- The FDA warned in a statement on Monday against the off-label use of Apyx Medical's Helium Plasma Technology in dermal resurfacing procedure. That triggered a 41% drop in the company's stock price. The shares regained about 2% in trading Tuesday morning.
- The device, sold as Renuvion and J-Plasma, uses radiofrequency energy and helium to generate plasma and is cleared for cutting, coagulation and ablation of soft tissue in surgical procedures. Apyx is awaiting 510(k) clearance in dermal resurfacing but the FDA has already received related adverse event reports.
- The agency issued the warning after receiving reports of second- and third-degree burns, infection and other adverse events, some of which required treatment in an intensive care unit, in patients who underwent aesthetic skin procedures. "The use of this device has not been determined to be safe or effective for any specific procedure intended to improve the appearance of the skin," the FDA said.
Dermal resurfacing is a long-standing target market for Apyx, which filed for clearance in the indication in 2018 only to withdraw the submission the following year. The company generated more data in the indication and recently refiled for 510(k) clearance. Throughout that time, the device was available in the U.S. for electrosurgical cutting, coagulation and ablation of soft tissue.
The FDA now has evidence physicians have used the device off-label. The reports to the agency describe "serious and potentially life-threatening adverse events after the device was used for aesthetic skin procedures." The list of adverse events submitted to FDA includes nerve damage and significant bleeding.
In response, the FDA has told healthcare providers the device is not cleared or approved for any aesthetic skin procedures and off-label use in that context may result in serious and potentially life-threatening adverse events.
"Do not use the Renuvion/J-Plasma device for dermal resurfacing or skin contraction, alone or in combination with liposuction," the agency warned healthcare providers. "If you are performing an aesthetic procedure, inform your patient which devices you plan to use."
The FDA also is advising consumers who are considering undergoing aesthetic skin procedures or liposuction to ask their providers whether they plan to use the Apyx device.
Apyx CEO Charlie Goodwin said in a statement that the company is aware that some of its products are used off-label for dermal resurfacing procedures but sought to distance the business from those practices.
"We do not and will not promote the use of our products – or train physicians – for these procedures until we receive clearance from the FDA. Our labeling specifically warns against the use of our products for this indication as well. We support the FDA's focus on ensuring that healthcare providers and patients understand the safe and proper use of our products," Goodwin said.
According to Goodwin, Apyx has submitted 90 medical device reports related to subdermal coagulation since the beginning of 2017. The company submitted 32 reports last year, up from 15 in 2020. Goodwin contends the increase factored into the FDA's decision to post the notice. The number of subdermal coagulation procedures performed with the Apyx products more than doubled from 2020 to 2021.
The CEO added that Apyx's two pending 510(k) premarket notifications remain under review by the FDA, which "are intended to obtain a general indication for use of the Renuvion Dermal handpiece in dermatological procedures requiring ablation and resurfacing of the skin, and a specific clinical indication for treating wrinkles and rhytids."