CLEARWATER, Florida–(BUSINESS WIRE)–Apyx Medical Corporation (NASDAQ:APYX) (the “Company”), manufacturer of medical devices, supplier and developer of Helium Plasma technology, marketed and sold under the name Renuvion® in the cosmetic surgery market and J-Plasma® in the hospital surgery 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, presenting the results of its US IDE clinical study evaluating the Renuvion® dermal handpiece using Apyx’s helium plasma technology for dermal resurfacing procedures. The company also announced that it has submitted a 510(k) premarket notification (“510(k) submission”) to the U.S. Food and Drug Administration (“FDA”), which seeks general guidance for the use of the Renuvion® Dermal Handpiece in dermatological procedures requiring the ablation and resurfacing of the skin.
Summary of results from the US IDE clinical study evaluating helium plasma technology for skin resurfacing procedures:
The primary efficacy endpoint was met, with 100% of study subjects achieving an improvement of ≥1 point on the Fitzpatrick Wrinkle and Elastosis Scale (“FWS”) during 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.
The study’s three independent photographic reviewers correctly identified the 90-day post-processing image in 100% of subjects, in reference and 90-day image pairs.
Subjects’ satisfaction with the procedure at the 90-day visit (as assessed by the Patient Satisfaction Questionnaire) was positive: 96.4% were “satisfied with the results of the procedure” and 83 .6% “would recommend the 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 were unique to helium plasma technology or 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 I, II, and III skin types. The average improvement in FWS was more than 2 degrees greater than previously seen with other skin resurfacing technologies, including nitrogen plasma skin regeneration and CO2 laser skin resurfacing.
“Apyx Medical Corporation is delighted to announce the publication of this peer-reviewed article in the journal, Lasers in surgery and medicine, which presents the results of our IDE clinical study evaluating the use of our Renuvion® technology in dermal resurfacing procedures,” said Charlie Goodwin, President and CEO. “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 seeking a specific clinical indication for the treatment of fine lines and wrinkles, we are pleased to announce today that we have submitted another 510(k) premarket notification seeking a general indication for the category of dermal resurfacing procedures. In line with our regulatory strategy, both submissions are intended to enable Apyx Medical Corporation to market and sell the Renuvion® Dermal handpiece for this category of targeted procedures, thereby expanding our market opportunity in the US cosmetic surgery market. . We look forward to working with the FDA to facilitate their review process.
Overview of the US IDE Clinical Study Evaluating Helium Plasma Technology for Dermal Resurfacing Procedures
The study, titled Double-Pass High-Energy 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 research sites. The purpose of the study was to demonstrate the efficacy and safety of a high-energy (40% power), double-pass helium plasma dermal resurfacing (“HPDR”) treatment of the skin of the face. Full details of the IDE clinical study in the United States are available at clinicaltrials.gov (ID: NCT04185909).
To be eligible for inclusion in the study, subjects had to have a Fitzpatrick Wrinkle and Elastosis Scale facial wrinkle score ≥ 4, a Fitzpatrick Skin Scale score ≤ III, and express willingness to comply with the requirements of the protocol. The subject’s forehead, nose, cheeks and perioral areas were treated with 2 passes of HPDR at 40% power and a helium gas flow of 4 L/min. The subject’s periorbital area was treated at 20% power and helium gas flow of 4 L/min with 1 or 2 passes and the frontal jaw/mandibular area was treated at 20% power at 40% and a helium gas flow of 4 L/min with 1 or 2 passes, at the discretion of the investigators.
The severity of subject’s wrinkles was assessed by three blind board-certified dermatologists or plastic surgeons (“independent photographic reviewers”) using the Fitzpatrick Scale of Wrinkles and Elastosis (“FWS”) at baseline and during of the 90-day post-treatment visit. The primary efficacy endpoint of the study was the proportion of subjects achieving individual treatment success, defined as ≥1 point improvement in FWS at the 90-day post-treatment visit by at least two of the three blind IPRs. An additional efficacy endpoint included correct identification of 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, accessible via the following site: http://doi.org/10.1002/lsm.23524
About Apyx Medical Corporation:
Apyx Medical Corporation is a leading energy technology company with a passion for improving people’s lives through innovative products in the cosmetic and surgical markets. Known for its innovative helium plasma technology, Apyx is uniquely 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 surgery market. Renuvion® offers surgeons and physicians a unique ability to deliver controlled heat to tissue to achieve 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 unique waveform experience through original equipment manufacturing (OEM) agreements with other medical device manufacturers. For more information about the company and its products, please visit the Apyx Medical Corporation website at www.ApyxMedical.com.
Caution Regarding 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 federal securities laws. Although the Company believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, it cannot guarantee 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 could cause actual results to differ materially and could impact the company and the statements contained in this release may 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 the 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 undertakes no obligation to update or complete any forward-looking information. forward-looking statements, whether as a result of new information, future events or otherwise.