Apyx Medical Corporation Announces Approval from FDA to Begin Phase II of U.S. IDE Study
Apyx Medical Corporation (NASDAQ:APYX) announced FDA approval to commence Phase II of its IDE clinical study for Renuvion® technology, aimed at skin laxity procedures in the neck and submental region. The approval includes updates to the treatment protocol, a revised statistical analysis plan, and an increase in investigational sites. Enrollment of 65 study subjects is expected to start in early December, with completion targeted for the third quarter of 2021. The company emphasizes its innovative Helium Plasma Technology in both cosmetic and surgical markets.
- FDA approval for Phase II clinical study of Renuvion® technology.
- Updated treatment protocol and statistical analysis plan enhance study design.
- Increase in number of investigational sites supports broader research.
- None.
CLEARWATER, Fla.--(BUSINESS WIRE)--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 received approval from the FDA to begin Phase II of its U.S. IDE clinical study evaluating the use of its Renuvion® technology in skin laxity procedures in the neck and submental region.
“We are pleased to announce that the FDA has approved our supplement and we can now move forward with Phase II of our IDE study evaluating the use of our Renuvion® technology for skin laxity procedures in the neck and submental region,” said Charlie Goodwin, President and Chief Executive Officer. “The approved supplement included changes to the treatment protocol based on feedback from study investigators during Phase I of the study, an updated statistical analysis plan and an increase in the number of investigational sites. We expect to begin enrollment of 65 study subjects in early December and plan to update the investment community upon completion of enrollment which we currently target occurring in the third quarter of 2021.”
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, 2019. 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.
