Business
enVVeno Medical Reports Third Quarter 2023 Financial Results and Provides Corporate Update
- $51.4 million cash on hand sufficient to fund current operations, including multiple value driving milestones, through the end of 2025- Achieved full
About this update from Envveno Medical Corporation
[{"type":"text","content":"- $51.4 million cash on hand sufficient to fund current operations, including multiple value driving milestones, through the end of 2025- Achieved full enrollment for VenoValve® U.S. pivotal trial- Expedited development plan for the enVVe® transcatheter-based replacement venous valveIRVINE, CA / ACCESSWIRE / October 26, 2023 / 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 third quarter ended September 30, 2023. Cash burn for the quarter was $4.1 million, which is in line with the Company's previous guidance of burning between $4 million and $5 million per quarter. \"Our team has continued to make significant progress on multiple fronts while keeping our cash burn in line with previous guidance. Notably, we reached full enrollment, ahead of schedule, in the VenoValve U.S. pivotal trial, further strengthened our balance sheet with the closing of a $28 million private placement on terms that are favorable to both the company and investors, and in light of our stronger cash position, announced our plans to expedite the development of enVVe, our transcatheter replacement venous valve,\" commented Robert Berman, CEO of enVVeno Medical. \"Although we expect our quarterly cash burn to begin to increase over time as we get closer to commercialization of the VenoValve, we now have the capital that we need to get us past several significant milestones, including what we expect will be regulatory approval of the VenoValve and the beginning the enVVe pivotal trial.\"Clinical Program HighlightsVenoValve®: Surgical Replacement Venous ValveAchieved completion of enrollment in the SAVVE U.S. pivotal study.Initial topline safety data from SAVVE is now expected in Q4 of this year.Initial topline efficacy data from SAVVE is now expected in Q2 of 2024.PMA eligibility to file for FDA approval of the VenoValve is expected to occur in Q3 of 2024.enVVe®:Non-Surgical Transcatheter Based Replacement Venous ValveSix-month GLP study (final step before seeking pivotal study approval) to begin in Q1 of 2024.IDE application seeking approval for enVVe pivotal trial expected to be filed in Q4 of 2024.Approval for enVVe pivotal study expected in early 2025.Summary of Financial Results for the Third Quarter 2023The Com...