enVVeno Medical wins FDA IDE approval for U.S. pivotal trial of enVVe venous valve

• FDA granted enVVeno first-ever investigational device exemption to launch a U.S. pivotal study of its enVVe transcatheter replacement venous valve for severe deep chronic venous insufficiency.
• TAVVE trial plans initial 10-patient safety cohort, followed by 220 patients randomized 165 to enVVe versus 55 to standard of care.
• enVVeno expects site activation and patient enrollment to begin later this year.
• Company reported about $25 million in cash and investments as of March 31, 2026, projected to fund operations into Q3 2027.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. enVVeno Medical Corp. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 202604290805ACCESSWRNAPR_____1162261) on April 29, 2026, and is solely responsible for the information contained therein.