Therapy Areas: Devices
Apyx Medical Posts Results of the US IDE Clinical Study Evaluating the Use of Renuvion to Improve the Appearance of Lax Skin in the Neck and Submental Region
12 July 2022 - - US-based advanced energy technology company Apyx Medical Corp. (NASDAQ: APYX), the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion, has released results of the pivotal Phase II of its Investigational Device Exemption 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

In 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 six 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.

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.

Apyx Medical's Renuvion and J-Plasma offer surgeons a unique ability to provide controlled heat to tissue to achieve their desired results.