Business
Apyx Medical Corporation Announces Peer-Reviewed Publication Featuring Results from the U.S. IDE Clinical Study Evaluating the Renuvion® Dermal Handpiece Using Apyx’s Helium Plasma Technology for Dermal Resurfacing Procedures
Announces Additional FDA 510(k) Submission for the Use of the Renuvion® Dermal Handpiece in Dermatological Procedures Requiring Ablation and Resurfacing of
About this update from Apyx Medical Corporation
[{"type":"text","content":"\nAnnounces Additional FDA 510(k) Submission for the Use of the Renuvion® Dermal Handpiece in Dermatological Procedures Requiring Ablation and Resurfacing of the Skin\n\n CLEARWATER, Fla.--(BUSINESS WIRE)--\nApyx 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.\n\nSummary of results of the U.S. IDE Clinical Study Evaluating Helium Plasma Technology for Dermal Resurfacing Procedures:\n\n\nThe 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.\n\n\nThe 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.\n\n\n96.4% 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.\n\n\n\n\nAll 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.\n\n\nSubjects’ 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.”\n\n\nNo serious adverse events related to the study device or procedure occurred.\n\n\n269 adverse events and expected treatment effects were reported: 99.3% were of “Mild” o...