over financial reporting because of the effect of a material weakness in our internal control over financial reporting discussed below.
 
       Public Company Accounting Oversight Board Auditing Standard No. 2 defines a material weakness as a significant deficiency, or combination of significant deficiencies, that results in there being a more than remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis. Based upon this definition, our management concluded that, as of December 31, 2013, a material weakness existed in our internal control over financial reporting related to accounting for complex equity transactions.
 
 
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       Specifically, we identified material weaknesses in our internal control over financial reporting related to the following matters:

  
We identified a lack of sufficient segregation of duties. Specifically, this material weakness is such that the design over these areas relies primarily on detective controls and could be strengthened by adding preventative controls to properly safeguard company assets.

  
Management has identified a lack of sufficient personnel in the accounting function due to our limited resources with appropriate skills, training and experience to perform the review processes to ensure the complete and proper application of generally accepted accounting principles, particularly as it relates to valuation of warrants and other complex debt /equity transactions. Specifically, this material weakness led to segregation of duties issues and resulted in audit adjustments to the annual consolidated financial statements and revisions to related disclosures, valuation of warrants and other equity transactions.

Our plan to remediate those material weaknesses is as follows:

  
Improve the effectiveness of the accounting group by continuing to augment our existing resources with additional consultants or employees to improve segregation procedures and to assist in the analysis and recording of complex accounting transactions. We plan to mitigate the segregation of duties issues by hiring an independent consultant once we generate significantly more revenue or raise significant additional working capital.

  
Improve segregation procedures by strengthening cross approval of various functions including quarterly internal audit procedures where appropriate.

Changes in Internal Control Over Financial Reporting

There have been no changes in our internal control over financial reporting that occurred during the fourth quarter of 2013, other than as described above, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
 
ITEM 9B.    OTHER INFORMATION.

None.
 
 
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PART III

ITEM 10.    DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
 
Directors
 
The following table sets forth information about the individuals who serve as our directors as of December 31, 2013.
 
Name
 
Age
 
Position
 
Board Committees
 
Term of office
 
Richard T. Schumacher
  63  
President, Chief Executive Officer, Treasurer, Clerk and Director
        2014  
Jeffrey N. Peterson
  58  
Chairman of the Board
 
Audit, Compensation, Nominating
    2015  
Dr. Mickey Urdea
  62  
Director
        2014  
Vito J. Mangiardi
  65  
Director
 
Audit, Compensation, Nominating
    2016  
Kevin A. Pollack
  43  
Director
 
Audit, Compensation, Nominating
    2016  
 
The following noteworthy experience, qualifications, attributes and skills for each Board member, together with the biographical information for each nominee described below, led to our conclusion that the person should serve as a director of PBI in light of our business and structure:
 
  
Mr. Richard T. Schumacher, the Company’s founder, provides valuable operational, sales and marketing, financial, and management expertise and experience and has significant knowledge of the Company’s technology and products. Prior to founding the company, Mr. Schumacher spent over 16 years working in the clinical research setting. In the more than 30 years since the Company’s formation, Mr. Schumacher has served the Company in various roles, including President, Chief Executive Officer and Chairman.
 
  
Mr. Jeffrey N. Peterson, the Chairman of our Board, is the CEO of Target Discovery, Inc., a personalized medicine diagnostics company, and has broad executive, general management, multi-functional, multi-business, and international experience.
 
  
Mr. Vito J. Mangiardi has broad executive, general management, multi-functional, multi-business, and international experience, specifically in the life sciences field.
 
  
Mr. Kevin A. Pollack provides a wealth of knowledge and experience in financial and administrative matters. Mr. Pollack recently served as managing director of Paragon Capital LP, a private investment firm, and serves as Chief Financial Officer of Lightlake Therapeutics Inc.
 
  
Dr. Michael S. “Mickey” Urdea offers significant scientific and technical experience from leading research and development programs in both small and large life sciences companies, and entrepreneurial experience from founding and leading successful personalized medicine and consulting companies in the biotechnology field.
 
        Mr. Richard T. Schumacher, the founder of the Company, has served as a director of the Company since 1978. He has served as the Company’s CEO since April 16, 2004 and president since September 14, 2004. He previously served as CEO and chairman of the Board of the Company from 1992 to February 2003. From July 9, 2003 until April 14, 2004 he served as a consultant to the Company pursuant to a consulting agreement. He served as president of the Company from 1986 to August 1999. Mr. Schumacher served as the Director of Infectious Disease Services for Clinical Sciences Laboratory, a New England-based medical reference laboratory, from 1986 to 1988. From 1972 to 1985, Mr. Schumacher was employed by the Center for Blood Research, a nonprofit medical research institute associated with Harvard Medical School. Mr. Schumacher received a B.S. in Zoology from the University of New Hampshire.

