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Interim two-year follow-up data from 42 subjects in the VenoValve pivotal trial show sustained clinical improvement and continued patient benefit at 24 months compared to baseline
83% of subjects maintained a clinically meaningful benefit with a 3 or more point improvement in Revised Venous Clinical Severity Score (rVCSS)
9.1 point average rVCSS improvement among the clinically meaningful benefit cohort
Subjects experienced a median 74% improvement in leg pain
Interim follow-up data indicate sustained improvements across all venous-specific quality-of-life (QoL) indicators
A decision from the U.S. Food and Drug Administration (FDA) on the VenoValve is anticipated in the second half of 2025
Company to host live webcast with presenting Principal Investigator, today, June 6th at 11:20 AM ET / 10:20 AM CT - Access the Webcast Here
IRVINE, CA / ACCESS Newswire / June 6, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that interim two-year follow-up data on 42 subjects from the 75 person VenoValve U.S. pivotal trial will be presented today by lead enroller Dr. Cassius Iyad Ochoa Chaar, at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting (VAM25) being held June 4-7, 2025 in New Orleans, LA. Additionally, the Company announced it will host a live webcast to discuss these interim results today, Friday, June 6th at 11:20 AM ET / 10:20 AM CT (details below).
Key interim two-year follow-up data being presented at VAM25 include:
83.3% of subjects (n=35/42) maintained a clinically meaningful benefit, defined as an improvement of 3 or more points in the revised Venous Clinical Severity Score (rVCSS).
9.1 point average rVCSS improvement among the responder cohort.
A median 74% improvement in leg pain, as measured by the Visual Analog Scale (VAS).
Wound healing outcomes in 17 subjects with 25 ulcers showed that 60% of ulcers healed completely, 24% decreased in size, and 16% increased in size.
Patient-reported outcomes also demonstrated sustained improvements across all venous specific QoL indicators (VEINES-QoL/Sym).
Among the subjects (n=30), a 100% valve patency rate.
All values were calculated comparing each patient's baseline levels to the reported values at the patient's 24-month visit. The Revised Venous Clinical Severity Score (rVCSS) is a clinically validated scoring system used to track the progression or regression of venous diseases.
Posted In: NVNO
