enVVeno Medical Corporation (NASDAQ: NVNO) saw its stock price surge by 17.83%, reaching $4.10 at last check, after unveiling compelling interim data from its pivotal VenoValve clinical trial. The findings are being formally reported at the Society for Vascular Surgery’s 2025 Vascular Annual Meeting (VAM25) taking place in New Orleans, Louisiana, from June 4–7.
VenoValve Trial Shows Substantial Progress
The interim analysis covers a two-year follow-up of 42 participants from a total cohort of 75 enrolled in the U.S. pivotal trial for the VenoValve device. Dr. Cassius Iyad Ochoa Chaar, the study’s lead enroller, is scheduled to present the findings.
Statistics showed that 83.3% of participants saw a clinically significant improvement, which is shown by an improvement of at least three points on the revised Venous Clinical Severity Score (rVCSS). Responders demonstrated an average rVCSS improvement of 9.1 points and reported a 74% median reduction in leg pain, as measured by the Visual Analog Scale (VAS).
Improved Wound Healing and Quality of Life Outcomes
Among 17 patients with a total of 25 venous ulcers, 60% of the ulcers healed completely, 24% showed a reduction in size, and 16% worsened. All venous-specific quality of life measurements, including VEINES-QoL/Sym markers, showed consistent improvements, according to patient-reported outcomes. Notably, the study recorded a 100% valve patency rate across the cohort, measured at each patient’s 24-month follow-up relative to baseline data.
Potential Paradigm Shift in CVI Treatment
The VenoValve is designed as a first-in-class, surgically implanted venous valve targeting patients with severe deep venous chronic venous insufficiency (CVI)—a condition historically lacking effective long-term treatments. enVVeno emphasized that all participants in the study had previously exhausted other therapeutic options.
With an estimated 2.5 million potential new U.S. candidates annually, the company sees significant market opportunity. The U.S. Food and Drug Administration has received enVVeno’s (NVNO) pre-market approval (PMA) application; a decision is anticipated in the second half of 2025.
