enVVeno Medical

NVNO

Market cap $7.75M

Moderated webcast with Robert Berman, Chief Executive Officer of enVVeno Medical on Wednesday, December 3rd at 4:00 PM ET IRVINE, CA / ACCESS Newswire / November 26, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno Medical" or the "Company"), today announced that Robert Berman, Chief Executive Officer of enVVeno Medical will participate in a Live Virtual Investor CEO Connect segment on Wednesday, December 3, 2025 at 4:00 PM ET. As part of the event, Mr.

IRVINE, CA / ACCESS Newswire / November 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 it has received an unfavorable decision from the U.S. Food & Drug Administration ("FDA") in response to its supervisory appeal of the not-approvable letter it received on August 19, 2025 in response to its Premarket Approval (PMA) application for VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI). The supervisory appeal upheld the review staff decision in the not-approvable letter that the VenoValve did not meet the standard of reasonable assurance of safety and effectiveness.

- Cash and investments are sufficient to fund current operations through Q2 2027, not including VenoValve commercialization and the enVVe IDE study - Cash burn of $4.2 million in Q3 remains in line with projected quarterly range - Ongoing engagement with FDA for supervisory appeal of the VenoValve PMA decision with feedback expected by the end of 2025 IRVINE, CA / ACCESS Newswire / October 31, 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 third quarter 2025. Summary of Financial Results for the Third Quarter 2025 The Company ended the quarter with $31.0 million in cash and investments.

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.