Announces Additional FDA 510(k) Submission for the Use of the Renuvion® Dermal Handpiece in Dermatological Procedures Requiring Ablation and Resurfacing of the Skin
Apyx Medical Corporation (NASDAQ:APYX) (the “Company”), a maker of medical devices, and supplier and the developer of Helium Plasma Technology, marketed and sold as Renuvion® in the cosmetic surgery market and J-Plasma® in the hospital surgical market, today announced the publication of a peer-reviewed article in the journal, Lasers in Surgery and Medicine, the official journal of the American Society for Laser Medicine & Surgery, featuring the results of its U.S. IDE clinical study evaluating the Renuvion® Dermal Handpiece using Apyx’s Helium Plasma Technology for dermal resurfacing procedures. The Company also announced it has submitted a 510(k) premarket notification (“510(k) submission”) to the U.S. Food and Drug Administration (“FDA”), which is intended to obtain a general indication for use of the Renuvion® Dermal handpiece in dermatological procedures requiring ablation and resurfacing of the skin.
Summary of results of the U.S. IDE Clinical Study Evaluating Helium Plasma Technology for Dermal Resurfacing Procedures:
- The primary efficacy endpoint was achieved, with 100% of the study’s subjects achieving a ≥1-point improvement on the Fitzpatrick Wrinkle and Elastosis Scale (“FWS”) at the 90-day post-treatment visit.
The mean change in FWS from baseline to the 90-day post-treatment visit, as assessed by the study’s Independent Photographic Reviewers, was 3.6 points.
- 96.4% of subjects improved on average by at least 1 point, 92.7% of subjects improved by at least 2 points and 74.5% of subjects improved by at least 3 points.
- All three of the study’s Independent Photographic Reviewers correctly identified the 90-day post-treatment image in 100% of subjects, in pairs of baseline and 90-day images.
- Subjects’ satisfaction with the procedure at the 90-day visit (as assessed by the Patient Satisfaction Questionnaire) was positive: 96.4% were “happy with results of procedure” and 83.6% “would recommend procedure to a friend.”
No serious adverse events related to the study device or procedure occurred.
- 269 adverse events and expected treatment effects were reported: 99.3% were of “Mild” or “Moderate” severity and 81.8% were expected treatment effects. 60.6% resolved within 30 days post-treatment, 75.8% resolved by day 90 and 90.3% resolved by day 180 post-treatment.
- No treatment related adverse events were observed that are unique to the helium plasma technology or to energy-based skin rejuvenation treatments.
In the article, lead author J. David Holcomb, MD, (Kreithen Plastic Surgery and MedSpa) concluded: “high energy, double pass helium plasma dermal resurfacing is an effective treatment for moderate to severe wrinkles in patients with Fitzpatrick Skin Types I, II and III. Mean FWS improvement was more than 2 grades higher than that previously observed with other skin resurfacing technologies including nitrogen plasma skin regeneration and CO2 laser skin resurfacing.”
“Apyx Medical Corporation is excited to announce the publication of this peer-reviewed article in the journal, Lasers in Surgery and Medicine, which features the results of our IDE clinical study evaluating the use of our Renuvion® Technology in dermal resurfacing procedures,” said Charlie Goodwin, President and Chief Executive Officer. “This robust study supports the 510(k) premarket notification that remains under review by the FDA.”
Mr. Goodwin continued: “In addition to this submission, which is intended to obtain a specific clinical indication for treating wrinkles and rhytids, we are pleased to announce today that we submitted another 510(k) premarket notification to obtain a general indication for the dermal resurfacing procedure category. Pursuant to our regulatory strategy, both submissions are intended to enable Apyx Medical Corporation to market and sell the Renuvion® Dermal handpiece for this target procedure category, expanding our addressable market opportunity in the U.S. cosmetic surgery market. We look forward to working collaboratively with the FDA to facilitate their review process.”
Overview of the U.S. IDE Clinical Study Evaluating Helium Plasma Technology for Dermal Resurfacing Procedures
The study, titled High Energy, Double Pass Helium Plasma Dermal Resurfacing: A Prospective, Multicenter, Single Arm Clinical Study, was conducted by Holcomb et. al. and included 55 subjects enrolled at one of four investigational sites. The purpose of the study was to demonstrate the effectiveness and safety of high energy (40% power), double pass Helium Plasma Dermal Resurfacing (“HPDR”) treatment of facial skin. Full details of the U.S. IDE clinical study are available at clinicaltrials.gov (Identifier: NCT04185909).
To be eligible for inclusion in the study, subjects were required to have a facial wrinkle score ≥ 4 on the Fitzpatrick Wrinkle and Elastosis Scale, a Fitzpatrick Skin Scale score ≤ III and express their willingness to comply with protocol requirements. Subject’s forehead, nose, cheeks and perioral zones were treated with 2 passes of HPDR at 40% power and a helium gas flow rate of 4 L/min. Subject’s periorbital zone was treated at 20% power and a helium gas flow rate of 4 L/min with 1 or 2 passes and the jawline/mandibular border zone was treated at 20% to 40% power and a helium gas flow rate of 4 L/min with 1 or 2 passes, based upon the discretion of the investigators.
Subject’s wrinkle severity was assessed by three blinded, board-certified dermatologists or plastic surgeons (“Independent Photographic Reviewers”) using the Fitzpatrick Wrinkle and Elastosis Scale (“FWS”) at baseline and at the 90-day post-treatment visit. The study’s primary efficacy endpoint was the proportion of subjects achieving individual treatment success, defined as a ≥1-point improvement on the FWS at the 90-day post-treatment visit by at least two out of the three blinded IPRs. An additional efficacy endpoint included correctly identifying 90-day post-treatment images from a pair of baseline and 90-day post-treatment images by at least 2 of 3 blinded IPRs.
The peer-reviewed article in the journal, Lasers in Surgery and Medicine, can be accessed via the following website: http://doi.org/10.1002/lsm.23524
About Apyx Medical Corporation:
Apyx Medical Corporation is an advanced energy technology company with a passion for elevating people’s lives through innovative products in the cosmetic and surgical markets. Known for its innovative Helium Plasma Technology, Apyx is solely focused on bringing transformative solutions to the physicians and patients it serves. The company’s Helium Plasma Technology is marketed and sold as Renuvion® in the cosmetic surgery market and J-Plasma® in the hospital surgical market. Renuvion® offers surgeons and physicians a unique ability to provide controlled heat to the tissue to achieve their desired results. The J-Plasma® system allows surgeons to operate with a high level of precision while minimizing unintended tissue trauma. The Company also leverages its deep expertise and decades of experience in unique waveforms through original equipment manufacturing (OEM) agreements with other medical device manufacturers. For further information about the Company and its products, please refer to the Apyx Medical Corporation website at www.ApyxMedical.com.
Cautionary Statement on Forward-Looking Statements:
Certain matters discussed in this release and oral statements made from time to time by representatives of the Company may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the Company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that its expectations will be achieved.
Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the Company’s ability to control or predict. Important factors that may cause actual results to differ materially and that could impact the Company and the statements contained in this release can be found in the Company’s filings with the Securities and Exchange Commission including the Company’s Report on Form 10-K for the year ended December 31, 2020. For forward-looking statements in this release, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The Company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.
Investor Relations Contact:
Westwicke on behalf of Apyx Medical Corporation
Mike Piccinino, CFA