Apyx Medical Corporation Announces FDA 510(k) Submission for the Use of Renuvion® in Dermal Resurfacing Procedures
Apyx Medical Corporation (NASDAQ:APYX) has submitted a 510(k) premarket notification to the FDA seeking a specific clinical indication for its Renuvion device in dermal resurfacing procedures. This submission follows the recent completion of a U.S. IDE clinical study and signifies a crucial milestone for the company in expanding its market potential. CEO Charlie Goodwin noted the team's efforts in achieving this progress and expressed optimism regarding the FDA's review process.
- Submission of 510(k) is a key milestone for Renuvion's market expansion.
- Completion of U.S. IDE clinical study supports regulatory submission.
- None.
Apyx Medical Corporation (NASDAQ:APYX) (the “Company”), a maker 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 it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (“FDA”), which is intended to obtain a specific clinical indication for the use of Renuvion in dermal resurfacing procedures.
“Following the recent completion of our U.S. IDE clinical study evaluating the use of our Renuvion technology in dermal resurfacing procedures, we were pleased to submit our 510(k) premarket notification for this procedure category on May 28th,” said Charlie Goodwin, President and Chief Executive Officer. “This submission is an important milestone that underscores our continued progress in pursuing specific clinical indications to market and sell Renuvion for target procedures in the cosmetic surgery market. I would like to thank our clinical and regulatory teams for their exceptional efforts which has made our recent progress possible, and look forward to the FDA’s review of our submission.”
About Apyx Medical Corporation:
Apyx Medical Corporation is an advanced energy technology company with a passion for elevating people’s lives through innovative products in the cosmetic and surgical markets. Known for its innovative Helium Plasma Technology, Apyx is solely focused on bringing transformative solutions to the physicians and patients it serves. The company’s Helium Plasma Technology is marketed and sold as Renuvion® in the cosmetic surgery market and J-Plasma® in the hospital surgical market. Renuvion® offers surgeons and physicians a unique ability to provide controlled heat to the tissue to achieve their desired results. The J-Plasma® system allows surgeons to operate with a high level of precision while minimizing unintended tissue trauma. The Company also leverages its deep expertise and decades of experience in unique waveforms through original equipment manufacturing (OEM) agreements with other medical device manufacturers. For further information about the Company and its products, please refer to the Apyx Medical Corporation website at www.ApyxMedical.com.
Cautionary Statement on 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 the Federal securities laws. Although the Company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that its expectations will be achieved.
Forward-looking information is 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 may cause actual results to differ materially and that could impact the Company and the statements contained in this release can be found in the Company’s filings with the Securities and Exchange Commission including the Company’s Report on Form 10-K for the year ended December 31, 2020. For forward-looking statements 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 assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.
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