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enVVeno Medical Receives First-Ever FDA IDE Approval for a U.S. Pivotal Study of a Non-Surgical Replacement Venous Valve
First-in-Class enVVe system to be evaluated in TAVVE U.S. Pivotal TrialClinical site activation and patient enrollment expected to commence later this
About this update from Envveno Medical Corporation
[{"type":"text","content":"First-in-Class enVVe system to be evaluated in TAVVE U.S. Pivotal TrialClinical site activation and patient enrollment expected to commence later this yearLarge unmet clinical need for approximately 3 million U.S. patients with severe deep Chronic Venous InsufficiencyPotential multi-billion-dollar untapped U.S. marketCompany 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.\"We have been working very closely with the FDA to ensure that the TAVVE study is structured to provide everything that the FDA wants to see in evaluating the safety and efficacy of enVVe and that we are in complete alignment,\" said Robert Berman, enVVeno Medical's Chief Executive Officer. \"We have also been busy speaking with clinical sites that are interested in participating in the TAVVE study. A transcatheter-based non-surgical replacement venous valve has always been considered the \"holy-grail\" for patients with severe CVI and the interest and enthusiasm among physicians and their clinical teams has been extremely high. We are excited to be able to officially start the process of selecting and activating clinical sites and look forward to the first implantation procedure using the enVVe System.\"About the TAVVE StudyThe first stage of the TAVVE study, which is expected to commence later this year, will consist of 10 patients, whose 30-day safety results will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohor...