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Apyx Medical Corporation Announces Subject Enrollment Initiated in Study Evaluating the Use of Renuvion® Technology in Skin Laxity Procedures in the Neck and Submental Region
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 an FDA approved U.S. Investigational Device Exemption (IDE) clinical study evaluating the use of its Renuvion technology in skin laxity procedures in the neck and submental region.\n\n\n“This clinical study is part of our strategy to expand the portfolio of clinical support for our Renuvion technology and pursue new clinical indications for cosmetic surgery procedures,” said Charlie Goodwin, Chief Executive Officer. “We expect to use data from the study to support our submission for a new regulatory clearance that would expand our addressable market opportunity for our Renuvion technology in the U.S. cosmetic surgery market.”\n\n\nThe study is a prospective, multi-center, multi-phase, evaluator-blinded study designed to evaluate the safety and effectiveness of Renuvion technology when used to improve the appearance of lax tissue in the neck and submental region. The study will be conducted at up to 5 investigational centers in the U.S. and consist of 52 subjects ranging from 35 to 65 years of age. The study will be conducted in two phases. Phase I will include 20 subjects, whose 1 month safety data will be reported to the FDA for a safety review. Following approval from the FDA, phase II of the study will be initiated, and will include 32 subjects. Effectiveness data will be collected for all 52 subjects in both phases of the study. Follow-up will occur 1 day, 1 week, 1 month, 3 months, and 6 months post procedure.\n\n\nThe study’s primary effectiveness endpoint will be improvement in the appearance of lax tissue in the neck and submental region at 6 months as determined by qualitative 2D photography assessment performed by three blinded Independent Photographic Reviewers. The study design assumes a 75% success rate of subjects with correctly identified images; therefore, greater than 75% of subjects must have their 6-month images correctly identified by 2 out of 3 blinded Independent Photographic Reviewers. The study’s primary and secondary ...