Vivalyx's EIC Accelerator Replaces Blood in Donor Organs

The best way to keep a donor organ alive is to perfuse it at body temperature, which also allows doctors to assess and even revive it before transplanting. The catch is that normothermic machine perfusion runs on donated blood, which is scarce, costly and complex to handle. Vivalyx, founded in Aachen in 2022 out of RWTH Aachen and its university hospital, has developed Omnisol, a patented, fully synthetic, blood-free perfusion solution meant to work for all organs and across cold storage, hypothermic oxygenated perfusion and normothermic perfusion.

The EIC Accelerator selected the company at its October 2024 cut-off for blended finance, and CORDIS records a grant of €2,484,382 from August 2025 to July 2027 to take the technology through clinical stage to market. The project cites more than 150,000 people on transplant waiting lists in Europe and the US, with transplants covering under 20% of the need, and claims Omnisol outperforms blood threefold on organ viability and could expand the usable organ pool three to fourfold.

Twenty years of organ preservation research

The founding team is unusually senior for a 2022 start-up: CTO Benedict Doorschodt has built organ preservation devices for more than 20 years, chief medical officer René Tolba is a department director at the Aachen university clinic with a comparable record in the field, chief scientific officer Christian Bleilevens works on extracorporeal organ support, and CEO Andreas Schumacher is a former BCG consultant and head of RWTH's entrepreneurship centre. Malte Brettel, a vice rector of RWTH Aachen, and the medtech founder Marius Rosenberg complete the group.

In April 2024 the company closed an oversubscribed seed round of €5.4 million led by TechVision Fonds and Brightlands Venture Partners, as Startbase reported, to fund the clinical trials needed for approval.

What the preclinical record shows

Omnisol is the optimised formulation of an earlier solution, Ecosol, and the published evidence Vivalyx cites is animal work. In a rat liver transplantation model, Ecosol produced no biliary complications against 57% with the standard UW solution. In porcine kidneys damaged by 45 minutes of warm ischaemia, renal function after cold storage or hypothermic oxygenated perfusion in Ecosol was comparable to undamaged controls preserved in HTK. For normothermic perfusion, the company cites studies showing better antioxidant capacity, function and oxygenation than a red blood cell perfusate over six hours, published in Antioxidants in 2023 and presented at a transplantation congress.

The threefold figures in the EIC project summary are not backed by data on the CORDIS page, and the company's own site is careful: Omnisol is described as preclinically superior "in many dimensions", with its wider intended uses listed as aspirations after future step-wise registrations.

Into the clinic, and the EMA's new pilot

On 16 March 2026 Vivalyx announced that the first patients had received donated kidneys machine-perfused with Omnisol, in a trial at Erasmus Medical Center in Rotterdam comparing it with the solution that has been standard of care for kidney machine perfusion for decades. CTO Doorschodt called it the company's transition from preclinical to clinical stage. Principal investigator Robert Minnee said the team was "genuinely encouraged by the initial observations", but no results have been published.

On 25 August 2026 the EMA granted Omnisol Breakthrough Medical Devices Status, one of five devices selected in a pilot programme launched that April, which gives priority scientific advice from the EU's medical device expert panels. Vivalyx is separately going through conformity assessment with BSI as its notified body. Omnisol remains investigational: no CE mark, no FDA approval, not commercially available.

1. Blood-free perfusate in humansDoneFirst kidneys transplanted in March 2026.
2. Regulatory path in the EUIn progressEMA breakthrough status; conformity assessment with BSI.
3. Clinical results against standard of careNot publishedTrial ongoing at Erasmus MC.
4. Market approval and launchNot yetNo CE mark; product not commercially available.

Equity promised, equity unconfirmed

The EIC award was announced in February 2025 as €2.5 million of grant plus a pre-commitment for a further €6 million of equity, the largest single sum in the company's public funding history. Whether that equity has been invested is not public, and no new round has been announced since the 2024 seed. The grant is also paying for a bigger clinical and commercial team, and the company flags a second use for Omnisol: autotransplantation, where an organ is removed, perfused and treated, then put back into the same patient, with possible applications in cancer surgery. Vivalyx's German accounts were not obtained for this article.

A European answer to an organ shortage

Organ shortage is the kind of problem the EIC likes to fund: a hard medical constraint where a single European product could change practice across health systems. Omnisol's appeal is partly logistical, since replacing blood removes a dependency on donations and simplifies perfusion for hospitals. Both EU instruments involved, the EIC grant and the EMA's new breakthrough pilot, exist to shorten the path from a university laboratory to a certified device, and Vivalyx is now an early test of whether that path works.