 
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Mr. Jeffrey N. Peterson has served as a director since July 2011 and as our board chairman since July 2012. Since 1999, he has served as the chief executive officer of Target Discovery, Inc. (“TDI”), a personalized medicine diagnostics (PMDx) company. Mr. Peterson also serves as Chairman of TDI’s majority-owned subsidiary, Veritomyx, Inc., which is completing development and commercialization of a tool in accurate peptide, protein and isoform identification and characterization. Prior to joining TDI, Mr. Peterson served as CEO of Sharpe, Peterson, Ocheltree & Associates, an international business development consulting firm assisting Fortune 500 and many smaller firms in business expansion and strategy, for three years prior to incorporating TDI. Prior to that, he spent 9 years in key management roles in Abbott Laboratories’ Diagnostics and International (Pharmaceuticals, Hospital Products, Nutritionals, and Consumer) businesses, last serving as CEO and General Manager of Abbott South Africa. Mr. Peterson’s experience prior to Abbott Laboratories included 11 years with General Electric’s Engineered Materials and Plastics businesses, spanning roles in strategic planning, business development, technology licensing, marketing and sales, operations, quality control and R&D. Mr. Peterson holds BSChE and MSChE (Chemical Engineering) degrees from MIT. He serves as Chair Emeritus of the BayBio Institute, a non-profit organization serving the life science community, and on the board of BayBio, a trade association for the life sciences industry in Northern California. He is a member of the Coalition for 21st Century Medicine, and of BIO’s Personalized Medicine & Diagnostics Group. Mr. Peterson has served on the board of directors SanGlobal Ed Corp. (d/b/a MyVerse), a teen and collegiate personal and professional development web and mobile resource site. Mr. Peterson serves on the Advisory Board for the University of Texas, MD Anderson Cancer Center, Center for Professional Development and Entrepreneurship.

Mr. Vito J. Mangiardi has served as a director since July 2012. Mr. Mangiardi is a senior executive with experience as a President, CEO and COO in the Life Sciences and Bio Energy product and service sectors. He is a corporate strategist in General Management, Operations, Sales/Marketing, and Science.  Mr. Mangiardi has held positions as a Research Chemist for Bio-Rad Laboratories, Inc.; Sales & Marketing Director for Baxter Travenol, Inc.; Executive VP and COO for Quintiles Transnational Corp.; President and CEO of Diagnostics Laboratories, Inc., Clingenix, Inc., and Bilcare, Inc.; and President of AAI Pharma, Inc.  More recently he was the COO/Deputy Director of Operations and Production at the University of California Lawrence Berkeley National Laboratory Joint Genome Institute. Mangiardi earned a BS in Biology/Chemistry from Eastern Illinois University and two MBA degrees from Golden Gate University - in General Management and in Marketing. Mr. Mangiardi is listed as an inventor in eight patents and is a member of numerous professional organizations.

      Mr. Kevin A. Pollack has served as a director since July 2012.  Mr. Pollack serves as President of Short Hills Capital LLC, where he has provided a range of advisory services to investors, asset management firms, institutions, and companies. Previously, he worked in asset management at Paragon Capital, and as an investment banker at Banc of America Securities LLC, focusing on corporate finance and mergers and acquisitions. He started his career at Sidley Austin LLP (formerly Brown & Wood LLP) as a securities attorney focusing on corporate finance, and on mergers and acquisitions. Mr. Pollack currently sits on the Board of Directors of Lightlake Therapeutics Inc., a developing biopharmaceutical company focused on building a platform of biopharmaceutical solutions to common addictions and related disorders, where he also serves as CFO, and on the Board of Directors of MagneGas Corporation, the developer of a technology that converts liquid waste into a hydrogen-based metal working fuel and natural gas alternative. Mr. Pollack graduated magna cum laude from The Wharton School of the University of Pennsylvania and received a dual JD/MBA from Vanderbilt University, where he graduated with Beta Gamma Sigma honors.

Dr. Michael S. “Mickey” Urdea founded and is a Managing Partner for Halteres Associates, a biotechnology consulting firm. He also founded and served as Chief Executive Officer of Tethys Bioscience, a proteomics-based diagnostics company involved in preventative personalized medicine. Additionally, Dr. Urdea is a founder and the Chairman of Catalysis Foundation for Health, an organization addressing gaps in global healthcare caused by inefficiencies in disease diagnosis and monitoring. He serves as an expert consultant to the life sciences industry and is on the scientific advisory boards and boards of directors of a number of biotechnology, diagnostics, venture capital and philanthropic organizations. Prior to his current business activities, Dr. Urdea founded the Nucleic Acid Diagnostics group at Chiron Corporation, and with colleagues, invented branched DNA molecules for amplification of signal in nucleic acid complexes. Application of this technology resulted in the first commercial products for quantification of human hepatitis B, hepatitis C, and human immunodeficiency viruses (HBV, HCV, and HIV, respectively). He then became business head of the Molecular Diagnostics group and Chief Scientific Officer at Bayer Diagnostics. He was also a member of the Bill and Melinda Gates Foundation Diagnostic Forum. Dr. Urdea is an author on nearly 200 peer-reviewed scientific publications, nearly 300 abstracts and international scientific presentations, and more than 100 issued and pending patents. He received his BS in Biology and Chemistry from Northern Arizona University in Flagstaff and his Ph.D in Biochemistry from Washington State University.
 
 
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Executive Officers
 
The information under the heading “Executive Officers of the Registrant” in Item 1 of Part I of this Annual Report on Form 10-K is incorporated herein by this reference.

Section 16(a) Beneficial Ownership Reporting Compliance
 
Section 16(a) of the Exchange Act requires the Company’s executive officers and directors, and persons who own more than 10% of the Company’s Common Stock, to file reports of ownership and changes in ownership on Forms 3, 4 and 5 with the SEC.
 
Based solely on the Company’s review of the copies of such Forms and written representations from certain reporting persons, the Company believes that all filings required to be made by the Company’s Section 16(a) reporting persons during the Company’s fiscal year ended December 31, 2013 were made on a timely basis, except one outside investor.
 
