enVVeno Medical Corp

enVVeno Medical Corporation is a medical device company that develops innovative tissue-based solutions to treat venous disease. Chronic Venous Disease (CVD) affects approximately 70% of the adult population of the U.S. A significant part of CVD is Chronic Venous Insufficiency (CVI), which happens when leg vein valves are damaged, causing blood to flow backward, pool in the lower leg, and increase pressure, sometimes leading to hard-to-heal venous ulcers. The company is creating a replacement venous valve for patients with severe CVI in the deep venous system of the leg. Initially, the company developed the VenoValve®, a surgical replacement venous valve, but received a not-approvable letter from the FDA for its PMA application in August 2025. The company is now concentrating on its next-generation, non-surgical venous valve product, the enVVe® System. This system includes the enVVe Valve, enVVe Delivery System, enVVe Nose Cone, enVVe Delivery System Accessories, and enVVe Crimping System. The enVVe Valve is a non-surgical, transcatheter-based replacement venous valve designed to act as a one-way valve to help blood flow up the leg veins back to the heart and lungs. The company has finished pre-clinical testing on the enVVe System and has started discussions with the U.S. Food and Drug Administration (FDA) regarding the enVVe pivotal trial.