Xeltis Raises €20.5M to Bring Living Vascular Access Solution to U.S.

Xeltis has raised an additional €20.5 million of new funding from participating investors 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.

This capital builds on the €50 million secured last year from the European Investment Bank (EIB) and existing shareholders. Xeltis said the financing strengthens its ability to advance clinical, regulatory and commercial initiatives.

The proceeds will be used to finalize the ongoing U.S. pivotal trial of aXess, a living vascular access solution for hemodialysis, as well as prepare for U.S. Food & Drug Administration (FDA) submission and U.S. go-to-market. The funding will also power European commercial launch of aXess, upscaling of manufacturing capabilities, and advancement of the company’s XABG and XPAD programs in the clinic.

The financing follows aXess’ European launch and first commercial patient treatment in Germany. Xeltis’ U.S. pivotal trial enrollment has now exceeded 50%, and the device was awarded FDA breakthrough designation in 2024.

The Eindhoven, Netherlands-based company develops implants that enable the natural creation of living, durable vessels for hemodialysis access and cardiovascular applications. Its Restorex platform uses a polymer implant that transforms into the patient’s own tissue before being absorbed, leaving new vessels in place.

Comments from Xeltis and investors

Eliane Schutte, CEO, Xeltis: This fundraising not only enables us to bring our groundbreaking vascular access technology to more European patients, as we continue our successful commercial rollout, but also enables us to advance our aXess pivotal trial in the US, prepare for US market launch and continue our other exciting clinical programs, XABG and XPAD. We welcome our new investor Horizon 3 Healthcare and thank them, and our existing investors, for their confidence in Xeltis as we look to bring much-needed alternatives to patients.”

Matt McNamara, chief investment officer, Horizon 3 Healthcare: “The data generated by Xeltis to date has been highly compelling and underscores the potential of aXess to transform the hemodialysis access landscape and improve patient outcomes. We are impressed by the company’s strong execution and rapid progress and are proud to support Xeltis as it advances aXess through U.S. clinical development and European commercialization, while continuing to expand its broader pipeline of transformative implants.”

Ineke Cazander, investment principal, Invest NL: “Our continued investment in Xeltis reflects the strong progress the company has made in transformative vascular technology. The commercial launch of aXess in Europe marks an important milestone, and we are pleased to support the company’s next phase of commercial expansion and clinical development.”

Hermann Hauser, board member, European Innovation Council (EIC) Fund: “Today’s vascular implants rely on permanent synthetic or biological replacements. Xeltis is pioneering a different approach: enabling implants to gradually transform into the patient’s own living tissue. This shift illustrates how transformative technology is opening new possibilities for patients while reinforcing Europe’s leadership in breakthrough medical innovations. The European Innovation Council is proud to back companies turning this vision into clinical reality.”