enVVeno Medical Corporation

What they do

enVVeno Medical is a medical device company focused on bioprosthetic (tissue-based) solutions for venous disease, specifically developing a replacement venous valve for patients with severe Chronic Venous Insufficiency (CVI) of the deep venous system of the leg. The company's current focus is its next-generation non-surgical enVVe System, which consists of the enVVe Valve, Delivery System, Nose Cone, Delivery System Accessories, and Crimping System. It previously developed the surgical VenoValve, for which it received a not-approvable letter from the FDA in August 2025. The company develops and manufactures its products in a 14,507 sq. ft. leased ISO 13485-2016 certified facility in Irvine, California.

Revenue drivers

• enVVe System (pre-commercial) — The enVVe System is the company's lead product candidate, a non-surgical transcatheter replacement venous valve; it has not generated any revenue and is not yet approved for sale.
• VenoValve (discontinued development) — The VenoValve was a first-in-class surgical replacement venous valve; the FDA issued a not-approvable letter in August 2025, and the company is now focused on enVVe instead.
• No current product revenue — The company has no approved products and has not reported revenue from product sales in any of the recent periods presented.

Recent performance

The company has no approved products and has not reported product revenue in recent years. Annual net losses were $16.5M in 2021, $24.7M in 2022, $23.5M in 2023, $21.8M in 2024, and $19.5M in 2025. Operating cash flow was negative $11.8M in 2021, negative $15.6M in 2022, negative $18.9M in 2023, negative $16.8M in 2024, and negative $15.6M in 2025. As of June 30, 2026, total assets were $22.7M, total liabilities were $2.0M, shareholder equity was $20.7M, and cash and equivalents were $2.8M. The company reported approximately $25 million in cash and investments as of March 31, 2026, which it expects to fund operations into the third quarter of 2027.

Strategy

The company's priority is advancing the enVVe System, its non-surgical transcatheter replacement venous valve, through clinical and regulatory steps. In April 2026, the FDA awarded IDE approval to proceed with the TAVVE U.S. pivotal study. The TAVVE study's first stage is expected to commence in the second half of 2026 with 10 patients, whose 30-day safety results will be submitted to the FDA; the second stage will enroll 220 patients (165 receiving enVVe, 55 randomized to standard of care) at up to 40 U.S. clinical sites. The company would be eligible to file for FDA post-marketing approval one year after the 220th patient is enrolled in the second stage. The company focuses on manufacturing at its Irvine, California facility.

Risks

• No approved products or revenue — The company has no approved products and has not generated product revenue, relying on financing to fund operations.
• Regulatory approval uncertainty — The enVVe System is still in development and may not receive FDA approval; the prior VenoValve PMA received a not-approvable letter in August 2025.
• Clinical trial execution risk — The TAVVE pivotal study must enroll patients and produce safety and efficacy data, with the first stage not expected to commence until the second half of 2026.
• Reliance on third-party suppliers and manufacturing scale-up — The company relies on third-party suppliers for certain components and must scale up manufacturing for its product candidates.

Outlook

Management expects the first stage of the TAVVE pivotal study to commence in the second half of 2026, with 10 patients and 30-day safety results to be submitted to the FDA. The second stage would then enroll 220 patients, and one year after the 220th patient is enrolled, the company would be eligible to file for FDA post-marketing approval. The company reported approximately $25 million in cash and investments as of March 31, 2026, expected to fund operations into the third quarter of 2027.