enVVeno Medical Corporation
enVVeno Medical Corporation is a clinical-stage medical device company developing bioprosthetic replacement venous valves — VenoValve (surgical) and enVVe (transcatheter) — for treating severe Chronic Venous Insufficiency in deep leg veins, targeting an estimated 2.5–3.5 million U.S. patients.
- Company typePublic
- Founded1999
- HeadquartersIrvine, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What enVVeno Medical Corporation does
enVVeno Medical Corporation (NASDAQ: NVNO), headquartered in Irvine, California, is a clinical-stage medical device company developing bioprosthetic (tissue-based) replacement venous valves for the treatment of Chronic Venous Insufficiency (CVI) in the deep veins of the leg. The company was originally incorporated in Delaware in 1999 as Hancock Jaffe Laboratories and was renamed enVVeno Medical in October 2021. Its two core products are VenoValve, a first-in-class surgical replacement venous valve (the subject of the completed SAVVE U.S. pivotal study), and enVVe, a next-generation non-surgical transcatheter replacement venous valve featuring a self-expanding nickel-titanium frame, a porcine pericardium mono-cusp leaflet, and a 13 Fr delivery profile — the smallest of any cardiovascular replacement valve. Both devices are designed as one-way valves to propel venous blood from the lower extremity back to the heart, addressing an estimated 2.5 to 3.5 million U.S. patients with severe CVI for whom no approved replacement valve currently exists.
The company is pre-revenue and has not commercialized any product. Its near-term value drivers are regulatory milestones: in April 2026 it received the first-ever FDA IDE approval for a U.S. pivotal study of a non-surgical replacement venous valve (the TAVVE trial for enVVe, enrolling 230 patients across up to 40 sites), while simultaneously facing an FDA rejection of its Premarket Approval application for VenoValve. Operations are funded by equity — cumulative raises of approximately $63 million since 2021 (including $20M with Perceptive Advisors in 2021, $28M from healthcare-focused institutions in 2023, and $15M led by Titan Partners in 2024) — leaving $24.9M in cash at Q1 2026, with management guiding runway into mid-2027. A 2025 net loss of $19.5M (down from $21.8M in 2024) reflects declining R&D spend of $10.0M, and in January 2026 the company executed a 1-for-35 reverse stock split to maintain Nasdaq compliance. Activist shareholder NorthStrive Fund II (~5.05% stake) has publicly pressed for a strategic alternatives review.
enVVeno Medical Corporation firmographics
Firmographics- Name
- enVVeno Medical Corporation
- Legal name
- enVVeno Medical Corporation
- Website
- https://envveno.com
- Company type
- Public
- Founded year
- 1999
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- enVVeno Medical Corporation is a clinical-stage medical device company developing bioprosthetic replacement venous valves — VenoValve (surgical) and enVVe (transcatheter) — for treating severe Chronic Venous Insufficiency in deep leg veins, targeting an estimated 2.5–3.5 million U.S. patients.
- Ownership category
- akta.pro rank
enVVeno Medical Corporation industry classification
Industry- Product category
- Cardiovascular Medical Devices
- NAICS
- Surgical and Medical Instrument Manufacturing (339112)
- SIC
- Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Structural Heart Valves (TAVR/SAVR) & Valve Repair (HLAHAFAB)
- akta.pro secondary industries
- Thrombectomy, Embolic Protection & Stroke Intervention Devices (HLAHAFAJ), Cardiac Surgery Devices (Cannulas, Clamps, Closure, Grafts) (HLAHAFAH)
Keywords
Where enVVeno Medical Corporation is headquartered
LocationHeadquarters
- HQ city
- Irvine
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
enVVeno Medical Corporation business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Marketing or Sales, Operations, Others
Revenue model
- Medical Device Commercialization (Future): The company is pre-revenue as both VenoValve and enVVe are investigational devices not yet approved for commercial sale. Once FDA approval is obtained, the company plans to commercialize its replacement venous valve products for treatment of Chronic Venous Insufficiency.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels5 records
enVVeno Medical Corporation product offering
Product offeringCore offering
enVVeno Medical develops bioprosthetic (tissue-based) replacement venous valves for the treatment of Chronic Venous Insufficiency (CVI) caused by incompetent valves in the deep veins of the leg. Its two investigational products are the VenoValve, a first-in-class surgical replacement venous valve currently evaluated in the SAVVE U.S. pivotal study, and the enVVe System, a next-generation non-surgical, transcatheter-based replacement venous valve with FDA IDE approval for the TAVVE pivotal study. Both are designed as one-way valves to propel blood from the leg back to the heart and lungs.
