Xeltis secures additional funding to finalise US pivotal trial of aXess vascular access conduit

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Axess graft

Xeltis has announced an additional €20.5m of new funding from new and existing shareholders, with the proceeds to be used to finalise the ongoing US pivotal trial of its living vascular access solution for haemodialysis, aXess, and prepare for US Food and Drug Administration (FDA) submission and US market preparation.

Participating investors included the European Innovation Council (EIC), Invest-NL, VI Partners, EQT Life Sciences, DaVita and other current shareholders, alongside Horizon 3 Healthcare, a new investor who led the round.

Eliane Schutte, CEO, Xeltis, said: “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 USA, prepare for US market launch and continue our other exciting clinical programmes, 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 of Horizon 3 Healthcare, commented: “The data generated by Xeltis to date has been highly compelling and underscores the potential of aXess to transform the haemodialysis 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 US clinical development and European commercialisation, while continuing to expand its broader pipeline of transformative implants.”

Ineke Cazander, investment principal, Invest NL, added: “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, EIC Fund, said: “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.”

The fundraising follows the recent announcement by Xeltis of the European launch of aXess, with the successful treatment of the first commercial patient in Germany. Alongside European commercialisation, Xeltis continues enrolment in its US pivotal trial of aXess, which now exceeds 50%.

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