enVVeno Medical

NVNO

Market cap $14.3M

Watch the "What This Means" video here IRVINE, CA / ACCESS Newswire / September 26, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that Robert Berman, Chief Executive Officer of enVVeno Medical participated in a Virtual Investor "What This Means" segment. As part of the segment, Mr.

IRVINE, CA / ACCESS Newswire / September 15, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it will file a request for supervisory appeal of the not-approvable letter from the Center for Devices and Radiological Health (CDRH) of the U.S. Food & Drug Administration (FDA) received on August 19, 2025, in response to its Premarket Approval (PMA) application for the VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI). The FDA provides several internal informal and formal mechanisms to challenge lower review staff decisions, including scientific controversies.

enVVeno Medical shares plunge after the FDA rejects its VenoValve PMA, citing insufficient trial data and safety concerns tied to the surgical procedure.

IRVINE, CA / ACCESS Newswire / August 20, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it has received a not-approvable letter from the U.S. Food & Drug Administration (FDA) in response to its Premarket Approval (PMA) application for VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI). The letter indicates that the FDA completed its review of the VenoValve PMA application and determined that it is unable to approve the PMA for the VenoValve in its current form.

- Live webcast on Thursday, August 21stat 2:00 PM ET IRVINE, CA / ACCESS Newswire / August 15, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it will present at the Webull Financial Corporate Connect Webinar Series: Biotech/MedTech being held virtually August 19-21, 2025. Details for the presentation are as follows: Date and Time: Thursday, August 21, 2025 at 2:00 PM ET Presenter: Robert Berman, enVVeno Medical's Chief Executive Officer Registration Link: HERE About Webull Financial Webull Financial is a leading online brokerage platform committed to empowering self-directed investors with innovative tools and cutting-edge technology.

Clinical data and cost-effectiveness analysis demonstrates the VenoValve would provide both better health outcomes and lower costs compared to current standard of care treatments The VenoValve could potentially save $5.9 billion annually in healthcare costs for the approximately 2.5 million U.S. patients with severe CVI Company to host live webcast with lead author of the cost-analysis manuscript, today, August 6th, at 12:00 PM ET; Access the Webcast Here IRVINE, CA / ACCESS Newswire / August 6, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announcedpreliminary findings from a VenoValve health economic study, which indicate that the VenoValve would be a cost-effective treatment option for patients with severe Chronic Venous Insufficiency (CVI) caused by deep valvular incompetency. The Company announced it will host a live webcast to discuss the cost-effectiveness analysis results today, Wednesday, August 6th at 12:00 PM ET (details below).

- enVVeno is developing the VenoValve as a potential treatment option for the approximately 2.5 million patients in the U.S. suffering from severe deep Chronic Venous Insufficiency - FDA decision expected in 2H'2025 - Access the "What This Means" segment here IRVINE, CA / ACCESS Newswire / August 4, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno Medical" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it participated in a Virtual Investor "What This Means" segment entitled, "enVVeno Medical - Making Veins Work Again - How President Trump's CVI Diagnosis is Raising Awareness." Rob Berman, CEO and Dr. Marc Glickman, CMO of enVVeno Medical discussed the progressive nature of chronic veinous insufficiency and whether President Trump may one day be a candidate for the VenoValve® following U.S. Food and Drug Administration (FDA) approval.

- Cash burn of $3.8 million in Q2 remains in line with projected quarterly range - Cash and investments are sufficient to fund operations through Q3'2026 at current cash burn rate - Commercial readiness activities underway for a phased launch of VenoValve® subject to FDA decision expected in 2H'2025 - IDE submission for enVVe® on track for 2H'2025 IRVINE, CA / ACCESS Newswire / August 1, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today reported financial results for the second quarter 2025. "As the recent headlines around CVI confirmed, CVI is a pervasive and a progressive disease that is especially debilitating once it becomes severe.

- Video webcast now available on-demand IRVINE, CA / ACCESS Newswire / July 22, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that Rob Berman, CEO of enVVeno, participated in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference. As part of the segment, Mr.

Interim two-year follow-up data from 42 subjects in the VenoValve pivotal trial show sustained clinical improvement and continued patient benefit at 24 months compared to baseline 83% of subjects maintained a clinically meaningful benefit with a 3 or more point improvement in Revised Venous Clinical Severity Score (rVCSS) 9.1 point average rVCSS improvement among the clinically meaningful benefit cohort Subjects experienced a median 74% improvement in leg pain Interim follow-up data indicate sustained improvements across all venous-specific quality-of-life (QoL) indicators A decision from the U.S. Food and Drug Administration (FDA) on the VenoValve is anticipated in the second half of 2025 Company to host live webcast with presenting Principal Investigator, today, June 6th at 11:20 AM ET / 10:20 AM CT - Access the Webcast Here IRVINE, CA / ACCESS Newswire / June 6, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that interim two-year follow-up data on 42 subjects from the 75 person VenoValve U.S. pivotal trial will be presented today by lead enroller Dr. Cassius Iyad Ochoa Chaar, at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting (VAM25) being held June 4-7, 2025 in New Orleans, LA. Additionally, the Company announced it will host a live webcast to discuss these interim results today, Friday, June 6th at 11:20 AM ET / 10:20 AM CT (details below).