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Apyx Medical Corporation Announces Results of the U.S. IDE Clinical Study Evaluating the Use of Renuvion to Improve the Appearance of Lax Skin in the Neck and Submental Region
CLEARWATER, Fla.--(BUSINESS WIRE)-- Apyx Medical Corporation (NASDAQ:APYX) (the “Company”), the manufacturer of a proprietary helium plasma and
About this update from Apyx Medical Corporation
[{"type":"text","content":" CLEARWATER, Fla.--(BUSINESS WIRE)--\nApyx Medical Corporation (NASDAQ:APYX) (the “Company”), the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, today announced that the results of the pivotal Phase II of its Investigational Device Exemption (“IDE”) study evaluating the safety and effectiveness of the Renuvion device to improve the appearance of lax skin in the neck and submental region have been posted on ClinicalTrials.gov. The results can be found here: https://www.clinicaltrials.gov/ct2/show/results/NCT04146467?term=apyx+medical&draw=2&rank=6\n\nIn Phase II of this prospective, multi-center trial with 65 subjects, the primary effectiveness endpoint of the study was met, with 82.5% of subjects demonstrating improvement in the appearance of lax skin in the neck and submental region at 6 months post-procedure, as determined by 2 of 3 blinded Independent Photographic Reviewers. The primary safety endpoint of the study was also met, with 96.9% of subjects experiencing no pain to moderate pain through the first seven days following the procedure.\n\nAdditional effectiveness endpoints in the study also demonstrated success, with 85.5% of subjects rating themselves as improved and 87.1% of subjects rated improved by the study investigators at the 6-month follow-up visit. There were no serious adverse events reported in the study that were related to the Renuvion device or the study procedure.\n\n“We are pleased to share the impressive results achieved in this U.S. IDE clinical study evaluating the use of Renuvion to improve the appearance of lax skin in the neck and submental region,” said Charlie Goodwin, President and Chief Executive Officer. “The totality of the data in this study demonstrated both the safety and effectiveness of Renuvion for these contouring procedures. We are excited by these findings, and look forward to marketing Renuvion to surgeons and their patients pending the receipt of clearance on our FDA 510(k) submission for a specific clinical indication to address these procedures.”\n\nAbout Apyx Medical Corporation:\n\nApyx Medical Corporation is an advanced energy technology company with a passion for elevating people’s lives through innovative products, including its Helium Plasma Technology products marketed and sold as Renuvion® in the cosmetic surgery...