Business
enVVeno Medical Reports Fourth Quarter and Year-End 2022 Financial Results and Provides Corporate Update
- Achieved more than half of enrollment in U.S. SAVVE pivotal trial of VenoValve® in 2022- Multiple near-term milestones expected across VenoValve® and enVVe™
About this update from Envveno Medical Corporation
[{"type":"text","content":"- Achieved more than half of enrollment in U.S. SAVVE pivotal trial of VenoValve® in 2022- Multiple near-term milestones expected across VenoValve® and enVVe™ clinical programs- Ended the year with $39.1 million in cash and investments including $3.6 million burn for Q4- Cash expected to support operations through the end of 2024, including release of SAVVE topline data and TAVVE first-in-human study dataIRVINE, CA / ACCESSWIRE / March 2, 2023 / enVVeno Medical Corporation (NASDAQ:NVNO) (\"enVVeno\" or the \"Company\"), a company setting new standards of care for the treatment of venous disease, today provided a corporate update and reported financial results for the fourth quarter and year-end of 2022.\"We made solid progress during the fourth quarter of 2022 and look forward to building momentum throughout 2023 as we approach several key clinical milestones for both the VenoValve and enVVe. To date, we have enrolled 43 patients in the SAVVE pivotal trial for the VenoValve. Industrywide hospital staffing turnover and shortages have slowed clinical trials across the U.S., including in SAVVE where enrollment has been somewhat inconsistent, even while patient interest is strong. During the fourth quarter of 2022 and first quarter of 2023, we added four full time clinical technologists to provide additional support to our clinical sites and to help with staffing issues. With topline safety data from SAVVE expected approximately 120 days after full enrollment, we still expect safety data to be available before the end of 2023,\" commented Robert Berman, CEO of enVVeno Medical.\"Additionally, we are waiting for regulatory approval to begin the first-in-human trial for enVVe, our next generation, non-surgical transcatheter based replacement venous valve. Enrollment for the enVVe first in-human study will begin immediately after regulatory approval and we expect to begin to report interim, topline data regarding technical success, safety, and effectiveness starting in the second half of 2023. With a number of near-term milestones ahead, 2023 is poised to be an exciting year,\" Mr. Berman added.Clinical Program HighlightsVenoValve®: Surgical Replacement Venous ValveThere are currently no effective treatments for patients with deep venous CVI resulting from malfunctioning valves.Approximately 2.5 million people in the U.S. have the type ...