EnVVeno Medical Engages in Virtual Investor Segment Amid FDA Appeal

enVVeno Medical Corporation (NASDAQ:NVNO), based in Irvine, announced its participation in a Virtual Investor "What This Means" segment. The segment included insights from CEO Robert Berman on the company's recent appeal following an FDA decision regarding their VenoValve® product. The FDA's Center for Devices and Radiological Health previously issued a not-approvable letter in response to enVVeno's Premarket Approval application for this surgical venous valve.

The VenoValve® is designed to treat severe chronic venous insufficiency by replacing damaged venous valves. enVVeno is also developing enVVe®, a non-surgical alternative currently undergoing final tests before a pivotal trial in the U.S. Both devices aim to improve blood flow from the legs back to the heart.