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.
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