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The clinical study is a multi-center, single arm, evaluator-blind prospective study evaluating the safety and efficacy of Bovie Medical’s J-Plasma technology for the reduction of facial wrinkles and rhytides. The study will be conducted at up to five investigational centers and will enroll 55 eligible subjects. Enrolled study subjects will receive one procedure with the Company’s J-Plasma technology at enrollment and wrinkle severity will be assessed using the Fitzpatrick Wrinkle and Elastosis Scale (FWS) at baseline and at each follow-up time point. The first patient was enrolled with Dr. J. David Holcomb at the Institute for Integrated Aesthetics in Sarasota, Florida.
“At Bovie Medical, our long-term clinical strategy is focused on expanding J-Plasma’s clinical indications for use in the aesthetics market, beginning with dermal skin resurfacing procedures,” said Charlie Goodwin, Chief Executive Officer. “Enrolling the first patient in our dermal skin resurfacing clinical study is an important milestone towards this long-term strategy. The Company intends to use data from this study to demonstrate the safety and efficacy of our J-Plasma technology to support our planned 510(k) submission to the U.S. Food and Drug Administration for an indication to market and sell J-Plasma for use in dermal resurfacing procedures.”
As of the publication of this release, additional details on the study may be found here.