enVVeno Medical

enVVeno Medical, based in Irvine, California, is a late clinical stage medical device company dedicated to advancing bioprosthetic tissue-based solutions to elevate the standard of care for venous disease treatment. The company primarily targets patients suffering from Chronic Venous Insufficiency (CVI), a condition where damaged valves in the leg veins hinder blood return to the heart and lungs. enVVeno's flagship product, the VenoValve, is a pioneering surgical replacement venous valve designed for deep venous CVI treatment. Additionally, the company is developing enVVe, a non-surgical, transcatheter-based replacement venous valve, also aimed at treating deep venous CVI. Both devices function as one-way valves to facilitate blood flow from the legs back to the heart and lungs. Currently, these devices are investigational and are being evaluated in clinical studies, such as the SAVVE U.S. pivotal study for the VenoValve and awaiting regulatory approval for the TAVVE first-in-human trial for enVVe. enVVeno's business model focuses on innovation in medical devices, with revenue generation anticipated through future product sales post regulatory approvals. The company operates within the medical device market, serving healthcare providers and patients with venous disease. Keywords: bioprosthetic, venous disease, Chronic Venous Insufficiency, VenoValve, enVVe, surgical valve, transcatheter valve, clinical stage, medical device, regulatory approval.