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Positive Interim Venous Ulcer Healing Data Showing Significant Improvement from the enVVeno Medical VenoValve(R) Pivotal Trial to be Presented Today at the Society for Vascular Surgery 2024 Vascular Annual Meeting
91% of Venous Ulcer Patients Evaluated at One Year Have Either Fully Healed Ulcers or Ulcers That Have Improved100% of Venous Ulcers with a Duration of One
About this update from Envveno Medical Corporation
[{"type":"text","content":"91% of Venous Ulcer Patients Evaluated at One Year Have Either Fully Healed Ulcers or Ulcers That Have Improved100% of Venous Ulcers with a Duration of One Year or Less Prior to VenoValve Surgery Have Fully Healed89% of Venous Ulcers with a Duration of More Than One Year Prior to VenoValve Surgery Have Fully Healed or ImprovedNo Ulcer RecurrencesCompany on Track to File Application Seeking VenoValve FDA Approval in Q4 2024 IRVINE, CA / ACCESSWIRE / June 21, 2024 / enVVeno Medical Corporation (NASFAQ:NVNO) (\"enVVeno\" or the \"Company\"), a company setting new standards of care for the treatment of venous disease, today announced that positive interim venous ulcer healing data showing significant clinical improvement from the SAVVE U.S. pivotal trial for the VenoValve will be presented today at the Society for Vascular Surgery 2024 Vascular Annual Meeting in Chicago. The data being presented includes twenty-one venous ulcer patients who have now reached the one-year milestone, representing thirty venous ulcers. Overall, 91% of venous ulcer patients evaluated at one year have either fully healed ulcers or ulcers that have improved. Of that group, 100% of venous ulcers with a duration of one year or less prior to VenoValve surgery have fully healed, with the majority (67%) fully healed 90 days after VenoValve surgery. For venous ulcers with a duration of more than one year prior to VenoValve surgery, 89% have either fully healed or improved at one year, representing a decrease in average of total ulcer of 85%. In addition, none of the patients with a fully healed venous ulcer have experienced an ulcer recurrence.\"We are very pleased with the interim VenoValve ulcer healing data, especially when you consider this very difficult to treat population of patients who all failed conventional treatments such as wound care and compression therapy, and many of which did not respond to more invasive treatments for CVI such as ablation therapy for superficial disease and/or stenting for iliofemoral obstruction,\" said Robert Berman, enVVeno Medical's CEO. \"Our data shows the importance of the deep venous system to ulcer healing, supports the VenoValve as a part of a new treatment paradigm for the large population of patients with venous ulcers who have deep venous disease, and provides evidence that it is better to treat venous ulcer patie...