enVVeno receives FDA IDE approval for pivotal study of non-surgical venous valve; $25M cash

enVVeno Medical Corp

FDA grants first-ever IDE for a U.S. pivotal study of a non-surgical replacement venous valve (enVVe System).
TAVVE study: stage 1 enrolls 10 patients; stage 2 enrolls 220 patients (165 valve, 55 control) at up to 40 US sites.
Company reports ~$25M cash/investments as of March 31, 2026, funding operations into Q3 2027.
Addresses ~3 million U.S. patients with severe deep CVI; no effective current treatments for valvular incompetence.
enVVe features: 13Fr delivery profile, porcine pericardium leaflet, no general anesthesia needed.

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