NVNO · enVVeno Medical Corporation

enVVeno Medical Corporation announced FDA approval of its Investigational Device Exemption (IDE) application on April 29, 2026, authorizing the pivotal TAVVE study for the enVVe system, a minimally invasive transcatheter venous valve for patients with severe deep Chronic Venous Insufficiency (CVI). This first-ever IDE for a non-surgical replacement venous valve represents a critical clinical milestone, enabling commencement of the study later in 2026. The study is structured in two stages: an initial safety cohort of 10 patients with 30-day results submitted to the FDA, followed by a randomized pivotal stage enrolling 220 patients across up to 40 U.S. sites involving vascular surgeons, interventional radiologists, and cardiologists. Treatment patients (165) will receive the enVVe valve, compared against 55 control patients on standard care. Eligibility for FDA post-marketing approval arises one year post-enrollment of the 220th patient, potentially accelerating path to commercialization for a device addressing an unmet need in approximately 3 million U.S. CVI patients. Key enVVe features include a 13 Fr delivery profile, self-expanding nitinol frame, and mono-cusp porcine pericardium leaflet, designed for outpatient procedures without general anesthesia. Concurrently, the company disclosed $25 million in cash and investments as of March 31, 2026, incorporated under Item 2.02, sufficient to fund operations into Q3 2027, providing runway through early study execution. This dual disclosure via press release (Exhibit 99.1) under Regulation FD enhances transparency for investors on both product advancement and financial stability.