Positive 11 Month Topline Efficacy Data Showing Significant Clinical Improvement from enVVeno Medical's VenoValve(R) Pivotal Trial to be Presented Today at the 46th Annual Charing Cross Symposium

• Overall 8.46 Average Revised Venous Clinical Severity Score (rVCSS) Improvement Per Patient for Patients Showing Clinical Meaningful Benefit (rVCSS Improvement ≥ 3 Points) including:
  • 9.29 Points for Patients at the Two-Year Milestone
  • 8.08 Points for Patients at the One-Year Milestone
  • 8.71 Points for Patients at the Six-Month Milestone
• 72% of the Study Patients Showing Clinical Meaningful Benefit from the VenoValve at a Weighted Average of 11 Months Post Surgery
• 94% of VenoValve Study Patients Showing Clinical Improvement at a Weighted Average of Eleven Months Post Surgery (rVCSS Improvement ≥ 1 point)
• Company on Track to File Application Seeking VenoValve FDA Approval in Q4 2024

IRVINE, CA / ACCESSWIRE / April 24, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced the presentation of positive topline efficacy data showing significant clinical improvement from the SAVVE U.S. pivotal trial for the VenoValve at the 2024 Charing Cross International Symposium in London, UK.

Foto: Accesswire

The data being presented shows that for patients experiencing a Clinical Meaningful Benefit (Revised Venous Clinical Severity Score (rVCSS) improvement ≥ 3 points), the overall average rVCSS improvement was 8.46 points, including 9.29 points for patients at the two-year milestone, 8.08 points for patients at the one-year milestone, and 8.71 points for patients at the six-month milestone. All rVCSS evaluations were based on the patient's most recent clinical visit, compared to baseline, for a weighted average of eleven months following VenoValve implantation for the Clinical Meaningful Benefit patient cohort.

Overall, 94% of the study patients receiving the VenoValve have shown clinical improvement as measured by rVCSS at a weighted-average patient follow-up of 11.04 months for the clinical improvement cohort, and 72% of the study patients have improved the three or more rVCSS points needed to demonstrate the VenoValve's Clinical Meaningful Benefit, at a weighted-average patient follow-up of 11.64 months for the Clinical Meaningful Benefit cohort. Total patient follow-up was 762 months and 582 months, respectively, for the two patient cohorts.