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Positive 3-Year VenoValve(R) First-in-Human Data Presented at 49th Annual VEITH Symposium on Vascular and Endovascular Issues
First-in-Human VenoValve recipients continue to benefit from VenoValve at average of 3 years post-surgeryNo venous ulcer recurrences or CVI relapsesStability
About this update from Envveno Medical Corporation
[{"type":"text","content":"First-in-Human VenoValve recipients continue to benefit from VenoValve at average of 3 years post-surgeryNo venous ulcer recurrences or CVI relapsesStability in improvements for all study endpoints including reflux, disease severity (rVCSS), and pain (VAS)IRVINE, CA / ACCESSWIRE / November 17, 2022 / enVVeno Medical Corporation (NASDAQ:NVNO) (\"enVVeno\" or the \"Company\"), a company setting new standards of care for the treatment of venous disease, today 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 sixty three percent (63%), fifty two percent (52%), and eighty four percent (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.\"We are extremely pleased that our VenoValve first-in-human patients continue to benefit from the VenoValve surgeries that occurred three years ago and that these patients are no longer burdened by the debilitating impacts from severe CVI,\" said Robert Berman, enVVeno Medical's Chief Executive Officer. \"Our goal is to help millions of patients that suffer from debilitating CVI and currently have no effective treatment options.\"The VenoValve is a first-in-class, surgically implanted replacement venous valve that is currently being evalua...