USFDAApr 29, 2026, 08:27 AM
NVNO Gets First-Ever FDA IDE Approval for Pivotal Venous Valve Study
AI Summary
enVVeno Medical Corp (NVNO) announced it received the first-ever FDA IDE approval to commence a U.S. pivotal study for its non-surgical replacement venous valve, the enVVe System. The Transcatheter Venous Valve Endoprosthesis (TAVVE®) study will evaluate the minimally invasive system for patients with severe deep Chronic Venous Insufficiency (CVI). The study will begin with 10 patients, followed by a larger cohort of 220 patients, and aims to address a large unmet clinical need for approximately 3 million U.S. patients. The company reported approximately $25 million in cash and investments as of March 31, 2026, expected to fund operations into Q3 2027.
Key Highlights
- enVVeno Medical received first-ever FDA IDE approval for a U.S. pivotal study of a non-surgical replacement venous valve.
- The TAVVE pivotal study will evaluate the enVVe System for severe deep Chronic Venous Insufficiency (CVI).
- The study's first stage will enroll 10 patients, with 30-day safety results submitted to the FDA.
- The second stage will enroll 220 patients (165 enVVe valve, 55 control) across up to 40 U.S. clinical sites.
- Approximately 3 million U.S. patients suffer from severe deep CVI, representing a potential multi-billion-dollar market.
- Company had approximately $25 million in cash and investments as of March 31, 2026.
- Cash and investments are expected to fund operations into Q3 2027.