Apyx Medical Corp.—developer of Helium Plasma Technology, which is marketed and sold as Renuvion® and J-Plasma® in surgical markets—has received U.S. 510(k) clearance for the use of the Renuvion Dermal Handpiece for specific dermal-resurfacing procedures. The Renuvion Dermal Handpiece is indicated for dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II, or III.
“We are very pleased to receive FDA 510(k) clearance with a specific clinical indication that enables Apyx Medical to market and sell our Renuvion Cosmetic Technology to surgeons and patients for use in approximately 200,000 wrinkle-reduction procedures performed in the U.S. annually,” says Charlie Goodwin, the company’s president and CEO.
“This milestone represents one of the most important achievements of our organization since we began our multi-year strategy to position Apyx Medical for long-term success in the U.S. cosmetic surgery market, and I would like to thank our clinical and regulatory teams for making it possible,” he adds. “The receipt of regulatory clearance reflects the strong safety and efficacy profile of our Renuvion Cosmetic Technology, as demonstrated by the results of our U.S. IDE clinical study published in February.”
What’s more, Goodwin says, “This treatment for wrinkle reduction, branded as ‘Facial Renewal,’ represents an exciting new option for patients seeking to improve their appearance. We look forward to empowering surgeons and physicians to obtain the clinical results they, and their patients, are seeking by expanding the adoption and utilization of our Renuvion Cosmetic Technology for our new, specific clinical indication.”
The company plans to institute a limited launch of Renuvion for this indication in the third quarter of the year, with hopes of entering full commercialization by the end of 2022.