enVVeno Medical Corp. has announced plans to file a request for supervisory appeal following a not-approvable letter from the Center for Devices and Radiological Health (CDRH) of the U.S. Food & Drug Administration (FDA) regarding its Premarket Approval (PMA) application for the VenoValve®. The device is a surgical replacement venous valve aimed at treating severe deep chronic venous insufficiency $(CVI)$. enVVeno Medical, which has an established working relationship with the FDA through its previous interactions for Breakthrough Device Designation and Investigational Device Exemption, views this appeal as an opportunity to address issues collaboratively. The company is optimistic that presenting their data in a supervisory appeal will lead to a favorable decision by the end of 2025.