Business
enVVeno Medical Reports Fourth Quarter and Year-End 2021 Financial Results and Provides Corporate Update
Ended the Year With $55 Million in Cash Expected To Fund Operations Through the End of 2024 Including Release of Topline Pivotal Trial DataNine (9) VenoValve
About this update from Envveno Medical Corporation
[{"type":"text","content":"Ended the Year With $55 Million in Cash Expected To Fund Operations Through the End of 2024 Including Release of Topline Pivotal Trial DataNine (9) VenoValve Surgeries Successfully Completed and 16 Clinical Sites Currently Active in Ongoing SAVVE U.S Pivotal TrialContinued Advancement in Development of Second Device for the Treatment of Venous Disease Expected To Be Unveiled in Mid-2022IRVINE, CA / ACCESSWIRE / March 28, 2022 / 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 2021.Recent HighlightsSuccessfully completed 9 VenoValve surgeries and 16 sites currently activated in the Company's SAVVE U.S. pivotal trial for the VenoValve;Presented positive long-term VenoValve first-in-human data at the 34th Annual Meeting of the American Venous Forum;Announced publication of one-year VenoValve data in the peer-reviewed journal, Vascular and Endovascular Surgery; andAnnounced ISO 13485 Quality Management System certification, representing an important step towards commercialization.The Company ended 2021 with approximately $55 million of cash and cash equivalents having raised in excess of $62 million of capital in 2021. The Company also had its Investigational Device Exemption (IDE) approved by the U.S. Food and Drug Administration (FDA) and began the U.S. pivotal trial for the VenoValve, the Company's lead product, which also received Breakthrough Device Designation from the FDA in 2021. As a late-stage clinical company, the Company's focus has begun to shift towards commercialization, and the requirements necessary to manufacture and distribute the VenoValve. In early 2022, the Company announced that it had received ISO 13485 certification for its Irvine facility covering the design, development, and manufacture of tissue based implantable medical devices. Progress has continued on a second product for the treatment of venous disease which the Company expects to announce in mid-2022.\"This past year was marked by execution in all critical areas of our business including financial, clinical, regulatory and operations. More recently, we worked through the challenges brought on by the COVID resurgence and are now seeing increased ...