CroíValve's Two EIC Accelerator Awards, One Heart Valve in Trials

CroíValve, a Dublin medical device company spun out of Trinity College Dublin, is developing DUO, a valve delivered by catheter that sits inside a leaking tricuspid valve and works alongside it instead of replacing it. The European Commission's list of companies selected at the 3 April 2019 cut-off of the EIC SME Instrument Phase 2 names CroiValve, alone, for CVTVT, "A Non-Surgical Treatment to Restore Heart Valve Function". CORDIS records an EU contribution of €2,494,970 towards a total cost of €5,450,186.50, from 1 October 2019 to 31 October 2022. The proposal said the grant would "complete clinical trials and demonstrate safety and efficacy for CE Mark approval". Four years after the project ended, CroíValve says in every release, most recently in July 2026, that the device is investigational and "not commercially available in any geography".

The company has not stalled, however. It has run a first-in-human study in Poland, opened a US feasibility study, won a second EIC award, this time a Horizon Europe EIC Accelerator award with blended finance at the 12 March 2025 cut-off, and brought in the EIC Fund and the British investor BGF as shareholders in June 2026, according to its announcement and Pulse 2.0.

Where CroíValve Stands in 2026

CroíValve is active and raising money. On 22 June 2026 it announced a $20 million extension of its Series B, taking the round to $36 million, plus $7 million in grants from the EIC and Ireland's Disruptive Technologies Innovation Fund (DTIF), $43 million in total. BGF and the EIC are new investors and the MedTech Syndicate took part again, according to the company and Pulse 2.0. The money is to enlarge the TANDEM II study beyond the 15 patients treated so far, with more US and European sites.

On 28 July 2026 the board named Jaime Wheeler chief executive. She spent 12 years at Edwards Lifesciences, most recently as senior vice president of global clinical affairs for its transcatheter heart valve business. Co-founder Lucy O'Keeffe, the previous chief executive, became chief operating officer, according to the company's announcement. Both the SoloCheck summary of the Irish company register and OpenCorporates list CroiValve Limited as "Normal", with an annual return made up to 30 September 2025; SoloCheck lists a director change effective 13 July 2026 and two share allotments dated December 2025 and January 2026.

The Technology: A Second Valve Inside the First

In tricuspid regurgitation the valve between the right atrium and right ventricle no longer closes, usually because heart failure has stretched the right heart, and blood leaks backwards. CroíValve's CORDIS project summary says fewer than 1% of patients are treated surgically because open-heart surgery is so risky. The two established catheter approaches are repair, which clips the leaflets together or shrinks the valve ring, and replacement, which swaps the valve for a prosthesis. CroíValve calls DUO a third way: a "valved spacer" placed between the leaflets of the native valve, held by an adjustable anchor in the vein above the heart so that nothing hooks into the heart tissue, according to the CVTVT final report. The first version goes in through a neck vein; the Duo Fast Track to Innovation project developed a version through a leg vein, which the company said could be done under local sedation instead of general anaesthetic.

The bar for a newcomer has risen. In February 2024 Edwards Lifesciences' Evoque became the first transcatheter tricuspid device approved in the United States, after receiving its CE mark in October 2023, according to MedTech Dive and TCTMD, which also notes that Abbott's TriClip repair device already had a CE mark. CroíValve's case, made in its CORDIS report, is that repair and replacement each leave out patients or are hard to perform; whether a coaptation valve does better than either has not been tested head to head.

The Clinical Record So Far

The final CVTVT report, covering the period to 31 October 2022, says the design was finalised and "a first in human study of this device in 5 patients" showed "significant symptomatic improvement". The company announced the first-in-human implants of the TANDEM I study publicly on 18 November 2022, at the National Institute of Cardiology in Warsaw and the Medical University of Silesia in Katowice, according to a release republished by Broadview Ventures.

Six-month results for 10 TANDEM I patients were presented at New York Valves in June 2024: regurgitation fell to moderate or less in more than 85% of patients, per an independent core lab, all patients were alive at six months and none needed a permanent pacemaker, according to Cardiac Interventions Today. The company adds that 100% of patients reached NYHA class I or II and that the six-minute walk distance improved by an average of 63 metres. These are company-reported results from a small single-arm study without a control group; no peer-reviewed publication of the six-month data was found.

The US study followed. The Duo project's final report to November 2023 says the FDA approved an early feasibility study after 107 submitted documents and 42 questions. The first US patient in TANDEM II was treated at Piedmont Heart Institute in Atlanta, as announced on 24 October 2024 by the company and reported by Cardiac Interventions Today. By June 2026 TANDEM II had treated 15 patients, now with a version the company calls DUO Adapt. No TANDEM II results have been published.

