Xeltis Raises an Additional €20.5M of Funding to Advance aXess™ Toward FDA Approval and US Commercial Launch

Xeltis, addressing major life-threatening diseases, backed by Nobel-winning science, led by Eliane Schutte and the team, has raised an additional €20.5M of new funding from new and existing shareholders. Participating investors included the European Innovation Council, Invest-NL, VI Partners, EQT Life Sciences, DaVita and other current shareholders, alongside Horizon 3 Healthcare, a new investor who led the round.

The additional financing, alongside the €50 million secured in 2025 from the European Investment Bank and existing shareholders, reinforces investor confidence in Xeltis' strategy and growth plans. The funding will support completion of the U.S. pivotal trial for aXess™, preparation for FDA submission and commercial launch in the U.S., expansion of the product's rollout across Europe, scaling of manufacturing capabilities, and continued clinical development of the company's XABG and XPAD programs.

Xeltis says the new funding will accelerate the commercialization of its regenerative vascular technologies, supporting the European rollout of aXess™, completion of its U.S. pivotal trial and market launch preparations, and continued clinical development of its XABG and XPAD programs. The company believes the investment reflects strong confidence in its mission to bring new treatment options to patients with vascular disease.

Investors believe Xeltis has demonstrated strong clinical progress with aXess™, highlighting its potential to improve vascular access for hemodialysis patients. The new investment will support the product's U.S. clinical development and European commercialization while advancing the company's broader portfolio of regenerative vascular implants.

Existing investors say Xeltis has made significant progress in advancing its regenerative vascular technology. They view the European commercial launch of aXess™ as a key milestone and believe the new funding will help accelerate the company's commercial expansion and ongoing clinical development.

Investors believe Xeltis is pioneering a new generation of vascular implants that are designed to gradually transform into a patient's own living tissue, offering an alternative to permanent synthetic or biological implants. They see the company's technology as an example of Europe's strength in breakthrough medical innovation and its potential to improve long-term patient outcomes.

The funding follows Xeltis' recent European commercial launch of aXess™, including treatment of its first commercial patient in Germany. At the same time, the company continues to advance its U.S. pivotal trial, which has now enrolled more than half of its target participants, marking continued progress toward regulatory approval and commercialization in the United States.

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