enVVeno Medical announces two-year data from VenoValve pivotal study

enVVeno Medical (NVNO) announced that interim two-year follow-up data on 42 subjects from the 75 person VenoValve U.S. pivotal trial will be presented by lead enroller Dr. Cassius Iyad Ochoa Chaar, at the Society for Vascular Surgery 2025 Vascular Annual Meeting 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, Friday, June 6th at 11:20 AM ET / 10:20 AM CT. Key interim two-year follow-up data being presented at VAM25 include: 83.3% of subjects maintained a clinically meaningful benefit, defined as an improvement of 3 or more points in the revised Venous Clinical Severity Score. 9.1 point average rVCSS improvement among the responder cohort. A median 74% improvement in leg pain, as measured by the Visual Analog Scale. 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. Among the subjects, 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 is a clinically validated scoring system used to track the progression or regression of venous diseases. “These interim two-year follow-up data demonstrate substantial and sustained improvement across all effectiveness endpoints at two years. This is extremely encouraging, especially when you consider that all the patients enrolled in the study had severe CVI and failed all other treatment options,” said Robert Berman, CEO. “Despite attempts over many decades, nobody has been able to create an effective treatment for severe CVI caused by malfunctioning valves in the deep veins of the leg. The VenoValve has the potential to change the treatment paradigm for deep venous CVI, both for the millions of patients suffering from severe CVI and the thousands of vascular surgeons who have been waiting for an effective treatment option.”