Apyx Medical Submits Additional FDA 510(k) For Expanded Use Of Renuvion In Dermatological Procedures

Apyx Medical Corporation APYX announced the publication of an article in a journal featuring the results of its U.S. IDE study evaluating the Renuvion Dermal Handpiece using Apyx's Helium Plasma Technology for dermal resurfacing procedures. 

• The Company has also submitted a 510(k) premarket notification to the FDA.
• The primary efficacy endpoint was achieved, with 100% of the study's subjects achieving a more than 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 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 was positive: 96.4% were "happy with results of procedure" and 83.6% "would recommend the procedure to a friend."
• No serious adverse events related to the study device or procedure occurred.
• Price Action: APYX shares are down 1.63% at $10.26 during the market session on the last check Thursday.