In a Phase II study, the Renuvion device improved the appearance of lax skin in 82.5% of subjects after 6 months.
Apyx Medical Corporation announced the results of the Phase II of its Investigational Device Exemption study evaluating the safety and effectiveness of the Renuvion device.
Renuvion is a proprietary helium plasma and radiofrequency technology designed to improve the appearance of lax skin in the neck and submental region.
In Phase II of the prospective, multi-center trial with 65 subjects, 82.5% of subjects demonstrated improvement in the appearance of lax skin in the neck and submental region at 6 months post-procedure. The results were 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.
Additional 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, according to Apyx.
“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.”
The Phase II study and its results are available online.
Image via Apyx Medical Corporation