Code of Ethics

Pursuant to Section 406 of the Sarbanes-Oxley Act of 2002, we have adopted a Code of Ethics for senior financial officers that applies to our principal executive officer, principal financial officer, principal accounting officer, controller, and other persons performing similar functions. A copy of the code of ethics is posted on, and may be obtained free of charge from our Internet website at http://www.pressurebiosciences.com.  If we make any amendments to this Code of Ethics or grant any waiver, including any implicit waiver, from a provision of this Code of Ethics to our principal executive officer, principal financial officer, principal accounting officer, controller, or other persons performing similar functions, we will disclose the nature of such amendment or waiver, the name of the person to whom the waiver was granted and the date of waiver in a Current Report on Form 8-K.

Corporate Governance

Term of Office

       Our directors are appointed for a three-year term to hold office until the annual general meeting of our shareholders or until removed from office in accordance with our bylaws. Our officers are appointed by our board of directors and hold office until removed by the board.
Audit Committee

The Audit Committee was established in accordance with Section 3(a)(58)(A) of the Securities Exchange Act of 1934.  Messrs. Pollack (chairman), Mangiardi and Peterson are currently the members of the Audit Committee.

The Board of Directors has determined that Mr. Pollack qualifies as an “audit committee financial expert” as defined in Item 407(d)(5) of Regulation S-K and is “independent” as defined by SEC and OTC Market rules.

The Audit Committee operates pursuant to a written charter (the “Audit Committee Charter”), a current copy of which is publicly available on the investor relations portion of the Company’s website at www.pressurebiosciences.com. Under the provisions of the Audit Committee Charter, the primary functions of the Audit Committee are to assist the Board of Directors with the oversight of (i) the Company’s financial reporting process, accounting functions, and internal controls, and (ii) the qualifications, independence, appointment, retention, compensation, and performance of the Company’s independent registered public accounting firm. The Audit Committee is also responsible for the establishment of “whistle-blowing” procedures, and the oversight of other compliance matters.

Compensation Committee

The Board of Directors has a Compensation Committee, consisting of Messrs. Peterson, Pollack and Mangiardi. The Compensation Committee’s duties include (i) reviewing and approving our executive compensation, (ii) reviewing the recommendations of the president and chief executive officer regarding the compensation of our executive officers, (iii) evaluating the performance of the president and chief executive officer, (iv) overseeing the administration and approval of grants of stock options and other equity awards under our equity incentive plans, and (v) recommending compensation for our board of directors and each committee thereof for review and approval by the board of directors. The Compensation Committee operates pursuant to a written charter, a current copy of which is publicly available on the investor relations portion of our website at www.pressurebiosciences.com.

 
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Involvement in Certain Legal Proceedings
 
To the best of our knowledge, none of our directors or executive officers has, during the past ten years:

been convicted in a criminal proceeding or been subject to a pending criminal proceeding (excluding traffic violations and other minor offenses);
had any bankruptcy petition filed by or against the business or property of the person, or of any partnership, corporation or business association of which he was a general partner or executive officer, either at the time of the bankruptcy filing or within two years prior to that time;
been subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction or federal or state authority, permanently or temporarily enjoining, barring, suspending or otherwise limiting, his involvement in any type of business, securities, futures, commodities, investment, banking, savings and loan, or insurance activities, or to be associated with persons engaged in any such activity;
been found by a court of competent jurisdiction in a civil action or by the Securities and Exchange Commission or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended, or vacated;
been the subject of, or a party to, any federal or state judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated (not including any settlement of a civil proceeding among private litigants), relating to an alleged violation of any federal or state securities or commodities law or regulation, any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order, or any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or
been the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange Act), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act), or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.

 Except as set forth in our discussion below in “Certain Relationships and Related Transactions,” none of our directors or executive officers has been involved in any transactions with us or any of our directors, executive officers, affiliates or associates which are required to be disclosed pursuant to the rules and regulations of the Commission.
 
 
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ITEM 11.    EXECUTIVE COMPENSATION
 
Executive Officer Compensation
 
Summary Compensation Table
 
The Summary Compensation Table below sets forth the total compensation paid or earned for the fiscal years ended December 31, 2013 and 2012 for: (i) each individual serving as our chief executive officer (“CEO”) or acting in a similar capacity during any part of fiscal 2013; and (ii) the other two most highly paid executive officers (collectively, the “Named Executive Officers”) who were serving as executive officers at the end of fiscal 2013.
 
Name and Principal Position
Fiscal
   Year
 
Salary(1)
   
Bonus
   
Stock Awards
   
Option
Awards(2)
   
Non-Qualified Deferred Compensation Earning
   
All other
Compensation(3)
   
Total
 
                                             
Richard T. Schumacher
2013
  $ 294,250     $ -     $ -     $ 26,497     $ -     $ 11,524     $ 332,271  
President, CEO
2012
    286,190       -       -       4,800       -       100,692       391,682  
                                                           
Edmund Ting, Ph.D
2013
    197,600       -       -       19,078       -       1,670       218,348  
Senior Vice President of
2012
    202,160       -       -       4,800       -       1,304       208,264  
Engineering                                                          
                                                           
Alexander
2013
    165,600       -       -       15,898       -       7,655       189,153  
Lazarev, Ph.D
2012
    175,103       -       -       4,800       -       7,501       187,404  
Vice President of                                                          
Research and                                                          
Development                                                          
 

(1) Salary refers to base salary compensation paid through our normal payroll process. No bonus was paid to any named executive officer for 2013 or 2012.
 
(2) Amounts shown do not reflect compensation received by the Named Executive Officers. Instead, the amounts shown are the aggregate grant date fair value as determined pursuant to FASB ASC 718, Compensation-Stock Compensation. Please refer to Note 2, xiii, “Accounting for Stock-Based Compensation” in the accompanying Notes to Consolidated Financial Statements for the fiscal year ended December 31, 2013, for the relevant assumptions used to determine the valuation of stock option grants.
 
