Cash Burn of $5.2 million in Q4 remains in line with projected $4-5 million quarterly range Cash and investments on hand are sufficient to fund operations beyond the anticipated regulatory approval of VenoValve and the initiation of the enVVe pivotal trial PMA application for the VenoValve submitted, with FDA decision expected in the second half of 2025 On track for enVVe IDE application submission by mid-2025, pending GLP study results IRVINE, CA / ACCESS Newswire / February 28, 2025 / 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 2024. "Throughout 2024, we executed on our primary objectives - the successful submission of our PMA application for the VenoValve®, and the advancement of enVVe towards its U.S. pivotal trial, both critical milestones for enVVeno Medical," commented Robert Berman, CEO of enVVeno Medical.
On-demand video webcast now available here IRVINE, CA / ACCESS Newswire / February 19, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced it participated in the Virtual Investor "Top 5 for ‘25" On-Demand Conference . As part of the event, Robert Berman, Chief Executive Officer of enVVeno, presented the top five reasons of why he believes the investment community and industry colleagues should pay attention to the Company in 2025.
Interviews with participating patients from the VenoValve® U.S. Pivotal Trial Webcast replay from with the presenting Primary Investigators Presentation with data from the VenoValve U.S. Pivotal Trial Access the Recap Website Here! IRVINE, CA / ACCESSWIRE / November 27, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced the launch of a recap website which highlights the Company's participation at the recently held 51st Annual Vascular and Endovascular, Techniques and Horizons (VEITH) Symposium.
The FDA's approval of VenoValve's PMA has the potential to significantly expand NVNO's portfolio of bioprosthetic solutions.
85% Clinical Meaningful Benefit Responder Rate 7.91 Point Average rVCSS Improvement for the Clinically Meaningful Benefit Responder Cohort 75% Median Reduction in Pain (VAS) 87% Median Ulcer Area Reduction 97% Target Vein Patency Rate Improvement in All Patient Reported Quality-of-Life Indicators Company to Host Video Conference Call with VEITH Presenters Today at 2:00 PM Eastern Time - Click Here to Access IRVINE, CA / ACCESSWIRE / November 20, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, will present one year data on all subjects from the VenoValve U.S. pivotal trial today at the 51st Annual Vascular and Endovascular, Techniques and Horizons (VEITH) Symposium in New York City. The definitive one-year data supports the application submitted earlier this week by enVVeno Medical seeking pre-market authorization (PMA) from the U.S. Food and Drug Administration (FDA) to market and sell the VenoValve in the U.S. Among the data being presented at VEITH are: Eighty five percent (85%) of the subjects in the VenoValve pivotal study that reached the one-year milestone achieved a clinically meaningful benefit of a three (3) or more point improvement in revised Venous Clinical Severity Score (rVCSS).
Definitive One Year Data from PMA Application to be Presented Wednesday at 51st Annual VEITH Symposium Company to Host a Conference Call with the PIs Presenting the Pivotal Trial Data on Wednesday, November 20th at 2:00 PM Eastern Time - Click Here to Access IRVINE, CA / ACCESSWIRE / November 19, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced it has submitted its application with the U.S. Food and Drug Administration (FDA) seeking approval to market and sell the VenoValve in the United States. Four (4) out of five (5) modules that comprise the VenoValve PMA application have been submitted, reviewed and approved by the FDA.