The clinical trial will demonstrate the safety and effectiveness of Renuvion technology for use in dermal resurfacing procedures
Image: The study will demonstrate the safety and effectiveness of Renuvion technology for use in dermal resurfacing procedures. Photo: courtesy of Free-Photos from Pixabay.
Apyx Medical has commenced the enrollment of patients in a new study designed to assess the use of its Renuvion technology in dermal resurfacing procedures.
Apyx Medical, formerly Bovie Medical, provides Helium Plasma Technology as Renuvion in the cosmetic surgery market and as J-Plasma in the hospital surgical market.
Renuvion allows plastic surgeons, fascial plastic surgeons and cosmetic physicians to deliver controlled heat to the tissue to achieve the required results. The J-Plasma system enables surgeons to operate with a high level of precision.
The US investigational device exemption (IDE) study is a prospective, multi-centre, single-arm and evaluator-blinded clinical trial, which will show the safety and effectiveness of Renuvion technology for use in dermal resurfacing procedures.
The study will enroll patients seeking a procedure to improve facial appearance by reducing wrinkles and rhytides
Apyx will carry out the trial at up to five investigation centres in the US. It will recruit around 55 patients who are at least 30 years of age and seeking a procedure to enhance facial appearance by minimising wrinkles and rhytides.
The company will immediately follow the patients after a procedure on first day, 6 days, 10 days, 30 days, 90 days and 180 days.
According to the company, the trial’s primary effectiveness endpoint is the proportion of subjects with at least a one-point improvement from baseline in the Fitzpatrick Wrinkle and Elastosis Scale at 90 days, as determined in a randomized order by at least 2 out of 3 blinded Independent Photographic Reviewers (IPR).
Apyx Medical CEO Charlie Goodwin said: “The initiation of subject enrollment in this clinical study marks the continued advancement of our regulatory strategy to expand our addressable market opportunity in the U.S. cosmetic surgery market by pursuing new clinical indications for target procedures.
“We expect the data from this study to support our submission for a new regulatory clearance that would enable us to market our Renuvion technology for dermal resurfacing procedures.”
In October this year, Apyx Medical announced that the US Food and Drug Administration (FDA) has granted 510(k) approval for the Apyx Plasma/RF Handpiece, a new product in the Renuvion family.