enVVeno Medical presents one-year data from VenoValve trial

enVVeno Medical (NVNO) announced that one-year follow-up data on 75 subjects from the VenoValve U.S. pivotal trial will be presented by Dr. Cassius Iyad Ochoa Chaar, Associate Professor Surgery, Yale School of Medicine, Division of Vascular and Endovascular Surgery, Principal Investigator, and lead enroller for the trial, at the 37th Annual Meeting of the American Venous Forum being held February 16-19, 2025 in Atlanta, GA. The presentation is scheduled for 9:47 AM ET. The data show that trial subjects who had the SAVVE procedure experienced statistically significant improvements in QoL metrics related to venous disease at 12 months compared to baseline as demonstrated by the VEINS-SYM/QOL scores. The Company has submitted a pre-market authorization application for the VenoValve to the U.S. Food and Drug Administration, with a decision anticipated in the second half of 2025. “We continue to be asked to present our data at leading vascular conferences throughout the world as news of the potential for the VenoValve spreads among vascular surgeons whose practices include the treatment of venous diseases,” said Robert Berman, CEO. “The VenoValve has the potential to be the first FDA approved treatment for deep venous CVI, and we are attempting to reach the top of a mountain that nobody has successfully climbed and with many failed attempts over the past several decades. With the summit of the mountain finally in sight, this is an exciting time for our company and for the millions of patients with severe deep venous CVI who have no effective treatment options.”