What the 2019 Grant Promised, and What It Delivered

The Commission's April 2019 list shows CroiValve as the sole beneficiary of CVTVT, with no partner companies. The CORDIS objective promised the activities needed to "demonstrate safety and efficacy for CE Mark approval", alongside private money to "expand its manufacturing capabilities, build up its sales and marketing infrastructure". The project ran its full 37 months and reported over three periods. It delivered the design, verification testing and the five-patient first study. It did not deliver a CE mark, and no sales organisation has been announced, since the device is not on sale anywhere.

1. Final device design and pre-clinical testingDeliveredDesign finalised and tested, per the CORDIS final report.
2. First-in-human studyDeliveredFive patients in the project; TANDEM I implants announced November 2022.
3. Safety and efficacy data for CE markingPartlySix-month data on 10 patients, company-reported, no control group.
4. CE Mark approvalNot achieved"Not commercially available in any geography", July 2026.
5. Manufacturing, sales and marketing build-upNot achievedNo sales; volume manufacturing only planned in the Duo FTI report.

The 2019 grant did not stand alone. From June 2020 to November 2023 CroíValve coordinated Duo, a Horizon 2020 Fast Track to Innovation project with an EU contribution of €2,969,786, of which €1,898,295 went to CroíValve and the rest to Innovative Catheter Solutions in Galway, Syntactx Europe in Herzele, Belgium, and 3D LaserTec in Yavne, Israel, according to CORDIS. Its final report records the FDA approval to start the US study. CroíValve is also an associated partner, without EU funding, in MEDALLOY, a doctoral network on nitinol for medical devices that started in January 2026.

DUO 4 ALL: The 2025 EIC Accelerator Award

The Commission's list for the March 2025 cut-off names CROIVALVE LIMITED for DUO 4 ALL with blended finance. CroíValve put the package at a €2.5 million grant and a €10 million equity investment tied to its next financing round, in a release reported by Medical Device Developments. Enterprise Ireland and ThinkBusiness reported "up to €18.75m" for CroíValve and the acoustic materials company Lios together, without a split.

CORDIS shows a grant of €2,493,375 for DUO 4 ALL, signed on 24 October 2025 and running from 1 August 2025 to 31 January 2027. Its objective describes a "Tricuspid Coaptation Valve System" that can "accommodate the range of patient anatomies" and is "quick to learn and implant", without dated milestones. The project is still running, so delivery cannot be judged yet. What can be checked is the equity: CroiValve appears on page four of the EIC Fund's list of invested companies, checked on 14 October 2026 across all 16 pages, and the company named the EIC as a new investor in the June 2026 Series B extension. The amount the EIC Fund invested has not been published; the €10 million figure is the 2025 offer, not a confirmed investment.

The Money Behind the Valve

CroíValve has financed itself mainly through Irish business angel syndicates. It raised €3.2 million from angels and then €1.5 million from Broadview Ventures and existing investors in 2019, according to Silicon Republic in September 2019 and its 2024 report. An €8 million Series A followed in 2022, according to EIT and Silicon Republic, and a $16 million Series B led by the MedTech and Irrus Syndicates in August 2024, according to the company and Silicon Republic. SoloCheck lists 25 shareholders, the largest being Medtech Syndicate Nominee Limited.

Ireland's DTIF has also backed the company. An Atlantic Technological University release of October 2025 lists a "CroíValve- DUO MAX Project (€7.1m)" in DTIF Call 7 without saying whether that is the grant or the project value, and Enterprise Ireland confirms earlier DTIF funding without an amount. CroiValve Limited's filed accounts, the latest to 31 December 2024 per SoloCheck, are not free to view, so revenue, losses, equity and staff numbers could not be verified; SoloCheck classes it as a small company.

Why It Matters for Europe

Cardiovascular diseases are the leading cause of death in the EU, killing 1.7 million people a year and costing over €282 billion annually, according to the European Commission, which presented its first plan for the field, the Safe Hearts Plan, on 16 December 2025; the World Heart Federation gives the same death toll. The plan covers treatment and care alongside prevention. The first catheter-based tricuspid devices to reach patients, Evoque and TriClip, came from Edwards Lifesciences and Abbott, as shown above. CroíValve keeps its research, development and operations in Ireland, while its clinical and regulatory teams are in the US, per its announcement.

The Verdict

CroíValve has not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.