(3) “All Other Compensation” includes our Company match to the executives’ 401(k) contribution and premiums paid on life insurance for the executives. Both of these benefits are available to all of our employees. In the case of Mr. Schumacher, “All Other Compensation” also includes $8,379 in premiums we paid for a life insurance policy to which Mr. Schumacher’s wife is the beneficiary, “All Other Compensation” for Dr. Lazarev includes $6,000 paid to Dr. Lazarev in lieu of his participation in the medical benefit plan offered by the Company.
 
 
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Outstanding Equity Awards at Fiscal Year End
 
The following table sets forth certain information regarding outstanding stock options awards for each of the Named Executive Officers as of December 31, 2013.
 
   
Option Awards
         
Name
 
Number of Securities Underlying Unexercised Options
Exercisable
   
Number of Securities Underlying Unexercised Options
Unexercisable (1)
   
Option Exercise Price
($)
 
Option Expiration Date
                     
Richard T. Schumacher
    75,000       -     $ 1.00  
6/17/2015
President, CEO
    30,000       -     $ 1.00  
3/30/2016
      70,000       -     $ 1.00  
2/12/2017
      75,000       -     $ 0.60  
3/12/2019
      8,438       6,562     $ 1.00  
9/09/2021
      13,125       16,875     $ 0.60  
3/13/2022
      59,375       15,625  (2)   $ 0.40   5/14/2023
                           
Edmund Y. Ting, Ph.D
    60,000       -     $ 1.00  
4/24/2016
Senior Vice President of Engineering
    12,000       -     $ 1.00  
3/30/2016
      42,000       -     $ 1.00  
2/12/2017
      8,438       6,562     $ 1.00  
9/09/2021
      7,656       9,844     $ 0.60  
3/13/2022
      42,750       11,250 (2)   $ 0.40   5/14/2023
                           
Alexander V. Lazarev, Ph.D
    50,000       -     $ 1.00  
6/17/2015
Vice President of Research & Development
    10,000       -     $ 1.00  
3/30/2016
      35,000       -     $ 0.60  
2/12/2017
      8,438       6,562     $ 1.00  
9/09/2021
      6,563       8,437     $ 0.60  
3/13/2022
      35,625       9,375 (2)    $ 0.40  
5/14/2023
 

(1) All unvested stock options listed in this column were granted to the Named Executive Officer pursuant to our 2005 Equity Incentive Plan. All options expire ten years after the date of grant. Unvested stock options become fully vested and exercisable upon a change of control of our company.
 
(2) Options to purchase shares of Common Stock were granted on May 14, 2013 to each of the Named Executive Officers, of which 50% of the stock options will vest immediately on the date of grant while the remainder will vest monthly over the remaining one year vesting period.
 
 
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Retirement Plan
 
All employees, including the named executive officers, may participate in our 401(k) Plan. Under the 401(k) Plan, employees may elect to make before tax contributions of up to 60% of their base salary, subject to current Internal Revenue Service limits. The 401(k) Plan does not permit an investment in our Common Stock. We match employee contributions up to 50% of the first 2% of the employee’s earnings. Our contribution is 100% vested immediately.

       Severance Arrangements

Each of Mr. Schumacher, Dr. Ting, Dr. Lazarev, and Dr. Lawrence, executive officers of the Company, are entitled to receive a severance payment if terminated by us without cause. The severance benefits would include a payment in an amount equal to one year of such executive officer’s annualized base salary compensation plus accrued paid time off. Additionally, the officer will be entitled to receive medical and dental insurance coverage for one year following the date of termination.

Change-in-Control Arrangements
 
Pursuant to severance agreements with each of Mr. Schumacher, Dr. Ting, Dr. Lazarev and Dr. Lawrence, each such executive officers, is entitled to receive a change of control payment in an amount equal to one year (other than Mr. Schumacher) of such executive officer’s annualized base salary compensation, accrued paid time off, and medical and dental coverage, in the event of a change of control of our company. In the case of Mr. Schumacher, his payment is equal to two years of annualized base salary compensation, accrued paid time off, and two years of medical and dental coverage.
 
Pursuant to our 2005 Equity Incentive Plan, any unvested stock options held by a named executive officer will become fully vested upon a change in control (as defined in the 2005 Equity Incentive Plan) of our company.
 
Director Compensation and Benefits
 
The following table sets forth certain information regarding compensation earned or paid to our directors during fiscal 2013.
 
Name
 
Fees Paid in Cash (1)
   
Fees Paid in Stock (1)
   
Option Awards (2)(3)
   
Total
 
Jeffrey N. Peterson (a,b)
  $ 17,250     $ 7,292       -     $ 25,542  
Vito J. Mangiardi (b)
    15,000       4,167       -       19,167  
Kevin A. Pollack (b)
    15,000       4,167       -       19,167  
Dr. Mickey Urdea (a)
    25,000       22,500       12,137       59,637  

 
 
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Our non-employee directors receive the following compensation for service as a director:
 
(1) Each director earned a quarterly stipend of (a) $7,500 (the quarterly stipend was increased from $5,000 beginning February 2013) for attending meetings of the full board of directors (whether telephonic or in-person) and attending committee meetings in 2013. Mr. Peterson currently earns $8,625 per quarter as chairman of the board of directors and Dr. Urdea receives $5,000 per quarter for serving on the scientific advisory committee.  We issued an aggregate of 95 shares of the Company’s Series J Convertible Preferred Stock in February 2013 to current board members for payment of board fees owed. Amounts shown under the heading “Fees Paid in Stock” reflect compensation received by the directors grant date fair value of the stock issued in lieu of payment of director fees as determined by the Company’s closing stock price in February 6, 2013. There is no limit to the number of board of directors or committee meetings that may be called.

