The Company also announced that the FDA has concluded that the requirements were met for its Safety Report for the Feasibility Study (Phase I) of its U.S. IDE clinical study evaluating the use of its Renuvion® technology in skin laxity procedures in the neck and submental region

FDA device

The US FDA’s Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)

Apyx Medical, a maker of medical devices and supplies and the developer of Helium Plasma Technology, marketed and sold as Renuvion in the cosmetic surgery market and J-Plasma in the hospital surgical market, today announced that it has completed subject enrollment in a U.S. Investigational Device Exemption (IDE) clinical study evaluating the use of its Renuvion® Technology in dermal resurfacing procedures.

The Company also announced that the FDA has concluded that the requirements were met for its Safety Report for the Feasibility Study (Phase I) of its U.S. IDE clinical study evaluating the use of its Renuvion® technology in skin laxity procedures in the neck and submental region.

“We are very pleased to announce the achievement of two key milestones in our strategy to pursue specific clinical indications that will enable us to market and sell Renuvion® for target procedures in the cosmetic surgery market,” said Charlie Goodwin, President and Chief Executive Officer. “Specifically, last week, we completed enrollment in our U.S. IDE clinical study evaluating the use of Renuvion® technology for dermal resurfacing procedures.

“We have also made significant progress in our other IDE study evaluating the use of our Renuvion® technology for skin laxity procedures in the neck and submental region. We completed enrollment and submitted our Safety Report for Feasibility Study (Phase I) and we are happy to announce that last week, FDA concluded that we met the requirements for Phase I completion. We look forward to working with the FDA to begin Phase II.”

Apyx Medical Corporation is an advanced energy technology company with a passion for elevating people’s lives through innovative products in the cosmetic and surgical markets. Known for its innovative Helium Plasma Technology, Apyx is solely focused on bringing transformative solutions to the physicians and patients it serves.

Source: Company Press Release