Apyx Medical Corp, the manufacturer of Renuvion, a proprietary helium plasma and radiofrequency technology, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the use of Renuvion in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax skin in the neck and submental region. According to the company, the FDA clearance offers a new option for physicians and patients to improve loose skin on the neck and submental region.
Within the fat layer beneath the skin, there is a web-like structure of collagen fibers. These fibers provide support and elasticity to the skin itself. Age, weight fluctuations, and sun exposure contribute to the breakdown of these fibers, causing the skin to sag. Surface treatments often can’t deliver energy deep enough to effectively treat these fibers, and invasive surgery can be painful and is associated with having a long downtime. The Renuvion energy is used in a minimally-invasive procedure to directly treat the collagen fibers and address the root cause of neck and chin laxity.
“We are very pleased to receive FDA clearance enabling Apyx Medical’s Renuvion technology to be used in neck and chin laxity procedures,” said Charlie Goodwin, president and CEO. “We’ve seen a considerable uptick in the market for these cosmetic procedures and are thrilled to be able to offer our unique technology to physicians and their patients to meet this growing demand—it’s the next generation option for neck contouring procedures.”
The company recently released results of the Phase II of its Investigational Device Exemption study evaluating the safety and effectiveness of the Renuvion device. In Phase II of the prospective, multi-center trial with 65 subjects, 82.5% of subjects demonstrated improvement in the appearance of lax skin in the neck and submental region at 6 months post-procedure. The results were determined by 2 of 3 blinded Independent Photographic Reviewers.