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Apyx Medical Corporation Announces Subject Enrollment Initiated in New Study Evaluating the Use of Renuvion® Technology in Dermal Resurfacing Procedures
CLEARWATER, Fla.--(BUSINESS WIRE)-- Apyx Medical Corporation, formerly Bovie Medical Corporation, (NASDAQ:APYX) (the “Company”), a maker of medical devices
About this update from Apyx Medical Corporation
[{"type":"text","content":" CLEARWATER, Fla.--(BUSINESS WIRE)--\nApyx Medical Corporation, formerly Bovie Medical Corporation, (NASDAQ:APYX) (the “Company”), a maker of medical devices and supplies and the developer of its Helium Plasma Technology, marketed and sold as Renuvion® in the cosmetic surgery market and as J-Plasma® in the hospital surgical market, announced today that it has initiated subject enrollment in a U.S. Investigational Device Exemption (IDE) clinical study evaluating the use of its Renuvion technology in dermal resurfacing procedures.\n\n\n“The initiation of subject enrollment in this clinical study marks the continued advancement of our regulatory strategy to expand our addressable market opportunity in the U.S. cosmetic surgery market by pursuing new clinical indications for target procedures,” said Charlie Goodwin, Chief Executive Officer. “We expect the data from this study to support our submission for a new regulatory clearance that would enable us to market our Renuvion technology for dermal resurfacing procedures.”\n\n\nThe study is a prospective, multi-center, single arm, evaluator-blinded clinical study designed to demonstrate the safety and effectiveness of Renuvion technology for use in dermal resurfacing procedures. The study will be conducted at up to 5 investigation centers in the U.S. and consist of up to 55 subjects who are at least 30 years of age and seeking a procedure to improve facial appearance by reducing wrinkles and rhytides. Follow-up will occur immediately following the procedure, at 1 day, 6 days, 10 days, 30 days, 90 days and 180 days.\n\n\nThe study’s primary effectiveness endpoint is the proportion of subjects with at least a one-point improvement from baseline in the Fitzpatrick Wrinkle and Elastosis Scale at 90 days, as determined in a randomized order by at least 2 out of 3 blinded Independent Photographic Reviewers (IPR). The primary effectiveness endpoint will have been met if the proportion of subjects achieving at least a one-point improvement, as determined by 2 out of 3 IPRs, is at least 70%. The study’s primary and secondary safety endpoints will be the evaluation of adverse events and the evaluation of the change in pain and discomfort after treatment. The study also includes additional endpoints which will be listed in an overview of the study on clinicaltrials.gov.\n\n\nAn overview of the s...