Apyx Medical Corporation has received approval from the U.S. Food and Drug Administration (FDA) to begin Phase II of its U.S. IDE clinical study evaluating the use of its Renuvion helium plasma technology in skin laxity procedures in the neck and submental region.
“We are pleased to announce that the FDA has approved our supplement and we can now move forward with Phase II of our IDE study evaluating the use of our Renuvion technology for skin laxity procedures in the neck and submental region,” said Charlie Goodwin, president and CEO. “The approved supplement included changes to the treatment protocol based on feedback from study investigators during Phase I of the study, an updated statistical analysis plan and an increase in the number of investigational sites. We expect to begin enrollment of 65 study subjects in early December and plan to update the investment community upon completion of enrollment which we currently target occurring in the third quarter of 2021.”
Apyx makes medical devices and supplies, and develops Helium Plasma Technology, marketed and sold as Renuvion in the cosmetic surgery market and J-Plasma in the hospital surgical market.