The Renuvion APR Handpieces are now indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax skin in the neck and submental region.
The U.S. Food and Drug Administration received 510(k) clearance for the use of Apyx Medical’s Renuvion APR Handpiece for certain skin contraction procedures.
Specifically, the Renuvion APR Handpieces are now indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.
“Apyx Medical is proud to announce the receipt of this FDA 510(k) clearance, as now Renuvion is the only device that is FDA-cleared for improving the appearance of loose skin on the neck and chin,” says Charlie Goodwin, President and Chief Executive Officer, in a news release. “This represents a watershed moment for our Company on our journey to revolutionize the cosmetic surgery market by bringing transformative solutions to our customers. We can now market and sell Renuvion to surgeons and patients for use in the approximately 200,000 neck contouring procedures performed in the U.S. annually. Our clinical and regulatory teams have worked diligently over multiple years to make this achievement possible, and I would like to thank them for positioning us to achieve this clearance. As a reminder, our 510(k) submission for this indication was supported by safety and efficacy data from a U.S. IDE clinical study focused on the use of Renuvion in these procedures, and we announced the results of this study in a press release on July 8th.”
Mr. Goodwin continues: “We are excited to receive our first regulatory clearance for contouring procedures, and our second regulatory clearance for a specific clinical indication in less than two months, which further demonstrates our Company’s commitment to bringing evidence-based medicine to this industry. Building on this important achievement, we expect to commence a limited launch of Renuvion for this indication by the end of the third quarter of 2022, with the goal of entering full commercialization by the end of 2022. We are excited to make our Renuvion available to surgeons and patients seeking a new, clinically-proven treatment option to improve the appearance of lax, or loose, skin, and look forward to discussing this new clearance in further detail during our second quarter earnings call on August 11th.”
Apyx Medical Corporation products include Helium Plasma Technology products marketed and sold as Renuvion and J-Plasma in surgical markets. Renuvion and J-Plasma allow surgeons to provide controlled heat to tissue to achieve their desired results.
