Advanced energy tech company Apyx Medical Corp. (APYX:NASDAQ), a medical device and supply manufacturer and developer of Helium Plasma Technology that allows surgeons to provide controlled heat to tissue to achieve their desired results, yesterday announced, "it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the use of the Renuvion Dermal Handpiece for specific dermal resurfacing procedures."
Apyx Medical markets and sells its innovative medical devices and instruments for use in surgical markets under the Renuvion® and J-Plasma® names. The company advised that "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."
The company's President and CEO Charlie Goodwin commented, "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…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."
"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," Goodwin added.
The company indicated in the news release that its Renuvion Cosmetic Technology will be branded as "Facial Renewal" and will provide patients with new specific clinical options to improve their appearance and reduce wrinkles.
The firm stated that it intends to roll out Renuvion for treatment of this newly approved indication on a limited basis starting in Q3/22 and plans to move forward with a full commercial launch by calendar year-end 2022.
Apyx Medical is an advanced energy tech firm based in Clearwater, Fl. The company operates through two primary business segments. Its advanced energy line includes the firm's innovative Helium Plasma Technology products that are marketed and sold for use in surgical markets under the Renuvion® and J-Plasma® names.
Renuvion® and J-Plasma® offer surgeons a unique ability to provide controlled heat to tissue to achieve their desired results. The company claims on its website that Renuvion®, which is engineered to deliver a proprietary balance of helium and RF energy, is ideal for use in medical procedures where precision and control are critical factors in delivering effective treatment. The firm adds that "J-Plasma® is an advanced energy modality which combines the unique properties of helium plasma with a proprietary RF waveform."
The company additionally serves as an original equipment manufacturer (OEM) for other medical device makers that rely on Apyx's depth of experience in technology employing unique directed waveforms.
Apyx Medical started off yesterday with a market cap of around $127.5 million with approximately 34.45 million shares outstanding and a short interest of about 3.4%. APYX shares opened 8% higher yesterday at $4.00 (+$0.30, +8.11%) over Wednesday's $3.70 closing price. The stock traded yesterday between $4.00 and $5.77 per share and was trading at $5.58 (+$1.88, +50.81%) yesterday.
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