Apyx Medical Corporation (NASDAQ: APYX) is engaged as a medical device and supplies company, which operates two key innovative products through its Helium Plasma Technology platform: Renuvion and J-Plasma. Both products give surgeons the ability to provide controlled heat to tissue applications. Shares of the medical device company are jumping 41% through early trading on Thursday, May 26, 2022. Over the past three months, Apyx Medical has seen average daily volume of 156,990 shares. However, volume of 11.59 million shares or dollar volume of around $58.76 million, has already exchanged hands through early trading.
Shares of Apyx Medical are rallying after the company announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to use its Renuvion Dermal Handpiece during specific dermal resurfacing procedures. The innovative product is designed to treat dermatological procedures, such as the treatment of moderate-to-severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III.
Apyx Medical President and CEO, Charlie Goodwin, says the Renuvion-based wrinkle reduction treatment will be branded as “Facial Renewal,” and will begin a limited launch during the third quarter of 2022. The company estimates full commercialization by the end of 2022.
“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,” said Charlie Goodwin, President and Chief Executive Officer. “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. 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.”
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