enVVeno Medical Corporation
NASDAQ Capital MarketCapital Structure
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in mil. unless spec.Company Description
- CEO
- Robert A. Berman
- Full Time Employees
- 33
- Sector
- Healthcare
- Industry
- Medical - Devices
- Address
- 70 Doppler Irvine CA United States of America 92618
- IPO Date
- May 31, 2018
- CIK
- 0001661053
- Website
- envveno.com
- Similar Companies
- Business
- enVVeno Medical Corporation (Nasdaq: NVNO) is an Irvine, California-based, late clinical-stage medical device company focused on the development of innovative bioprosthetic tissue-based solutions to improve the standard of care for venous disease, particularly deep venous chronic venous insufficiency (CVI); the company's lead product, VenoValve, comprises a first-in-class surgical replacement venous valve implanted into the femoral vein via a 5-to-6-inch incision in the upper thigh to restore one-way blood flow, alleviate reflux, reduce venous hypertension, and heal ulcers in patients who have failed standard-of-care treatments; enVVe represents a non-surgical, transcatheter-based replacement venous valve system including the enVVe valve, delivery system, and accessories, designed for minimally invasive deployment to treat severe CVI by propelling blood up the leg to the heart and lungs. Incorporated in 1999 and formerly known as Hancock Jaffe Laboratories, Inc. until its rebranding in October 2021, enVVeno operates primarily in the United States with an estimated addressable market of 2.5 million to 3.5 million severe CVI patients annually, targeting vascular surgeons and patients with venous reflux, pooling, hypertension, and chronic ulcers through its SAVVE U.S. pivotal trial for VenoValve, which has demonstrated significant clinical improvements in revised Venous Clinical Severity Scores, pain reduction, and quality-of-life metrics at one and two years. Recent developments include the submission of a Premarket Approval (PMA) application for VenoValve with an initial FDA decision anticipated in the second half of 2025, followed by receipt of a not approvable letter on August 19, 2025 citing insufficient hemodynamic data to support the benefit-risk profile despite positive SAVVE trial outcomes, an unfavorable appeal decision on November 13, 2025, and ongoing evaluation of resubmission options; the company successfully initiated and advanced its six-month pre-clinical GLP study for enVVe with first-wave implants completed and final pathology pending, positioning it to file an Investigational Device Exemption (IDE) for the enVVe pivotal trial by mid-2025; quarterly financial updates reflect cash positions of $35.1 million at Q2 2025 end and $31.0 million at Q3 2025 end to support commercialization preparations, regulatory responses, and enVVe development amid net losses.
Company News
enVVeno Medical Participates in the Virtual Investor 'Why Now' On-Demand Conference
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
enVVeno Medical Reports Second Quarter 2026 Financial Results and Advances Towards FDA Pivotal Trial for First-in-Class Non-Surgical Replacement Venous Valve
enVVeno Medical Highlights Newly Issued U.S. Patent Strengthening Competitive Position Ahead of Historic Pivotal Trial in Virtual Investor "What This Means" Segment
enVVeno Medical Secures Transformational U.S. Patent for enVVe System, Strengthening Competitive Moat Ahead of Launch of Historic FDA Pivotal Trial
enVVeno Medical to Present in the Webull Corporate Connect Webinar Series
enVVeno Medical to Participate in the Virtual Investor Closing Bell Series
enVVeno Medical Discusses FDA IDE Approval in Virtual Investor "What This Means" Segment
enVVeno Medical Reports First Quarter 2026 Financial Results and Provides Business Update Highlighting Strategic Advancement of the enVVe System
enVVeno Medical Receives First-Ever FDA IDE Approval for a U.S. Pivotal Study of a Non-Surgical Replacement Venous Valve
enVVeno Medical Reports Full Year 2025 Financial Results and Highlights Strategic Advancement of enVVe(R) System
NorthStrive Fund II LP Calls on enVVeno Medical to Halt Clinical Spending Plans and Call Special Shareholder Meeting to Vote on Strategic Alternatives
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Head to Head Analysis: LENSAR (NASDAQ:LNSR) versus enVVeno Medical (NASDAQ:NVNO)
enVVeno Medical Regains Compliance with Nasdaq Minimum Bid Price Requirement
enVVeno Medical Stock Set to Reverse Split on Tuesday, January 20th (NASDAQ:NVNO)
enVVeno Medical Announces Reverse Stock Split
enVVeno Medical (NASDAQ:NVNO) to Participate in a Live Virtual Investor CEO Connect Segment
enVVeno Receives Unfavorable Appeal Decision from the FDA for the VenoValve
enVVeno Medical Reports Third Quarter 2025 Financial Results and Provides Corporate Update