enVVeno Medical (NVNO)
Develops a catheter-delivered tissue valve for severe deep chronic venous insufficiency.
Independent Health Economic Study Recently Published in Journal of Vascular Surgery Reports Economic Dominance of enVVeno Medical's Replacement Venous Valve Therapy Compared to Standard of Care Treatments
Published economic health study shows both short- and long-term cost-effectiveness of replacement venous value therapy versus standard-of-care treatments for deep venous CVI, generating compelling evidence that will be used to support future coverage determinations and reimbursement policies for enVVeno Medical's enVVe non-surgical replacement venous valve Publication Highlights: Peer-reviewed publication in the Journal of Vascular Surgery: Venous and Lymphatic Disorders More than $32,000 projected healthcare savings per patient over five years Approximately 2.2 fewer venous ulcers per patient compared to standard of care Approximately $4,100 projected cost savings per each rVCSS* point of clinical improvement Economically dominant versus compression therapy and wound care in the modeled analysis Approximately $5.9 billion estimated annual healthcare savings with broader adoption of effective venous valve replacement therapy *rVCSS (revised Venous Clinical Severity Score) is a validated clinical tool used to evaluate disease severity and treatment response in patients with chronic venous disease. IRVINE, CA / ACCESS Newswire / August 4, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), today highlighted the publication of a landmark, peer-reviewed health economic analysis in the Journal of Vascular Surgery: Venous and Lymphatic Disorders demonstrating the potential clinical and economic benefits of venous valve replacement therapy for patients with severe deep venous reflux.
enVVeno Medical Reports Second Quarter 2026 Financial Results and Advances Towards FDA Pivotal Trial for First-in-Class Non-Surgical Replacement Venous Valve
Company Enters the Second Half of 2026 With Tailwinds From an FDA IDE Approval, With the TAVVE Pivotal Study Expected to Begin Enrolling Patients During the Second Half of This Year and Cash Runway Extending Into the Third Quarter of 2027 IRVINE, CA / ACCESS Newswire / July 31, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), today reported financial results for the second quarter ended June 30, 2026, and highlighted by the significant regulatory milestone of receiving U.S. Food and Drug Administration (FDA) IDE approval to begin the TAVVE® pivotal trial for its enVVe® System, a first-in-class, minimally invasive replacement venous valve for patients suffering from severe deep chronic venous insufficiency (CVI). Second Quarter 2026 Highlights Achieved first-ever FDA IDE approval for a U.S. pivotal study evaluating a transcatheter replacement venous valve for severe deep CVI.
enVVeno Medical Highlights Newly Issued U.S. Patent Strengthening Competitive Position Ahead of Historic Pivotal Trial in Virtual Investor "What This Means" Segment
CEO Explains How Broad Patent Protection, Combined with First-Ever FDA IDE Approval, Positions enVVe® to Own a Multi-Billion-Dollar Venous Disease Market Watch the "What This Means" video here IRVINE, CA / ACCESS Newswire / July 15, 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.
enVVeno Medical Secures Transformational U.S. Patent for enVVe System, Strengthening Competitive Moat Ahead of Launch of Historic FDA Pivotal Trial
New Patent Broadly Protects Core Technology Behind Potential First Non-Surgical Replacement Venous Valve Builds on First-Ever FDA IDE Approval for Pivotal Study of enVVe System Targeting Multi-Billion-Dollar Market Opportunity enVVe Pivotal Study on Track for Enrollment to Commence and First Patients Data Release Expected by the End of Q4 2026 IRVINE, CA / ACCESS Newswire / July 7, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company") today announced the issuance of U.S. Patent No. 12,575,932, further expanding its intellectual property portfolio supporting its enVVe® transcatheter replacement venous valve system for the treatment of venous disease.
enVVeno Medical to Present in the Webull Corporate Connect Webinar Series
- Live webcast on Wednesday, June 24th at 2:00 PM ET - Access the event here IRVINE, CA / ACCESS Newswire / June 22, 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 it will present in the Webull Corporate Connect Webinar Series being held virtually June 24-25, 2026. As part of the discussion, the Company's CEO, Rob Berman, will provide an overview of enVVeno Medical's mission to transform the treatment of deep venous disease, discuss the significant unmet need for patients suffering from severe Deep Venous Insufficiency (DVI), review the recent FDA IDE approval for the Company's enVVe® System, and outline plans for advancing the first-ever U.S. pivotal trial of a non-surgical replacement venous valve.
enVVeno Medical to Participate in the Virtual Investor Closing Bell Series
Live video webcast with Robert Berman, Chief Executive Officer of enVVeno Medical, on Tuesday, June 9that 4:00 PM ET Register here IRVINE, CA / ACCESS Newswire / June 2, 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 Robert Berman, Chief Executive Officer of enVVeno Medical will participate in a Virtual Investor Closing Bell event on Tuesday, June 9, 2026 at 4:00 PM ET. As part of the event, Mr.
enVVeno Medical Discusses FDA IDE Approval in Virtual Investor "What This Means" Segment
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.
enVVeno Medical Reports First Quarter 2026 Financial Results and Provides Business Update Highlighting Strategic Advancement of the enVVe System
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.
enVVeno Medical Receives First-Ever FDA IDE Approval for a U.S. Pivotal Study of a Non-Surgical Replacement Venous Valve
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).
NorthStrive Fund II LP Calls on enVVeno Medical to Halt Clinical Spending Plans and Call Special Shareholder Meeting to Vote on Strategic Alternatives
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:
enVVeno Medical Stock Set to Reverse Split on Tuesday, January 20th (NASDAQ:NVNO)
enVVeno Medical Corporation (NASDAQ: NVNO)'s stock is going to reverse split on the morning of Tuesday, January 20th. The 1-35 reverse split was recently announced. The number of shares owned by shareholders will be adjusted after the closing bell on Monday, January 19th. enVVeno Medical Trading Down 13.2% Shares of NASDAQ: NVNO opened at
enVVeno Medical Announces Reverse Stock Split
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.
enVVeno Medical (NASDAQ:NVNO) to Participate in a Live Virtual Investor CEO Connect Segment
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.
enVVeno Receives Unfavorable Appeal Decision from the FDA for the VenoValve
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.
enVVeno Medical Reports Third Quarter 2025 Financial Results and Provides Corporate Update
- 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.
enVVeno Medical (NASDAQ:NVNO) Participates in Virtual Investor "What This Means" Segment
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.
NVNO's Shares Decline on Unfavorable FDA Review Outcome for VenoValve
enVVeno Medical shares plunge after the FDA rejects its VenoValve PMA, citing insufficient trial data and safety concerns tied to the surgical procedure.
enVVeno Medical to Present at the Webull Financial Corporate Connect Webinar Series: Biotech/MedTech
- 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.
enVVeno Medical Reports Second Quarter 2025 Financial Results and Provides Corporate Update
- 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.
enVVeno Medical Participates in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference
- 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.