(2) Amounts shown do not reflect compensation received by the directors. Instead, the amounts shown are the aggregate grant date fair value as determined pursuant to FASB ASC 718, Compensation-Stock Compensation. Please refer to Note 2, xiii, “Accounting for Stock-Based Compensation” in the accompanying Notes to the Consolidated Financial Statements for the fiscal year ended December 31, 2013, for the relevant assumptions used to determine the valuation of stock option grants.

(3) The following table shows the total number of outstanding stock options as of December 31, 2013 that have been issued as director compensation.

Name
 
Aggregate Number of Stock Options Outstanding
 
Jeffrey N. Peterson
    63,750  
 Michael S.  Urdea
    37,500  
Vito J. Mangiardi
    50,000  
Kevin A. Pollack
    50,000  

Report from Compensation Committee

General

Messrs. Peterson, Pollack and Mangiardi are currently the members of the Compensation Committee. The Compensation Committee operates pursuant to a written charter, a current copy of which is publicly available on the investor relations portion of our website at www.pressurebiosciences.com. The primary functions of the Compensation Committee include (i) reviewing and approving our executive compensation, (ii) reviewing the recommendations of the president and chief executive officer regarding the compensation of our executive officers, (iii) evaluating the performance of the president and chief executive officer, (iv) overseeing the administration and approval of grants of stock options and other equity awards under our equity incentive plans, and (v) recommending compensation for our board of directors and each committee thereof for review and approval by the board of directors.

The Compensation Committee may form and delegate authority to one or more subcommittees as it deems appropriate from time to time under the circumstances (including (a) a subcommittee consisting of a single member and (b) a subcommittee consisting of at least two members, each of whom qualifies as a “non-employee director,” as such term is defined from time to time in Rule 16b-3 promulgated under the Securities Exchange Act of 1934, and an “outside director,” as such term is defined from time to time in Section 162(m) of the Internal Revenue Code of 1986, as amended, and the rules and regulations there under).
 
 
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Compensation Objectives
 
In light of the relatively early stage of commercialization of our products, we recognize the importance of attracting and retaining key employees with sufficient experience, skills, and qualifications in areas vital to our success, such as operations, finance, sales and marketing, research and development, engineering, and individuals who are committed to our short- and long-term goals. The Compensation Committee has designed our executive compensation programs with the intent of attracting, motivating, and retaining experienced executives and, subject to our limited financial resources, rewarding them for their contributions by offering them a competitive base salary, potential for annual cash incentive bonuses, and long-term equity-based incentives, typically in the form of stock options. The Compensation Committee strives to balance the need to retain key employees with financial prudence given our history of operating losses, limited financial resources and the early stage of our commercialization.
 
Executive Officers and Director Compensation Process
 
The Compensation Committee considers and determines executive compensation according to an annual objective setting and measurement cycle. Specifically, corporate goals for the year are initially developed by our executive officers and are then presented to our board of directors and Compensation Committee for review and approval. Individual goals are intended to focus on contributions that facilitate the achievement of the corporate goals. Individual goals are first proposed by each executive officer, other than the president and CEO, then discussed by the entire senior executive management team and ultimately compiled and prepared for submission to our board of directors and the Compensation Committee, by the president and chief executive officer. The Compensation Committee sets and approves the goals for the president and chief executive officer. Generally, corporate and individual goals are set during the first quarter of each calendar year. The objective setting process is coordinated with our annual financial planning and budgeting process so our board of directors and Compensation Committee can consider overall corporate and individual objectives in the context of budget constraints and cost control considerations. Annual salary increases, bonuses, and equity awards, such as stock option grants, if any, are tied to the achievement of these corporate and individual performance goals as well as our financial position and prospects.
 
Under the annual performance review program, the Compensation Committee evaluates individual performance against the goals for the recently completed year. The Compensation Committee’s evaluation generally occurs in the first quarter of the following year. The evaluation of each executive (other than the president and chief executive officer) begins with a written self-assessment submitted by the executive to the president and chief executive officer. The president and chief executive officer then prepares a written evaluation based on the executive’s self-assessment, the president and chief executive officer’s evaluation, and input from others within the Company. This process leads to a recommendation by the president and chief executive officer for a salary increase, bonus, and equity award, if any, which is then considered by the Compensation Committee. In the case of the president and chief executive officer, the Compensation Committee conducts his performance evaluation and determines his compensation, including salary increase, bonus, and equity awards, if any. We generally expect, but are not required, to implement salary increases, bonuses, and equity awards, for all executive officers, if and to the extent granted, by April 1 of each year.
 
Non-employee director compensation is set by our board of directors upon the recommendation of the Compensation Committee. In developing its recommendations, the Compensation Committee is guided by the following goals: compensation should be fair relative to the required services for directors of comparable companies in our industry and at our company’s stage of development; compensation should align directors’ interests with the long-term interest of stockholders; the structure of the compensation should be simple, transparent, and easy for stockholders to understand; and compensation should be consistent with the financial resources, prospects, and competitive outlook for the Company.
 
