Coronary bypass surgery, Xeltis notes, typically involves harvesting multiple vein grafts, which is painful and carries a high risk of complications. The Eindhoven company makes grafts from materials it calls Restorex, which it says "trigger the body's natural healing response", transforming into living tissue, a process it calls endogenous tissue restoration.
The European Innovation Council granted €2,481,701 towards a €4.21 million project, HeartRestore, to test its coronary artery bypass graft, XABG, in patients, and the EIC Fund invested €12.5 million in 2023. The project enrolled 15 patients; the first three in the EU saw their grafts block within 30 days before fixes were tested. XABG is not yet approved. Xeltis's first product to reach the market is a different graft, aXess for dialysis access, which received a CE mark in April 2026.
Company file
- Legal entity
- Xeltis BV, Eindhoven, Netherlands
- CEO
- Eliane Schutte
- Platform
- Endogenous tissue restoration with Restorex polymers
- Products
- aXess (dialysis, CE marked); XABG (bypass, in trials); pulmonary valve conduit
- US status
- aXess: FDA Breakthrough Device; US pivotal trial over half enrolled
- Investors
- EIC Fund, EIB, Grand Pharma, others
- EIC project
- HeartRestore, 1 Dec 2022 to 30 Nov 2025
- EIC funding
- Blended finance
Where Xeltis Stands Today
With the aXess CE mark, granted "in just 84 working days from submission" according to the company, Xeltis moved from a clinical-stage to a commercial-stage company in Europe. In July 2026 it reported more than 50% enrolment in the US pivotal trial of aXess and announced another €20.5 million of funding to advance it toward FDA approval and a US launch, according to its news page. Its site also lists financing of nearly €50 million from the European Investment Bank and existing shareholders. The dialysis provider DaVita welcomed the CE mark.
The Technology: A Graft That Becomes a Vessel
For bypass surgery, the company says there are no approved off-the-shelf small-diameter grafts with good patency. In July 2025 it reported positive early safety and patency data for XABG in the EU trial, and patency with "excellent flow" at 24 months in an earlier trial.
"Receiving CE mark approval for aXess is a defining moment for Xeltis and a strong validation of our revolutionary restorative technology platform."
Eliane Schutte, CEO, Xeltis, April 2026What the EIC Project Promised, and What CORDIS Shows
HeartRestore promised "next-generation heart bypass grafts to naturally restore cardiovascular function". The CORDIS report is candid: the "initial 3 EU patients experienced graft occlusion at 30 days", and a seven-patient trial in Paraguay was run to validate fixes, including a shorter device, an external sealant and a heparin coating. It reports that Xeltis became "the first company in the world to show patent CABG conduit at 6-months of follow-up", that Germany's BfArM approved trial expansion, and that CE marking remains the target.
- First-in-human bypass trialsDelivered15 patients enrolled.
- A durable open graftPartialEarly occlusions; later patent grafts.
- CE mark for XABGNot yetStill the target.
- Company reaches marketDeliveredaXess CE mark, 2026.
What Has Happened Since the Award
The Money
Xeltis announced €15 million from the EIC Accelerator, and in October 2023 the EIC Fund invested €12.5 million in the final close of its D2 round. It has also raised money from the European Investment Bank, Grand Pharma and existing investors. Its revenue is not public.
What cannot be checked
How many XABG patients now have open grafts and for how long, aXess sales since the CE mark, and Xeltis's total funding and finances are not public in the sources we used.
Why Europe Should Care
An off-the-shelf graft that turns into living vessel would offer an alternative to harvested veins in bypass surgery and to existing dialysis access grafts. The EU has backed Xeltis through the EIC grant, the EIC Fund and the EIB. The EIC-funded bypass graft has had a harder path than expected; the company's commercial breakthrough came with its dialysis product.
What the project promised
Next-generation bypass grafts that naturally restore cardiovascular function.
What the record shows
A 15-patient bypass programme with early failures and later successes, and a CE-marked dialysis graft.
The Verdict
The company advanced, the bypass graft lags
HeartRestore produced honest, mixed results for the coronary graft, which is still far from approval. Xeltis as a whole, with EU equity behind it, has reached the market with aXess. For the EIC, the investment looks promising; the specific project it funded has not yet delivered its product.
Xeltis has not been asked for comment for this article. It is based entirely on company statements and EU project data, linked throughout.
