enVVeno Medical Reports Third Quarter 2021 Financial Results and Provides Corporate Update
- Quarter marked by corporate rebranding and strategic prioritization of development programs- Company executing on SAVVE U.S pivotal trial evaluating lead product, the VenoValve®, as a potential treatment for severe deep venous Chronic Venous …
- Quarter marked by corporate rebranding and strategic prioritization of development programs
- Company executing on SAVVE U.S pivotal trial evaluating lead product, the VenoValve®, as a potential treatment for severe deep venous Chronic Venous Insufficiency (CVI)
- Bolstered cash position with recently completed $20 million registered direct offering with leading life sciences investment firm
IRVINE, CA / ACCESSWIRE / November 11, 2021 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today reported its financial results for the quarter ended September 30, 2021.
The Company also provided an update on its lead product, the VenoValve®, a first-in-class implant being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI).
- Successfully completed the first VenoValve surgery in the SAVVE U.S. pivotal trial;
- Closed a $20 million registered direct offering priced at-the-market under NASDAQ rules with a fund managed by Perceptive Advisors, a leading life sciences investment firm;
- Presented positive two-year post-VenoValve implantation data at the Society for Vascular Surgery® (SVS) Annual Meeting in San Diego, CA; and
- Received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) for the VenoValve.
"We have made significant progress on all strategic fronts over the past quarter. The launch of the SAVVE pivotal trial was a monumental achievement for the Company which represents the last study needed before we are able to submit for premarket approval of the VenoValve with the FDA," commented enVVeno Medical CEO Robert Berman. "On the financial front, we have never been stronger. Having secured an additional $20 million in financing from a leading healthcare institutional investor, we now have sufficient capital to fund operations through what we hope will be regulatory approval of the VenoValve. Lastly, we realigned our corporate identity and now have a brand that reflects our overall mission and goals to establish enVVeno as a global leader for venous care."