When the heart's tricuspid valve leaks, blood flows backwards towards the veins with every heartbeat. Many patients cannot have surgery, and repairing or replacing the valve through a catheter depends on its anatomy. Innoventric, an Israeli company founded in 2017, avoids the valve altogether. Its Trillium device is a stent graft with valves in its wall that runs through the right atrium from the superior to the inferior vena cava, anchored in the two veins rather than in the moving heart.
The European Innovation Council granted €2.5 million towards a €5.53 million project, and it joined the company's $28.5 million Series B in 2024. During the project Trillium went through a European first-in-human study and a US early feasibility study, and more than 40 patients were treated. What it does not yet have is the pivotal trial that approval requires.
Company file
- Legal entity
- Innoventric Ltd, Israel
- Founded
- 2017, Ness Ziona
- Founder and CEO
- Amir Danino
- Product
- Trillium heterotopic cross-caval tricuspid valve (investigational)
- Investors
- RA Capital Management (lead), EIC, BRM Group, JG Private Equity, Mivtach Shamir
- Trials
- First-in-human, 20 patients; US early feasibility, 15 patients
- EIC project
- Trillium, 1 Jun 2022 to 31 May 2026, closed
- EIC funding
- Blended finance (grant and equity)
Where Innoventric Stands Today
According to the company, the US early feasibility study enrolled its 15 patients across eight US and German centres in under a year, by September 2025, and was then extended to include more patients. The first US patient was treated in September 2024 at TriStar Centennial Medical Center in Nashville. ClinicalTrials.gov lists the study as started in August 2024 with follow-up to 2030.
The CORDIS report says the next step is a pivotal study in Europe and the US. We found no announcement that it has started.
The Technology: Around the Valve, Not Through It
Most transcatheter tricuspid devices clip, repair or replace the native valve, which requires suitable anatomy and good imaging. Trillium sits in the veins instead: blood returning to the heart passes through valves in the graft wall, so backflow from the leaking tricuspid valve is kept out of the veins. The CORDIS summary says the procedure takes less than ten minutes without echocardiography guidance or general anaesthesia, and targets patients ineligible for on-valve treatments, which it puts at more than 40% for challenging anatomy alone.
"To revolutionize tricuspid regurgitation care with minimally invasive therapies that significantly improve patient outcomes."
Amir Danino, CEO, Innoventric, on the Series B, via Globes, October 2024What the EIC Project Promised, and What CORDIS Shows
The EIC project, which ran from June 2022 to May 2026, was to finish Trillium's clinical validation. CORDIS reports that 160 devices were produced for verification, animal and biocompatibility testing and other validation; that the 20-patient first-in-human enrolment was completed in June 2023, by which time 34 patients had received the device; that sterilisation and production tests were passed; and that the FDA approved the US feasibility study.
- First-in-human studyDelivered20 patients in Israel, Germany, Belgium and Spain.
- US feasibility studyDelivered15 patients enrolled by September 2025.
- Manufacturing readinessDeliveredSterilisation, LAL and bioburden validated.
- Pivotal trial and approvalNot yetPlanned; no start announced.
What Has Happened Since the Award
The Money
In October 2024 Innoventric raised a $28.5 million Series B led by RA Capital Management, with new investment from the EIC and returning investors BRM Group, JG Private Equity and Mivtach Shamir Holdings, according to Globes and HIT Consultant. That brought total funding to $41 million. The EIC's share was not disclosed.
What cannot be checked
The feasibility study's detailed results, the size of the EIC's investment and when the pivotal trial will begin are not public.
Why Europe Should Care
The project's first-in-human study ran in Germany, Belgium and Spain as well as Israel, and German centres took part in the US-led feasibility study. Patients with tricuspid regurgitation who are unsuitable for existing devices are the group Trillium targets, and European centres have been among the first to use it.
What the project promised
Finished clinical validation of a transcatheter valve for tricuspid regurgitation.
What the record shows
Two feasibility studies, 40+ patients and a $28.5M round with EIC equity; the pivotal trial and approval are still ahead.
The Verdict
On schedule for a medtech, not yet at the finish
Innoventric used the EIC project as intended: two feasibility studies, validated manufacturing and a large private round in which the EIC itself invested. That is steady progress for a structural heart device. The decisive evidence, a pivotal trial, has not started, and until it does no patient outside a study can receive Trillium.
Innoventric has not been asked for comment for this article. It is based entirely on public records, company statements, clinical registry data and EU project data, linked throughout.
