Wrinkle Reduction Device Approved in the US

Wrinkle-Reduction Device Cleared by FDA in the United States Apyx Medical Corporation (NASDAQ: APYX), manufacturer of Renuvion®, a proprietary helium plasma and radiofrequency technology, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for the Renuvion Dermal handpiece for specific dermatological procedures directed at the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III. The wrinkle-reduction treatment, termed Facial Renewal, offers patients an effective and non-surgical option to smooth and tighten skin in a single procedure. Facial Renewal enables dermatologists, plastic surgeons and cosmetic physicians to achieve transformative results without patients requiring invasive surgery or risking an unnatural appearance. With Renuvion, Facial Renewal represents the first major advancement in facial skin treatments in decades and delivers dramatic and natural-looking results to patients. Tabasum Mir, oculoplastic surgeon in New York, said, "Renuvion is groundbreaking for facial procedures. It is a treatment that addresses a significant unmet need in cosmetic procedures." "I have been using Renuvion technology on patients in my practice and have witnessed its transformative results firsthand. With the new Facial Renewal clearance, this offers patients an entirely new treatment option to achieve the youthful appearance they are seeking." Charlie Goodwin, President and Chief Executive Officer, said, "We are very pleased to have received FDA clearance with a specific clinical indication that enables Apyx Medical to market and sell our Renuvion technology to physicians and patients for use in dermal surface renewal procedures." "Facial Renewal with Renuvion offers patients a refreshed and more youthful appearance without the unnatural 'pulled' look typically associated with a facelift." Source