https://www.businesswire.com/news/home/20190401005837/en/

CLEARWATER, Fla.--(BUSINESS WIRE)--Apr 1, 2019--Apyx Medical Corporation, formerly known as Bovie Medical Corporation, (NASDAQ:APYX) (the “Company”), a maker of medical devices and supplies and the developer of J-Plasma ®, a patented surgical product marketed and sold under the Renuvion ® Cosmetic Technology brand in the cosmetic surgery market, today announced it has voluntarily withdrawn its application for premarket notification 510(k) regulatory clearance of J-Plasma/Renuvion for use in dermal resurfacing procedures. The Company will continue to work with the U.S. Food and Drug Administration (the “Agency”) relative to the development of a new 510(k) submission. At the present time, the Company cannot provide a timeline for resubmission but intends to do so after further discussions with the Agency.

As previously disclosed, on December 19, 2018, the Company filed a premarket notification 510(k) for regulatory clearance for a new clinical indication to market and sell Renuvion Cosmetic Technology for dermal resurfacing procedures. The application was supported by data from a multi-center, single arm, evaluator-blind prospective investigational device exemption (IDE) study evaluating the safety and efficacy of J-Plasma/Renuvion technology for the reduction of facial wrinkles and rhytides, which was conducted at three investigational centers and consisted of 55 patients. The primary efficacy endpoint was the comparison of the proportion of subjects (i.e., the percentage of treatment responders) with a ≥ 1-score improvement on the Fitzpatrick Wrinkle and Elastosis Scale (FWS) at the 3-month follow-up visit, as compared to baseline, as determined by at least 2 out of 3 blinded Independent Photographic Reviewers (IPRs). The primary safety endpoint was the adverse event rate and duration for a period of 3 months following the procedure.