In evaluating executive officer and director compensation, the Compensation Committee considers the practices of companies of similar size, geographic location, and market focus. In order to develop reasonable benchmark data the Compensation Committee has referred to publicly available sources such as www.salary.com and the BioWorld Survey. While the Compensation Committee does not believe benchmarking is appropriate as a stand-alone tool for setting compensation due to the unique aspects of our business objectives and current stage of development, the Compensation Committee generally believes that gathering this compensation information is an important part of its compensation-related decision making process.
 
The Compensation Committee has the authority to hire and fire advisors and compensation consultants as needed and approve their fees. No advisors or compensation consultants were hired or fired in fiscal 2013. The Compensation Committee is also authorized to delegate any of its responsibilities to sub committees or individuals as it deems appropriate. The Compensation Committee did not delegate any of its responsibilities in fiscal 2013.
 
 
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ITEM 12.   SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
 
Beneficial Ownership Information
 
The following table sets forth certain information as of January 31, 2014 concerning the beneficial ownership of  Common Stock for: (i) each director and director nominee, (ii) each Named Executive Officer in the Summary Compensation Table under “Executive Compensation” above, (iii) all executive officers and directors as a group, and (iv) each person (including any “group” as that term is used in Section 13(d)(3) of the Exchange Act) known by us to be the beneficial owner of 5% or more of our  Common Stock. The address for each of the persons below who are beneficial owners of 5% or more of our Common Stock is our corporate address at 14 Norfolk Avenue, South Easton, MA 02375.
 
Beneficial ownership has been determined in accordance with the rules of the SEC and is calculated based on 12,024,267 shares of our Common Stock issued and outstanding as of January 31, 2014. Shares of Common Stock subject to options, warrants, preferred stock or other securities convertible into Common Stock that are currently exercisable or convertible, or exercisable or convertible within 60 days of January 31, 2014, are deemed outstanding for computing the percentage of the person holding the option, warrant, preferred stock, or convertible security but are not deemed outstanding for computing the percentage of any other person.
 
Except as indicated by the footnotes below, we believe, based on the information furnished to us, that the persons and entities named in the table below have sole voting and investment power with respect to all shares of Common Stock that they beneficially own.
 
Name
 
Number of Shares of Common Stock Beneficially Owned
   
Percent of Class
 
             
Richard T. Schumacher (1)
    1,551,104       12.0 %
Jeffrey  N. Peterson, MS (2)
    385,726       3.1 %
Kevin A. Pollack, Esq. MBA (3)
    499,500       4.0 %
Vito J. Mangiardi, MBA (4)
    346,000       2.8 %
Michael S. Urdea, Ph D (5)
    311,500       2.5 %
Edmund Y. Ting, Ph.D (6)
    205,773       1.7 %
Alexander V. Lazarev, Ph.D  (7)
    170,891       1.4 %
All other officers
    305,743       2.7 %
                 
All Executive Officers and Directors as a Group (nine persons)
    3,776,237       25.1 %
 
1)
Includes (i) 343,125 shares of Common Stock issuable upon exercise of options; (ii) 428,675 shares of Common Stock issuable upon the exercise of warrants.  Amount does not include 20,162 shares of Common Stock held by Mr. Schumacher’s minor son as his wife exercises all voting and investment control over such shares.
 
2)
Includes (i) 63,750 shares of  Common Stock issuable upon exercise of options, and (ii) 191,000 shares of  Common Stock issuable upon exercise of warrants.

3)
Includes (i) 50,000 shares of Common Stock issuable upon exercise of options, and (ii) 241,000 shares of Common Stock issuable upon the exercise of warrants

4)
Includes (i) 50,000 shares of Common Stock issuable upon exercise of options, and (ii) 183,000 shares of Common Stock issuable upon the exercise of warrants.

5)
Includes (i) 37,500 shares of Common Stock issuable upon exercise of options, and (ii) 167,000 shares of Common Stock issuable upon the exercise of warrants.

6)
Includes (i) 181,625 shares of Common Stock issuable upon exercise of options, and (ii) 8,290 shares of Common Stock issuable upon the exercise of warrants.

7)
Includes (i) 153,125 shares of Common Stock issuable upon exercise of options, and (ii) 6,705 shares of Common Stock issuable upon the exercise of warrants.

 
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Equity Compensation Plan Information

We maintain a number of equity compensation plans for employees, officers, directors and other entities and individuals whose efforts contribute to our success. The table below sets forth certain information as of our fiscal year ended December 31, 2013 regarding the shares of our Common Stock available for grant or granted under our equity compensation plans.
 
Plan Category
 
Number of securities to be issued upon exercise of outstanding options
   
Weighted-average exercise price of outstanding options
   
Number of securities remaining available for future issuance under equity compensation plans
 
Equity compensation plans approved by security holders(1)
    1,771,708     $ 0.71       61,292  
 

(1) Includes the following plans: 1999 Non-Qualified Stock Option Plan and 2005 Equity Incentive Plan.

ITEM 13.   CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS; AND DIRECTOR INDEPENDENCE.

