enVVeno Medical Corporation announced that Principal Investigator Dr. Jorge Hernando Ulloa presented positive long-term, three-year observational data from a cohort of patients that participated in the previously concluded VenoValve first-in-human clinical trial. The data, which was presented at the 49th Annual VEITH Symposium in New York, showed that the VenoValve recipients, who are now an average of thirty-six (36) months post VenoValve implantation, continue to benefit from the VenoValve and have experienced no relapses of severe Chronic Venous Insufficiency (CVI) and no recurrences of venous ulcers. Safety events were limited to one (1) thrombosis after discontinuation of anti-coagulation medication.

Average improvements in reflux (the backwards flow of blood), CVI disease manifestations (rVCSS) and pain (VAS) remained stable at 63%, 52%, and 84% respectively, when compared to pre-surgery levels, for the cohort of eight (8) patients that agreed to be followed at conclusion of the one year first-in-human trial. One patient experienced an increase in rVCSS due to dermatitis, which is unrelated to the VenoValve or vascular disease. The average age of the patient group is sixty-eight (68), including one patient that is now eighty-nine (89) years old and another patient that is now eighty-five (85) years old.

The VenoValve is a first-in-class, surgically implanted replacement venous valve that is currently being evaluated in the SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis U.S. pivotal trial, a prospective, non-blinded, single arm, multi-center study of 75 CVI patients. CVI can cause the leg to swell, and blood vessels to break, resulting in discoloration, pain, and the breakdown of the skin leading to venous ulcers (open sores) which are difficult to heal. Patients with severe CVI have limited mobility and often experience difficulty standing, walking, and completing everyday tasks.

The Company estimates that approximately 2.5 million people in the U.S. that suffer from the debilitating impacts of severe deep venous CVI would be candidates for the VenoValve.