enVVeno Medical is a pre-revenue medical device company developing a transcatheter (catheter-based, minimally invasive) replacement venous valve to treat severe Chronic Venous Insufficiency (CVI). CVI occurs when one-way valves inside leg veins fail, causing blood to pool in the lower leg and leading to debilitating swelling, pain, and venous leg ulcers. There are currently no approved surgical or non-surgical replacement venous valves anywhere in the world, leaving roughly 3.5 million severe deep venous CVI patients in the U.S. without an effective treatment. enVVeno's lead product is the enVVe System, a transcatheter valve designed to restore one-way blood flow up the leg. enVVeno previously developed a surgical venous valve (VenoValve), completed a pivotal clinical trial, and filed for FDA approval, but received a not-approvable letter in 2025. enVVeno has since abandoned VenoValve and pivoted entirely to enVVe, using clinical data and manufacturing experience from the VenoValve program to inform enVVe's design. enVVeno funds operations through capital raises and has no commercial revenue. Its path to revenue depends entirely on FDA pre-market approval (PMA) of the enVVe System. A pivotal clinical trial is expected to begin in 2026. If approved, enVVeno would sell the enVVe System to hospitals, targeting a broad physician base including vascular surgeons, interventional radiologists, and interventional cardiologists. enVVeno manufactures its tissue-based devices at its own facility in Irvine, California, and holds 42 patents globally.