Business
enVVeno Medical Reports First Quarter 2024 Financial Results and Provides Corporate Update
- Ended the quarter with $42.9 million cash and investments on hand sufficient to fund current operations, including multiple value driving milestones,
About this update from Envveno Medical Corporation
[{"type":"text","content":"- Ended the quarter with $42.9 million cash and investments on hand sufficient to fund current operations, including multiple value driving milestones, through the end of 2025- Positive 11-month topline efficacy data presented at the 46th Annual Charing Cross Symposium- Company on track to file PMA Application seeking VenoValve® FDA approval in Q4 2024IRVINE, CA / ACCESSWIRE / May 8, 2024 / enVVeno Medical Corporation (Nasdaq:NVNO) (\"enVVeno\" or the \"Company\"), a company setting new standards of care for the treatment of venous disease, today reported financial results for the first quarter 2024.\"We continue to generate and present extremely encouraging data for the VenoValve at leading vascular conferences throughout the world and are in the final stages of accumulating the data necessary to file for PMA approval later this year. We recently added Andrew Cormack to our senior management team as our Chief Commercial Officer and will continue to make changes and additions to prepare for commercialization and what we hope will be FDA approval for the VenoValve,\" commented Robert Berman, CEO of enVVeno Medical. \"Importantly, we have maintained our strong financial position and moving forward, have the capital that we need to take the Company through several key milestones.\"Recent Corporate HighlightsAppointed Andrew Cormack as its Chief Commercial Officer.Clinical Program HighlightsVenoValve: Surgical Replacement Venous ValvePositive 11-month topline efficacy data from SAVVE showing significant clinical improvement from SAVVE U.S. pivotal trial presented 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 milestone8.08 points for patients at the one-year milestone8.71 points for patients at the six-month milestone94% 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.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.Total patient follow-up was 762 months and 582 months, r...