First-in-Class enVVe system to be evaluated in TAVVE U.S. Pivotal Trial

Clinical site activation and patient enrollment expected to commence later this year

Large unmet clinical need for approximately 3 million U.S. patients with severe deep Chronic Venous Insufficiency

Potential multi-billion-dollar untapped U.S. market

Company has approximately $25 million in cash and investments to fund operations into Q3 2027

IRVINE, CA / ACCESS Newswire / April 29, 2026 / 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 the U.S. Food and Drug Administration (FDA) has awarded the Company the first-ever IDE approval to proceed with a U.S. pivotal study of a non-surgical replacement venous valve. The Transcatheter Venous Valve Endoprosthesis (TAVVE®) pivotal study will evaluate the Company's minimally invasive enVVe® System for patients with severe deep Chronic Venous Insufficiency (CVI).

This IDE approval positions the Company to advance what could become the first effective treatment option for the approximately 3 million U.S. patients who suffer from the debilitating impact of severe CVI due to malfunctioning valves in the deep veins of the leg.