Three-Year VenoValve(R) First-in-Human Trial Data Published in the Annals of Vascular Surgery

Promising results from the first-in-human study demonstrated that, at three-years post implantation, VenoValve remained safe and effective--achieving a high rate of patency, restoring deep venous competence and maintaining clinical benefits

Company has submitted PMA application for the VenoValve to the U.S. Food and Drug Administration (FDA) with a decision anticipated in the second half of 2025

IRVINE, CA / ACCESS Newswire / May 13, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today 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 (CEAP classifications C5-C6). Eight subjects completed three years of follow-up, with key findings including:

• Primary patency: 79% (Kaplan-Meier curve) at three years

• Symptom relief: 7 point improvement Venous Clinical Severity Score; 84% reduction in pain on the Visual Analog Scale (VAS)

• 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 (PMA) application for the VenoValve to the U.S. Food and Drug Administration (FDA), with a decision anticipated in the second half of 2025.

About CVI

Severe, deep venous Chronic Venous Insufficiency (CVI) is a debilitating disease that is most often caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. When valves inside of the veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase (venous hypertension). Symptoms of severe CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as sleeping, bathing, dressing, and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence. Estimates indicate that CVI costs the U.S. healthcare system in excess of $4 billion each year.