enVVeno Medical

NVNO

Market cap $6.55M

First-Ever FDA IDE Approval for a U.S. Pivotal Study of a Non-surgical Replacement Venous Valve IDE approval positions enVVeno to advance what could become the first effective treatment option for the approximately 3 million U.S. patients suffering from DVI Watch the "What This Means" video here IRVINE, CA / ACCESS Newswire / May 12, 2026 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno Medical" or the "Company"), 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.

Company ended the first quarter with approximately $25 million in cash and investments Capital on hand should fund operations through multiple key milestones into Q3 2027 Company recently received FDA IDE approval to commence TAVVE U.S. Pivotal Study for non-surgical replacement venous valve, enVVe System TAVVE site selection is underway with patient enrollment expected to commence later this year IRVINE, CA / ACCESS Newswire / May 7, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), today reported financial results for the first quarter 2026, ending the quarter with approximately $25 million in cash and investments and confirming the Company's strategic focus on the development of its next-generation enVVe® System for the treatment of deep venous insufficiency. "With a strong balance sheet, significant physician interest in the enVVe valve, and a clearly defined regulatory pathway, we are well positioned to execute the TAVVE study and advance the Company towards multiple near-term and long-term milestones," said Robert Berman, Chief Executive Officer of enVVeno Medical.

First-in-Class enVVe system to be evaluated in TAVVE U.S. Pivotal Trial Clinical site activation and patient enrollment expected to commence later this year Large unmet clinical need for approximately 3 million U.S. patients with severe deep Chronic Venous Insufficiency Potential multi-billion-dollar untapped U.S. market Company has approximately $25 million in cash and investments to fund operations into Q3 2027 IRVINE, CA / ACCESS Newswire / April 29, 2026 / 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 U.S. Food and Drug Administration (FDA) has awarded the Company the first-ever IDE approval to proceed with a U.S. pivotal study of a non-surgical replacement venous valve. The Transcatheter Venous Valve Endoprosthesis (TAVVE®) pivotal study will evaluate the Company's minimally invasive enVVe® System for patients with severe deep Chronic Venous Insufficiency (CVI).

Company accelerated development of the enVVe® System, completing pre-clinical studies and progressing toward a 2026 pivotal trial initiation Strong financial position expected to provide an operating runway into mid-2027 through the achievement of key clinical milestones IRVINE, CA / ACCESS Newswire / March 27, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), today announced financial results for the year ended December 31, 2025 and provided a corporate update highlighting its strategic focus on the development of its next-generation enVVe® System. Robert Berman, Chief Executive Officer of enVVeno Medical Corporation, stated, "2025 represented a significant inflection point for the Company.

NEWPORT BEACH, Calif., March 03, 2026 (GLOBE NEWSWIRE) -- NorthStrive Fund II LP (“NorthStrive Fund II”), a subsidiary of NorthStrive Companies Inc., headquartered in Newport Beach, California, and beneficial owner of approximately 5.05% of the outstanding common stock of enVVeno Medical Corporation (“enVVeno” or the “Company”), today issued the following open letter to the Company's Board of Directors (the “Board”) and fellow shareholders:

Company achieves minimum $1.00 closing bid for 10 consecutive business days; Nasdaq confirms matter is closed Reports Cash and Investments of approximately $28 million as of the Year Ended December 31, 2025 IRVINE, CA / ACCESS Newswire / February 4, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), today announced that it has received formal notice from the Listings Qualifications staff of The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2), which requires a minimum bid price of $1.00 per share. Nasdaq confirmed that for the last 10 consecutive business days, from January 20, 2026 through February 2, 2026, the closing bid price of the Company's common stock was at or above $1.00, and as a result, the matter is now closed.

IRVINE, CA / ACCESS Newswire / January 15, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), today announced that the Company's Board of Directors has approved a reverse stock split of its shares of common stock at a ratio of 1 for 35 (the "Reverse Stock Split"). The Reverse Stock Split will become effective at 12:01 a.m.

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.