enVVeno Medical Corp 8K

enVVeno Medical Corporation received first-ever FDA IDE approval for a U.S. pivotal trial of its enVVe non-surgical replacement venous valve and outlined trial design and funding runway into Q3 2027.

On April 29, 2026, enVVeno Medical Corporation announced that the U.S. Food and Drug Administration granted the company the first-ever Investigational Device Exemption (IDE) approval for a U.S. pivotal study of a non-surgical replacement venous valve, enabling initiation of the Transcatheter Venous Valve Endoprosthesis (TAVVE) pivotal trial to evaluate its minimally invasive enVVe system in patients with severe deep chronic venous insufficiency; the two-stage study will begin later in 2026 with an initial 10-patient safety cohort followed by a 220-patient randomized phase across up to 40 U.S. sites, and the company disclosed that it had approximately $25 million in cash and investments as of March 31, 2026, expected to fund operations into the third quarter of 2027 and potentially support filing for FDA post-marketing approval one year after enrollment of the 220th patient.

Filing Facts

CIK

1661053

Ticker

-

Form

8K

Source Type

sec

Accession

0001493152-26-019485

Alert Tier

6