Novostia Turned an EIC Accelerator Grant Into a Heart Valve Trial

Every mechanical heart valve on the market forces its owner to take blood thinners for life, and every tissue valve wears out. Novostia, a start-up incorporated in Neuchâtel in 2017, says its TRIFLO valve avoids both problems: a three-leaflet valve made of a high-performance polymer, designed to last a lifetime without causing blood clots. In the EIC Accelerator pilot's October 2019 cut-off, the European Commission selected it for a grant-only award, according to the official list of winners, which names Novostia as the project's only company. It was one of 75 projects chosen from 1,852 proposals in that round.

CORDIS lists an EU contribution of €2,493,785 towards a total cost of €3,562,550, for a project that ran from 1 April 2020 to 31 July 2023. CORDIS defines that contribution as money "from the EU budget", and Novostia's website credits the EU's Horizon 2020 programme under grant agreement 947344. The grant paid for the work up to the first human implant. The implants themselves came after the project ended.

A Company Still on the Register, Quiet in Public

Novostia SA is an existing company with its seat in Epalinges, according to the Swiss federal register Zefix, and Moneyhouse lists it as active with a share capital of CHF 388,450. Neither shows any insolvency or liquidation. The latest entry in the Swiss Official Gazette of Commerce (SHAB/FOSC), published on 14 November 2025, gave a board member sole signing rights. Neither source shows accounts, revenue, losses or staff numbers.

The company's own news page ends in December 2024, with an ISO 13485 certificate for its quality management system. The trial registry was last updated in August 2025 and lists the study as active, not recruiting. That leaves Novostia a registered company whose current activity cannot be confirmed, with no public sign of the larger trials it said it needed next.

The Technology: A Mechanical Valve That Behaves Like a Natural One

More than 500,000 patients receive a replacement heart valve every year, according to the CORDIS objective. Patients under 65 face a choice. Mechanical valves, usually with two tilting leaflets, last for decades but trigger clots, so patients take anticoagulants for life. Tissue valves made from animal tissue need no such drugs but wear out, on average after about 10 years, CORDIS says. TRIFLO has three leaflets instead of two, which Novostia says gives a blood flow closer to that of a natural valve, and it is made of PEEK, a durable polymer, according to the final project report. The report also claims a lower "acoustic signature", meaning less of the clicking that mechanical valves make.

The design is older than the company. The only patent CORDIS lists for the project, "Mechanical prosthetic heart valve", carries a date of 30 April 2008, nine years before Novostia was registered, according to the CORDIS results page. CORDIS describes the technology as the product of a collaboration between a cardiovascular surgeon and an aerospace engineer.

The strongest independent evidence comes from animals. In a study in 28 sheep published in August 2023 in Interdisciplinary CardioVascular and Thoracic Surgery, 21 animals received TRIFLO and 7 the established On-X bileaflet valve, with no anticoagulation after surgery. The authors reported clean valve surfaces, no thrombo-embolic damage in the organs and lower closing noise for TRIFLO. Novostia supplied the TRIFLO valves, and one author disclosed consulting work and research grants from the company. Before its 2019 funding round, Novostia said it had performed "more than 100 successful long-term (up to 1.5 years) anticoagulant-free animal implants", according to Startupticker.

What the EIC Grant Promised, and What CORDIS Shows

The CORDIS objective set a clear sequence. The EIC grant, combined with €6.5 million raised from private investors in 2018, would "finalize activities necessary to complete first clinical trials, a major step towards CE Marking and commercialization". After that, Novostia would "target a licensing agreement with a global medical device company", or sell through regional distributors.

The final periodic report, covering April 2022 to July 2023, says the preclinical work was finished. All tests required before a first-in-human study were completed and documented, and a "statistically capable" and scalable manufacturing process was validated with Swiss and French manufacturers. Several hundred valves had been made for testing and trials. The Lithuanian authorities approved the clinical protocol in August 2023, the report says, and the first patient was expected in December 2023, after the project's end date. The report also floats three exit routes: licensing or distribution deals, a sale of all or part of the business to an established valve maker, or going it alone.

1. Preclinical verification and validationDeliveredCompleted and documented, per the CORDIS report; animal data published in 2023.
2. Scalable manufacturing processDeliveredValidated, with several hundred units built, per CORDIS.
3. First clinical trialPartly deliveredTen patients implanted after the project ended; no results published.
4. Step towards CE markingNot achievedNo pilot or pivotal study announced; the valve is not approved for sale.
5. Licensing deal with a global device makerNot achievedNo partner announced by the company or anyone else.

The sources disagree on some of the private money. CORDIS says €6.5 million was raised in 2018, while the company's announcement, carried by BioSpace on 22 February 2019, gives CHF 6.5 million. The final CORDIS report says a further €2.5 million came in 2021, while Novostia's own press release dated 1 May 2023 says a Series A of 2.5 million euros "has just been closed".

The Trial: Ten Patients in Vilnius

The first-in-human study, PILATUS, enrolled ten patients needing an aortic valve replacement at Vilnius University Hospital Santaros Klinikos, according to the trial registry, which lists Novostia as sponsor and Veranex as collaborator. The first implant was performed in December 2023 by Prof. Kęstutis Ručinskas, according to GGBa, and all ten operations took place between December 2023 and May 2024, according to Biopôle and the company's news page. Patients were reducing their anticoagulation, with a planned stop in September 2024 and an 18-month follow-up without it, Biopôle reported. Switzerland Innovation also reported that patients were expected to stop by September 2024. Whether they did is not public.

The registry gives December 2025 as the estimated primary completion date, with the primary outcomes measured at 12 and 18 months, and June 2029 for the end of the five-year follow-up. In February 2026 a commentary for the Spanish society of cardiovascular surgery SECCE noted that the data "remain preliminary" and that no detailed results had been published in peer-reviewed journals, including on gradients, valve thrombosis, embolic events or durability. No such paper could be found for this article.

The Money: Bridges, Not the Series B

In its May 2023 release Novostia said a Series B would open "this summer" to fund a pilot study of about 60 patients and a pivotal study of about 500, the studies needed for a CE mark and US pre-market approval. It said the Series B would come in two tranches of 10 and 30 million. No Series B has been announced since. What came instead was a CHF 5.6 million raise in 2024, which the company's press release of 9 September 2024 headed "Bridge to Series B". The same release named Soad El Ghazouani, former co-founder and chief executive of T-Heart, as chief executive, succeeding Alain Barbal, who joined the board. Startupticker reported the same figures. No investor has been named.

The register shows how the money arrived. A capital increase registered in January 2024 totalled CHF 5,289,000, in cash and by converting claims, and another in March 2025 converted CHF 4,600,000 of claims into 7,664 new shares, according to the SHAB entries in Zefix. Who held those claims is not public.

Why Europe Should Care

Cardiovascular disease kills 1.7 million people in the EU every year, and on 16 December 2025 the Commission published its first Safe Hearts Plan to tackle it. The plan focuses on prevention and early detection, but the World Heart Federation notes that it also promotes "better access to innovative treatments and medical technologies". A durable valve that frees younger patients from lifelong blood thinners would be such a technology. The question that matters for Europe is whether the evidence for it will be produced, and at what pace, by a small company financed by bridge rounds.

The Verdict

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