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.

€2.48MEIC grant, 59% of a €4.21M project
€12.5MEIC Fund investment, October 2023
15XABG first-in-human patients enrolled
Apr 2026CE mark for aXess dialysis graft

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 2026

What 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.

  1. First-in-human bypass trialsDelivered15 patients enrolled.
  2. A durable open graftPartialEarly occlusions; later patent grafts.
  3. CE mark for XABGNot yetStill the target.
  4. 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.