enVVeno Medical Corporation (NVNO)

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.

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).

IRVINE, CA / ACCESS Newswire / May 19, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, announced the appointment of Jennifer Bright as Chief Financial Officer, effective today, May 19, 2025. Ms. Bright brings more than 25 years of financial and strategic leadership experience built across several commercial-stage medical device and pharmaceutical companies including Biolase, Spectrum Pharmaceuticals, Apria Healthcare, Smile Brands, and Teleflex Medical, as well as technical accounting and auditing experience at PricewaterhouseCoopers LLP.

Promising results from the first-in-human study demonstrated that, at three-years post implantation, VenoValve remained safe and effective--achieving a high rate of patency, restoring deep venous competence and maintaining clinical benefits Company has submitted PMA application for the VenoValve to the U.S. Food and Drug Administration (FDA) with a decision anticipated in the second half of 2025 IRVINE, CA / ACCESS Newswire / May 13, 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 its manuscript titled, " Three-Year Outcomes of Surgical Implantation of a Novel Bioprosthetic Valve for the Treatment of Deep Venous Reflux 1," has been published in the in the peer-reviewed journal, Annals of Vascular Surgery. The VenoValve was surgically implanted in the femoral vein of eleven subjects with active or healed venous ulcers (CEAP classifications C5-C6).

Cash Burn of $4.0 million in Q1 remains in line with projected quarterly range Cash and investments on hand are sufficient to fund operations beyond the anticipated FDA decision of VenoValve and the initiation of the enVVe pivotal trial FDA decision on PMA application for the VenoValve expected in the second half of 2025 On track for enVVe IDE application submission in Q3 of 2025, pending GLP study results IRVINE, CA / ACCESS Newswire / May 1, 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 reported financial results for the first quarter 2025. Robert Berman, enVVeno Medical's Chief Executive Officer, commented "In the first quarter, we continued to present our compelling 1-year data from the U.S. pivotal trial at leading global, scientific conferences to socialize and engage directly with leading vascular surgeons as we lay the foundation for the potential phased market entry of the VenoValve, pending FDA approval.

IRVINE, CA / ACCESS Newswire / April 23, 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 the VenoValve® will be featured during a presentation at the Annual Charing Cross Symposium being held April 23-25, 2025 in London, England. As part of the Symposium, Dr. David Dexter, Sentara Hospital, Norfolk, Virginia and Associate Professor of Surgery, Eastern Virginia Medical School, and a Principal Investigator for the VenoValve U.S. pivotal trial, will present, "Progress to date and future prospects for invasive correction of deep venous reflux" onThursday, April 24, 2025 at 11:10 AM BST.

Moderated webcast with Robert Berman, Chief Executive Officer of enVVeno Medical on Tuesday, April 22nd at 4:00 PM ET IRVINE, CA / ACCESS Newswire / April 16, 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 that Robert Berman, Chief Executive Officer of enVVeno Medical will participate in the Virtual Investor Closing Bell Series on Tuesday, April 22, 2025 at 4:00 PM ET. As part of the event, Mr.

IRVINE, CA / ACCESS Newswire / March 31, 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 its abstract has been accepted for presentation at the Society for Clinical Vascular Surgery (SCVS) 52nd Annual Symposium being held March 29-April 2, 2025 in Austin, TX. As part of the SCVS Symposium, Dr. Cassius Iyad Ochoa Chaar, Associate Professor of Surgery, Yale School of Medicine, Division of Vascular and Endovascular Surgery, Principal Investigator, and lead enroller for the VenoValve U.S. pivotal trial, will present the abstract titled, " Impact of the VenoValve on Patients with Primary and Thrombotic Deep Venous Reflux " on Wednesday, April 2, 2025 beginning at 8:20 AM CT.

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.