From EIC Accelerator Grant to US Trials: Trisol's Tricuspid Valve

The tricuspid valve, which separates the two right-hand chambers of the heart, gets far less attention than the aortic and mitral valves on the left side, and when it leaks badly most patients are left with diuretics because open-heart surgery is too risky for them. Trisol Medical, a start-up in Yokneam in northern Israel, is building a valve that is pushed into place through a vein instead. In October 2019 the European Commission selected it in the EIC Accelerator pilot cut-off of 9 October 2019 for blended finance, a grant plus EIC equity. The list names Trisol as the only company on the project.

The grant was €2,324,935.20 towards a €3,321,336 project that ran from 1 February 2020 to 31 January 2024, according to CORDIS. Its aim was to validate the device in animals, implant it in the first humans and run "the First-In-Human and CE mark clinical trial". Nearly three years after the project closed, the valve has been implanted in more than 20 patients in an FDA-approved US study and the EIC Fund is a shareholder. No CE mark trial in Europe has been announced, and the valve is not approved anywhere.

Where Trisol Stands Now

Trisol is active. The Israeli Corporations Authority's company register, published as open data on data.gov.il, lists Trisol Medical Ltd, company number 515485944, as an active private company incorporated on 12 July 2016, with its last annual report filed for 2026. OpenCorporates shows the same number, active status and registered address. On 21 January 2026 it announced results from its US Early Feasibility Study, in a release distributed by PR Newswire and carried by BioSpace and Kyodo News PR Wire. Twenty-two patients with severe to torrential tricuspid regurgitation, all at high risk for surgery, had been treated through the jugular vein in the neck at five US centres: Piedmont Heart Institute, Vanderbilt, the University of Virginia, Columbia and Cedars-Sinai. That cohort is closed, and the study is now enrolling patients with a new delivery system that enters through the femoral vein in the groin.

The company reported fewer than 5% of patients needing a permanent pacemaker at 30 days, no device migration, and "considerable" reduction of the leak, with improvements at 30 days and 12 months in quality of life, heart failure class, six-minute walk distance and right ventricular function. The release gives no patient-level numbers, and no peer-reviewed paper on the US cohort could be found. The study registration, NCT04905017, last updated in November 2025, lists it as recruiting with an estimated 30 patients, a primary completion date of January 2026 and seven US sites. No site in Europe or Israel is listed there.

The Technology: One Leaflet Instead of Three

Most transcatheter heart valves copy the natural three-leaflet design. Trisol's uses a single dome-shaped leaflet on a nitinol frame, which, according to the company's August 2023 release, works like two leaflets and is held in place by anchors along the heart's axis to reduce damage to the conduction system, which is why pacemaker rates matter. The company says the design eliminates the leak while preserving the function of the right ventricle, the pumping chamber that often weakens in these patients.

The first human implant was described in JACC: Case Reports in August 2021: a 71-year-old woman at Rabin Medical Center in Petach Tikva, Israel, received the valve through the internal jugular vein and went home on the sixth day with only trace leakage. The lead author, Dr. Mordehay Vaturi, is Trisol's founder and medical director, which the paper discloses. CORDIS lists this case report as the project's only peer-reviewed publication.

The field has moved on since 2019. Edwards Lifesciences' EVOQUE valve received a CE mark in October 2023 and, on 2 February 2024, became the first transcatheter tricuspid replacement approved by the US FDA, according to Cardiac Interventions Today and HCPLive. Trisol now competes as a later entrant and argues that its pacemaker rate and its results in patients with weak right ventricles set it apart. No head-to-head data exist.

What the EIC Project Promised, and What CORDIS Shows

The EIC project followed a €50,000 SME Instrument Phase 1 grant for a four-month feasibility study, from 1 September 2018 to 31 December 2018, according to CORDIS. That plan already set out the Phase 2 goals: scale up production, start clinical trials and obtain the CE mark.

The Phase 2 project's final periodic report, for the period to 31 January 2024, states that Trisol completed verification, validation and animal testing, received ethics committee approvals and implanted the valve in 17 patients with severe to torrential regurgitation. It concludes that implanting the valve is "safe and feasible" and that right ventricular function improved acutely. In its forward-looking section it still describes the goal as clinical trials "in selected hospitals across Europe and Israel" to collect the evidence "required for CE Mark certification and market launch". In other words, the CE mark trial named in the project objective had not been completed when the 48-month project ended.

1. Verification, validation and preclinical studyDeliveredAnimal testing and V&V completed, per the CORDIS report.
2. First-in-human studyDeliveredFirst case published in 2021; 17 patients by January 2024.
3. CE mark clinical trial in EuropeNot achievedNo European trial announced or registered; the clinical programme moved to the US.
4. CE mark and market launchNot achievedNo approval in any market as of October 2026.
5. Production scale-upUnverifiedNo public figures on manufacturing capacity.

On time, the record is mixed. The project closed on its scheduled end date, and the human implants it promised happened. The pivotal trial that Trisol said in August 2023 it would start "in 2024", according to Cardiac Interventions Today and the company's release, had not been announced by October 2026; in January 2026 it was still described as a next phase.

The Money

Trisol's financing is mostly undisclosed. In October 2018 it raised $2.7 million from US, Israeli and Chinese investors, according to Globes, which named Dr. Shimon Eckhouse, founder of Syneron and former chairman of Ventor Technologies, as incubator owner and investor, with support from Clalit Health Services and the Israel Innovation Authority.

The equity part of the EIC award did happen. Trisol is listed as "TRISOL MEDICAL" in the EIC Fund's list of invested companies (page 16 of the list). Neither the Fund nor the company has published the amount or the date. The data aggregator Bouncewatch records EIC venture rounds dated October 2019 and 28 July 2023, both of undisclosed size, and a total of $5.10 million across five rounds, made up of the 2018 seed round and the two EU grants (the Phase 1 grant entered at its €71,429 total cost rather than its €50,000 EU contribution). Search summaries of Dealroom's database give $31.43 million across four rounds; that page could not be opened to check it. Neither total is confirmed by the company, and the gap between them is too large to chart.

Why Europe Should Care

Cardiovascular disease causes one in three deaths in the EU, and on 16 December 2025 the Commission adopted the Safe Hearts Plan, which asks every member state to have a national cardiovascular health plan by 2027 and covers treatment and care as well as prevention, according to the European Society of Cardiology and DAIC. Trisol's own CORDIS report counts 2 million Europeans with moderate to severe tricuspid regurgitation, of whom only a small share are operated on.

The European return the project described, a CE mark trial in European hospitals and a European market launch, has not materialised. The trials, the investigators and the first commercial target are now American. EU money helped carry a device into patients; whether European patients get access first, or at all, depends on decisions Trisol has not announced.

The Verdict

Trisol Medical has not been asked for comment for this article. It is based entirely on public records, company statements and EU project data, linked throughout.