$NVNO

enVVeno Medical (NASDAQ:NVNO) CEO Robert Berman presented at the Virtual Investor 'Why Now' conference, highlighting the company's enVVe treatment for severe Deep Venous Insufficiency and FDA IDE approval for a U.S. pivotal study. The TAVVE trial, starting in Q4 2026, aims to enroll 230 patients and is a key step toward potential regulatory approval. The webcast is available on-demand.

enVVeno Medical (NASDAQ:NVNO) said a peer-reviewed Journal of Vascular Surgery study found its venous valve replacement therapy could be cost-effective versus compression and wound care for severe deep venous reflux. The analysis projected over $32,000 savings per patient over five years, about 2.2 fewer ulcers, and cost-effectiveness by Year 2, citing potential $5.9B annual savings with broader adoption.

enVVeno Medical (NASDAQ:NVNO) reported Q2 2026 results and said the FDA granted IDE approval to start its TAVVE pivotal trial for its enVVe System. The company expects enrollment to begin in H2 2026 with about 230 patients across up to 40 sites. Cash and investments were about $21.5M at June 30, 2026, with Q2 net loss of $3.6M.

enVVeno Medical (NASDAQ:NVNO) said CEO Robert Berman discussed a newly issued first U.S. patent covering its enVVe system and an FDA IDE approval, ahead of a pivotal trial for a non-surgical replacement venous valve. The company frames the milestones as strengthening IP and competitive position in deep chronic venous insufficiency.

enVVeno Medical (NASDAQ:NVNO) said the U.S. Patent Office issued U.S. Patent No. 12,575,932 covering components and use methods of its enVVe transcatheter replacement venous valve system for deep venous insufficiency. The company links this to prior FDA IDE approval for its TAVVE pivotal trial, with enrollment to start and first patient data expected by end of Q4 2026.

enVVeno Medical (NVNO) has received FDA Investigational Device Exemption (IDE) approval for its pivotal TAVVE trial, which will evaluate the enVVe venous valve for severe deep Chronic Venous Insufficiency (CVI). This approval paves the way for a first-in-class non-surgical solution for approximately 3 million U.S. patients, a condition with limited viable therapies. The company also reported having $25 million in cash and investments, expected to fund operations until Q3 2027, allowing them to execute the trial and strengthen their market position.

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enVVeno Medical Corporation ( NASDAQ:NVNO ) ( "enVVeno" or the "Company" ) , a company setting new standards of care for the treatment of deep venous disease, announced the appointment of Jennifer Bright as Chief Financial Officer, effective today, May 19, 2025.