Board Independence

Our board of directors has reviewed the qualifications of each of Messrs. Peterson, Mangiardi and Pollack, constituting more than a majority of our directors and has affirmatively determined that each individual is “independent” as such term is defined under the current listing standards of the OTC Markets. The board of directors has determined that none of these directors has a material relationship with us that would interfere with the exercise of independent judgment. In addition, each member of the Audit Committee is independent as required under Section 10A(m)(3) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
 
ITEM 14.   PRINCIPAL ACCOUNTING FEES AND SERVICES
Independent Registered Public Accounting Fees
 
The following is a summary of the fees billed to the Company by Marcum LLP, the Company’s current independent registered public accounting firm, for the fiscal year ended December 31, 2013 and 2012:
 
   
Fiscal 2013 Fees
   
Fiscal 2012 Fees
 
Audit Fees
  $ 120,000     $ 143,250  
Audit-Related Fees
    23,661       51,500  
Tax and Other Fees
    -       -  
    $ 143,661     $ 203,750  
 
Audit Fees. Consists of aggregate fees billed for professional services rendered for the audit of the Company’s consolidated financial statements and review of the interim consolidated financial statements included in quarterly reports, as well as services that are normally provided by the independent registered public accounting firm in connection with statutory and regulatory filings or engagements.
 
Audit-Related Fees. Consists of aggregate fees billed for assurance and related services that are reasonably related to the performance of the audit or review of the Company’s consolidated financial statements and are not reported under “Audit Fees.” Fees billed by Marcum for 2012 were fees associated with a consent delivered in connection with the Company’s Registration Statement on Form S-3 and Registration Statement on Form S-1.
 
Audit Committee Policy on Pre-Approval of Services
 
The Audit Committee’s policy is to pre-approve all audit and permissible non-audit services provided by the independent registered public accounting firm. These services may include audit services, audit-related services, tax services, and other services. Pre-approval is generally provided for up to one year. The Audit Committee may also pre-approve particular services on a case-by-case basis.
 
 
89

 
PART IV
 
Item 15 Exhibits and Financial Statement Schedules.
 
Exhibit No.
 
Reference
3.1
Restated Articles of Organization of the Company
A-3.1**
3.2
Articles of Amendment to Restated Articles of Organization of the Company
B-3.1**
3.3
Articles of Amendment to Restated Articles of Organization of the Company, as amended
O-3.1**
3.4
Articles of Amendment to Restated Articles of Organization of the Company, as amended
L-3.1**
3.5
Articles of Amendment to Restated Articles of Organization of the Company, as amended
P-3.1**
3.6
Articles of Amendment to Restated Articles of Organization of the Company, as amended
U-3.1**
3.7
Amended and Restated By-Laws of the Company
A-3.2**
3.8 Amendment to Amended and Restated By-Laws of the Company C-3.3**
3.9 Articles of Amendment to Restated Articles of Organization of the Company, as amended W-3.1
3.10 Articles of Amendment to Restated Articles of Organization of the Company, as amended X-3.1
3.11 Articles of Amendment to Restated Articles of Organization of the Company, as amended Z-3.1
4.1
Specimen Certificate for Shares of the Company’s  Common Stock
D-4.1**
4.2
Description of Capital Stock (contained in the Amended and Restated Articles of Organization, as amended, of the Company filed as Exhibits 3.1, 3.2, 3.3, 3.4, 3.5, 3.6 and 3.7)
A-3.1 & 3.2, B-31, O-31, L-31, P-31 and U.31**
4.3
Rights Agreement dated as of February 27, 2003 between the Company and Computershare Trust Company, Inc.
E-4**
4.4
Amendment No. 1 to Rights Agreement dated April 16, 2004 between the Company and Computershare Trust Company, Inc.
F-4**
4.5
Amendment No. 2 to Rights Agreement dated November 8, 2011 between the Company and Computershare Trust N.A.
U-4.2**
4.6 Securities Purchase Agreement dated November 21, 2007 between the Company and the purchasers named therein G-4.9**
4.7
Registration Rights Agreement dated November 21, 2007 between the Company and the purchasers named therein
G-4.10**
4.8
Securities Purchase Agreement dated February 12, 2009 between the Company and the purchasers named therein
L-4.1**
4.9
Form of 15-Month Preferred Stock Warrant
L-4.3**
4.10
Form of 30-Month  Common Stock Purchase Warrant
L-4.4**
4.11
Amendment No. 1 to 30-Month  Common Stock Purchase Warrant
Q-4.2**
4.12 Amendment No. 2 to 30-Month  Common Stock Purchase Warrant S-4.1**
4.13 Registration Rights Agreement dated February 12, 2009 between the Company and the purchasers named therein L-4.5**
4.14
Securities Purchase Agreement dated November 18, 2009 between the company and the purchasers named therein
O-4.1**
4.15
Registration Rights Agreement dated November 18, 2009 between the Company and the purchasers named therein
O-4.3**
4.16
Series B Preferred Stock Warrant
O-4.2**
 
 
90

 
 
Exhibit No.
 
Reference
4.17
Amendment No. 1 to Series B Convertible Preferred Stock Purchase Warrant
Q-4.1**
4.18
Amendment No. 2 to Series B Convertible Preferred Stock Purchase Warrant
S-4.2**
4.19
Securities Purchase Agreement dated April 8, 2011 between the Company and the Purchasers Named Therein
P-4.1**
 
Registration Rights Agreement dated April 8, 2011 between the Company and the Purchasers Named Therein
4.2
Amendment No. 1 to Securities Purchase Agreement dated June 21, 2011, amending Securities Purchase Agreement dated April 8, 2011 between the Company and the Purchasers Named Therein
P-4.3**
 
Form of  Common Stock Purchase Warrant
4.21
Form of Warrant Issued to Lenders
R-4.1**
 
