CLEARWATER, Florida–(BUSINESS WIRE)–Apyx Medical Corporation (NASDAQ:APYX) (the “Company”), a manufacturer of medical devices and supplies and the developer of Helium Plasma technology, marketed and sold as Renuvion® in the cosmetic surgery market and J-Plasma® in the hospital surgical market, today announced that it has submitted a 510(k) premarket notification (“510(k) submission”) to the United States Food and Drug Administration (“FDA”). The 510(k) submission seeks to expand its general indication to include a specific indication for the use of the Renuvion APR Handpiece in subcutaneous dermatological and aesthetic procedures to achieve thermal coagulation/contraction to improve the appearance of loose skin in the neck and submental region.
“We are delighted to announce the submission of this new 510(k) clearance request ahead of our previous expectations, which is intended to allow Apyx Medical to market and sell our Renuvion APR handpiece for use in improving the appearance of sagging (loose) skin in the neck and submental region,” said Charlie Goodwin, President and CEO. “This 510(k) submission represents a key milestone in our long-term strategy to pursue specific clinical indications related to our target procedures in the aesthetic or cosmetic surgery market The 510(k) is primarily based on safety and efficacy data from our U.S. IDE clinical study evaluating the use of Renuvion technology in the neck and submental area to improve the appearance of lax skin, and reflects a years-long effort by our clinical and regulatory teams. Apyx Medical colleagues, study investigators and study participants for helping to make this achievement possible.
Mr. Goodwin continued, “Receiving FDA clearance would allow us to expand the addressable market opportunity for our Renuvion technology by allowing us to market to surgeons and patients for this specific indication. With this goal in mind, we look forward to working with the FDA and providing them with all necessary support as they review our 510(k) submission.
About Apyx Medical Corporation:
Apyx Medical Corporation is a leading energy technology company with a passion for improving people’s lives through innovative products in the cosmetic and surgical markets. Known for its innovative helium plasma technology, Apyx is uniquely focused on bringing transformative solutions to physicians and their patients. Our helium plasma technology is marketed and sold as Renuvion® in the cosmetic surgery market and J-Plasma® in the hospital surgery market. Renuvion® offers plastic surgeons and aesthetic physicians a unique ability to deliver controlled heat to tissue to achieve desired results. We also leverage our deep expertise and decades of unique waveform experience through OEM agreements with other medical device manufacturers. For more information about the company and its products, please visit the Apyx Medical Corporation website at www.ApyxMedical.com.
Caution Regarding Forward-Looking Statements:
Certain matters discussed in this release and oral statements made from time to time by representatives of the Company may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and federal securities laws. Although the Company believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, it cannot guarantee that its expectations will be achieved.
All statements other than statements of historical facts are statements that could be considered forward-looking statements, including, but not limited to, any statement regarding the potential impact of the COVID-19 pandemic and the actions of governments, businesses and individuals in response to the situation; projections of net revenues, margins, expenses, net profits, net earnings per share or other financial items; projections or assumptions regarding the Company’s eventual receipt of any regulatory approvals from any governmental agency or instrument, including but not limited to the United States Food and Drug Administration, chain disruptions supply shortages, component shortages, manufacturing disruptions or logistical issues; or macroeconomic or geopolitical matters and the impact of such matters on the Company’s financial performance.
Forward-looking statements and information are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the Company’s ability to control or predict. Important factors that could cause the Company’s actual results to differ materially from and affect the Company and the statements contained in this release include, but are not limited to, risks, uncertainties and assumptions. related to the regulatory environment to which the Company is subject, including the Company’s ability to obtain the required approvals for its products from the United States Food and Drug Administration and other governmental and regulatory bodies, both at the national and international; the impact of recent FDA safety communications on our business and operations; factors relating to the effects of the COVID-19 pandemic; sudden or extreme volatility in commodity prices and availability, including supply chain disruptions; changes in general economic, business or demographic conditions or trends; changes and effects of the geopolitical environment; liabilities and costs the Company may incur as a result of pending or threatened litigation, claims, disputes or investigations; and other risks described in the company’s annual report on Form 10-K for the fiscal year ended December 31, 2021 and the company’s other filings with the Securities and Exchange Commission. For the forward-looking statements contained in this release, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The Company undertakes no obligation to update or supplement the forward-looking statements, whether as a result of new information, future events or otherwise.