Study to support differentiated efficacy of Vendaje® structural tissue allograft
POMPANO BEACH, FL / ACCESSWIRE / October 24, 2023 / BioStem Technologies Inc. (OTC PINK:BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental derived biologics for advanced wound care, today announced that the first site is now fully opened for its clinical trial, evaluating the Vendaje® tissue allograft in the treatment of diabetic foot ulcers (DFU).
Jason Matuszewski, Chief Executive Officer of BioStem, said, "This milestone signifies a significant moment in our journey. The initiation of a 100-patient trial not only provides invaluable real-world support for healthcare professionals but also underscores our commitment to deploying Vendaje in the treatment of patients with chronic wounds. Furthermore, it offers a platform to substantiate the inherent advantages of our proprietary BioREtain® process. Patient recruitment has already commenced at our primary site, and we anticipate the remaining four sites will be operational in the forthcoming months."
Diabetic foot ulcers are a widespread and highly serious complication, impacting around 15 percent of individuals with diabetes. Annually, over two million Americans in the U.S. develop diabetic foot ulcers, which are chronic wounds capable of resulting in amputation and, in severe cases, even the loss of a patient's life.
Current standards of care for managing persistent, challenging-to-heal wounds like diabetic foot ulcers often involve absorbable wound dressings. These dressings must create an environment conducive to healing, supporting the development of a structural framework, the growth of new blood vessels (angiogenesis), and the migration of skin cells across the wound bed.
BioStem's Vendaje allografts play a pivotal role by providing a scaffold for tissue healing. They encompass natural growth factors, extracellular matrix components, and anti-inflammatory cytokines known for their support in the body's healing processes. This clinical study is an opportunity for us to showcase the effectiveness of our products in a real-world clinical setting while also substantiating the distinctive advantages of our BioREtain process.
BioStem's structural tissue allograft product portfolio includes VENDAJE®, VENDAJE AC®, VENDAJE OPTIC® and AmnioWrap2TM.
About VendajeⓇ and AmnioWrap2TM
Vendaje and AmnioWrap2 are placental-derived, minimally manipulated dehydrated tissue allografts that serve as a protective covering for soft tissue wounds. The product is comprised of extracellular matrix scaffolding which provides mechanical protection and functional support for cell migration, growth factors that help modulate proliferation and angiogenesis, and anti-inflammatory cytokines that inhibit inflammatory effects, all critical to aiding the body's natural healing cascade
About BioStem Technologies, Inc. (OTC: BSEM):
BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain® processing method. BioREtain® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies' quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks ("AATB"). These systems and procedures are established per current Good Tissue Practices ("cGTP") and current Good Manufacturing Processes ("cGMP"). Our portfolio of quality brands includes AmnioWrap2™, VENDAJE®, VENDAJE AC®, and VENDAJE OPTIC®. Each BioStem Technologies placental allograft is processed at the Company's FDA registered and AATB accredited site in Pompano Beach, Florida. For more information, visit biostemtechnologies.com and follow us on Twitter and Linkedin.
Forward-Looking Statements:
Except for statements of historical fact, this release also contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified using words such as "forecast," "intend," "seek," "target," "anticipate," "believe," "expect," "estimate", "plan," "outlook," and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements with respect to the operations of the Company, strategies, prospects and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of any changes to the reimbursement levels for the Company's products; (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company's products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete;(4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company's ability to raise funds to expand its business; (6) the Company has incurred significant losses since inception and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company's ability to maintain production of its products in sufficient quantities to meet demand; and (10) the COVID-19 pandemic and its impact, if any, on the Company's fiscal condition and results of operations; You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.
BioStem Technologies, Inc.
Phone: 954-380-8342
Website: http://www.biostemtechnologies.com
E-Mail: info@biostemtech.com
Twitter: @BSEM_Tech
Facebook: BioStemTechnologies
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
646-863-6893
SOURCE: BioStem Technologies Inc.
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