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Apyx Medical Corporation Announces FDA 510(k) Submission with Clinical Study Support for the Use of the Renuvion® APR Handpiece for Aesthetic Procedures to Improve Appearance of Lax Skin
CLEARWATER, Fla.--(BUSINESS WIRE)-- Apyx Medical Corporation (NASDAQ:APYX) (the “Company”), a maker of medical devices and supplies and the developer of
About this update from Apyx Medical Corporation
[{"type":"text","content":" CLEARWATER, Fla.--(BUSINESS WIRE)--\nApyx Medical Corporation (NASDAQ:APYX) (the “Company”), a maker of medical devices and supplies 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 it has submitted a 510(k) premarket notification (“510(k) submission”) to the U.S. Food and Drug Administration (“FDA”). The 510(k) submission is intended to expand its general indication to include a specific indication for the use of the Renuvion APR Handpiece in subcutaneous dermatological and aesthetic procedures to achieve thermal coagulation/contraction to improve the appearance of lax (loose) skin in the neck and submental region.\n\n“We are excited to announce the submission of this new request for 510(k) clearance ahead of our prior expectations, which is intended to enable Apyx Medical to market and sell our Renuvion APR Handpiece for use to improve the appearance of lax (loose) skin in the neck and submental region,” said Charlie Goodwin, President and Chief Executive Officer. “This 510(k) submission represents a key milestone in our long-term strategy to pursue specific clinical indications related to our target procedures in the cosmetic or aesthetic surgery market. The 510(k) is primarily supported by safety and effectiveness data from our U.S. IDE clinical study evaluating the use of Renuvion technology in the neck and submental region to improve the appearance of lax (loose) skin, and reflects a multi-year effort from our clinical and regulatory teams. I would like to thank my Apyx Medical colleagues, study investigators and study participants for helping to make this achievement possible.”\n\nMr. Goodwin continued: “Receiving FDA clearance would allow us to expand the addressable market opportunity for our Renuvion technology by enabling us to market to surgeons and patients for this specific indication. With this goal in mind, we look forward to working with the FDA and providing them with any needed support as they review our 510(k) submission.”\n\nAbout Apyx Medical Corporation:\n\nApyx 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 our innovative Helium Plasma Technology, Apyx...