enVVeno Medical announces publication of VenoValve first-in-human trial data

enVVeno Medical (NVNO) announced that its manuscript titled, “Three-Year Outcomes of Surgical Implantation of a Novel Bioprosthetic Valve for the Treatment of Deep Venous Reflux1,” has been published in the in the peer-reviewed journal, Annals of Vascular Surgery. The VenoValve was surgically implanted in the femoral vein of eleven subjects with active or healed venous ulcers. Eight subjects completed three years of follow-up, with key findings including: Primary patency: 79% at three years; Symptom relief: 7 point improvement Venous Clinical Severity Score; 84% reduction in pain on the Visual Analog Scale; The VenoValve remained safe and effective, achieving target patency and maintaining competence and clinical benefits. The VenoValve is a potential first-in-class, surgical replacement venous valve for patients with severe deep venous CVI. The Company estimates that there are approximately 2.5 million potential new patients each year in the U.S. that could be candidates for the VenoValve. The Company has submitted a pre-market authorization application for the VenoValve to the U.S. Food and Drug Administration, with a decision anticipated in the second half of 2025.