Form of Promissory Note Issued to Lenders
 
Form of  Common Stock Purchase Warrant
4.22
Form of Warrant
P-4.2**
4.23
Securities Purchase and Exchange Agreement, dated December 28, 2012
T-4.1**
4.24
Securities Purchase and Exchange Agreement, dated December 28, 2012
T-4.2**
4.25
Form of Warrant
U-4.1**
4.26
Registration Rights Agreement, dated February 6, 2013 between the Company and Purchasers named therein
V-4.1**
4.27
10% Convertible Debenture, issued on June 7, 2013 for a Purchase price of $250.00
W-4.2
4.28
Securities Purchase and Exchange Agreement, dated December 12, 2013
X-4.1
4.29
Form of Warrant, initial exercise date December 12, 2013
X-4.2
4.3
Registration Rights Agreement, dated December 12, 2013
X-4.3
 
1999 Non-Qualified Stock Option Plan*
Y-4.1
4.31
 
Z-4.1
4.32
 
Z-4.2
4.33
 
Z-4.3
4.34
 
H**
10.1
   
10.2
1999 Employee Stock Purchase Plan*
 H**
10.3
2005 Equity Incentive Plan.*
I-99.1**
10.4
Amendment No. 1 to 2005 Equity Incentive Plan*
M-10.1**
10.5
Description of Compensation for Certain Directors*
N-10.7**
10.6
Severance Agreement between the registrant and Richard T. Schumacher*
N-10.6**
10.7
Form of Severance Agreement including list of officers to whom provided*
N-10.7**
10.8
Consent Agreement, dated May 29, 2007, by and among the registrant, PBI Source Scientific, Inc., Source Scientific, LLC, BIT Analytical Instruments, Inc., Richard W. Henson and Bruce A. Sargeant.
J-10.1**
10.9
Asset Purchase Agreement dated April 16, 2004 between the Company, BBI Biotech Research Laboratories, Inc. and SeraCare Life Sciences, Inc.
F-1**
10.1
Technology Transfer and Patent Assignment Agreement dated October 7, 1996, between Bioseq, Inc. and BioMolecular Assays, Inc.
N-10.11**
 10.11
Amendment to Technology Transfer and Patent Assignment Agreement dated October 8, 1998 between Bioseq, Inc. and BioMolecular Assays, Inc.
N-10.12**
10.12
Nonexclusive License Agreement dated September 30, 1998 between Bioseq, Inc. and BioMolecular Assays, Inc.
N-10.13**
10.13
Agreement for Research Services dated February 1, 2006 by and between the registrant and the University of New Hampshire
K-10.1**
10.14
Placement Agency Agreement between the Placement agent and the Company, dated November 8, 2011
U-10.1**
 
Form of Securities Purchase Agreement
10.15
Form of Escrow Agreement, as amended
U-10.2**
10.16
Form of Securities Purchase Agreement
U-10.3**
10.17
Securities Purchase Agreement, dated June 7, 2013
V-3.1**
10.18
Consent of Independent Registered Public Accounting Firm (Marcum LLP)
Y-10.1
23.1
 
Filed herewith
     
31.1
Principal Executive Officer and Principal Financial Officer Certification Pursuant to Item 601(b)(31) of Regulation S-K, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Filed herewith
32.1
Principal Executive Officer and Principal Financial Officer Certification Pursuant to Item 601(b)(32) of Regulation S-K, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Filed herewith
101
Interactive Data File
Filed herewith
 
 
91

 
 
*Management contract or compensatory plan or arrangement.
**Previously filed as follows.
 
A
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Registration Statement on Form S-1 (Registration No. 333-10759) filed with the Commission on August 23, 1996.
B
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2004.
C
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2002.
D
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Annual Report on Form 10-KSB for the fiscal year ended December 31, 2004.
E
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission March 12, 2003.
F
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission April 16, 2004.
G
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Registration Statement on Form S-3 (Registration No. 333-148227) filed with the Commission on December 20, 2007.
H
We previously filed this exhibit as an appendix to the registrant’s proxy statement filed June 14, 1999.
I
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Registration Statement on Form S-8 (Reg. No. 333-128594) filed with the Commission on September 26, 2005.
J
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on June 1, 2007.
K
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on February 7, 2006.
L
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on February 18, 2009.
M
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on September 29, 2008.
N
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Annual Report on Form 10-K filed with the Commission on March 27, 2008.
O
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on November 19, 2009.
P
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on April 12, 2011.
Q
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on August 11, 2011.
R
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on June 21, 2011.
S
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on October 6, 2011.
T
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2011.
U
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on November 10, 2011.
V
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on February 9, 2012.
W
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on January 4, 2013.
X
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on February 13, 2013.
Y
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on June 13, 2013.
Z
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on December 12, 2013.

 
 
92

 
 
SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
     
Date: March 31, 2014
Pressure BioSciences, Inc.
     
 
By:
/s/ Richard T. Schumacher
 
Richard T. Schumacher
 
President and Chief Executive Officer
 
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacity and on the dates indicated.
 
Name
 
Capacity
 
Date
         
/s/ Richard T. Schumacher
Richard T. Schumacher
 
President, Chief Executive Officer, Treasurer, Clerk and Director (Principal Executive Officer)
 
March 31, 2014
         
/s/ Richard P. Thomley
Richard P. Thomley
 
Chief Financial Officer
(Principal Financial Officer)
 
March 31, 2014
         
/s/ Jeffrey N. Peterson
Jeffrey N. Peterson
 
Chairman of the Board of Directors
 
March 31, 2014
         
/s/ Mickey Urdea
Michael S.Urdea, Ph.D.
 
Director
 
March 31, 2014
         
/s/ Vito Mangiardi
Vito J. Mangiardi
 
Director
 
March 31, 2014
         
/s/ Kevin Pollack
Kevin A. Pollack
 
Director
 
March 31, 2014
 
93