Product overview
enVVeno Medical Corporation is a clinical-stage medical device company developing two distinct replacement venous valve products for the treatment of chronic venous insufficiency (CVI): VenoValve, a first-in-class surgical replacement venous valve currently in the SAVVE pivotal trial, and enVVe, a next-generation non-surgical transcatheter-based valve in the TAVVE pivotal trial. Both products are bioprosthetic (tissue-based) devices designed to act as one-way valves to help propel blood from the leg back to the heart and lungs.
Differentiator
Problem solved
Functional benefit
Brands
- enVVe: Next-generation, non-surgical, transcatheter-based replacement venous valve for treatment of Chronic Venous Insufficiency (CVI) in the deep veins of the leg.
- VenoValve
Products and services
- VenoValve First-in-class surgical replacement venous valve, made from bioprosthetic tissue, for treatment of Chronic Venous Insufficiency (CVI) in the deep veins of the leg. Acts as a one-way valve to help propel blood up the leg back to the heart and lungs. Targeted at vascular surgery specialists and their patients with severe CVI.
- enVVe System Next-generation, non-surgical, transcatheter-based replacement venous valve for treatment of Chronic Venous Insufficiency (CVI) of the deep veins of the leg. Features a self-expanding frame made from biocompatible nickel and titanium alloy, a mono-cusp leaflet laser-cut from porcine pericardium tissue, and a 13 Fr delivery profile (the smallest of any cardiovascular replacement valve). Procedure is performed in an Angio Suite under light sedation with no overnight hospital stay. Targeted at vascular specialists and patients with severe CVI who are candidates for a minimally invasive therapy.
Quantifiable outcome
- 85% of patients achieved clinically meaningful benefit (3+ point rVCSS improvement) at 12 months follow-up in SAVVE trial
- +4 more outcomes
Companies that use enVVeno Medical Corporation
Customer profileSegments2 records
Ideal customer profiles2 records
enVVeno Medical Corporation technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
enVVeno Medical Corporation partnerships and signals
Strategic signalScale indicators10 records
Recent moves7 records
Expansion highlights5 records
enVVeno Medical Corporation competitors and assessment
Company assessmentMarket position
Competitive moat3 records
Key risks6 records
Key highlights6 records
Customer concentration
enVVeno Medical Corporation social profiles
Digital presenceenVVeno Medical Corporation financial estimates
Financial estimateRevenue estimate
Valuation estimate
enVVeno Medical Corporation leadership team
Management profileNumber of profiles
Profiles7 records
enVVeno Medical Corporation funding detail
Funding detailFunding overview
Funding rounds5 records
Investors5 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
enVVeno Medical Corporation M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about enVVeno Medical Corporation
What does enVVeno Medical Corporation do?
enVVeno Medical develops bioprosthetic (tissue-based) replacement venous valves for the treatment of Chronic Venous Insufficiency (CVI) caused by incompetent valves in the deep veins of the leg. Its two investigational products are the VenoValve, a first-in-class surgical replacement venous valve currently evaluated in the SAVVE U.S. pivotal study, and the enVVe System, a next-generation non-surgical, transcatheter-based replacement venous valve with FDA IDE approval for the TAVVE pivotal study. Both are designed as one-way valves to propel blood from the leg back to the heart and lungs.
Is enVVeno Medical Corporation a public or private company?
enVVeno Medical Corporation is a public company. It is classified as public and is currently operating.
When was enVVeno Medical Corporation founded?
enVVeno Medical Corporation was founded in 1999. It employs 11 to 50 people.
Where is enVVeno Medical Corporation based?
enVVeno Medical Corporation is headquartered in Irvine, United States, in the North America region.
How does enVVeno Medical Corporation make money?
One revenue line is on record: medical Device Commercialization (Future).
Does enVVeno Medical Corporation have an API?
No public API is recorded for enVVeno Medical Corporation.
What industry is enVVeno Medical Corporation in?
enVVeno Medical Corporation's product category is Cardiovascular Medical Devices. Its primary akta.pro industry code is HLAHAFAB, Structural Heart Valves (TAVR/SAVR) & Valve Repair, with a secondary code of HLAHAFAJ, Thrombectomy, Embolic Protection & Stroke Intervention Devices. Its NAICS code is 339112 and its SIC code is 3841.