Xeltis has announced successful clinical data from its aXess EU pivotal trial, demonstrating strong efficacy and safety in hemodialysis vascular access treatment and positioning the company for commercialization. The trial, conducted across 18 European sites, evaluated the patency, performance, and safety of aXess, Xeltis’ restorative vascular access conduit, in adults with end-stage renal disease requiring dialysis.

The results showed major improvements across all key clinical metrics compared to standard arteriovenous grafts. aXess delivered superior sustained patency for both primary and secondary outcomes, required fewer interventions, and exhibited high infection resistance compared to fistulas. Many trial participants had a history of failed grafts or fistulas or had relied on central venous catheters, highlighting the significance of the outcomes in a patient population with complex medical needs.

Eliane Schutte, chief executive at Xeltis, said: “These results signify a resounding validation of our supreme confidence that aXess represents the future of hemodialysis vascular access treatment. After this clear demonstration of its excellence on all clinical fronts, not to mention being PFAS free, Xeltis is now poised to enter the next stage of its journey as a commercial stage company bringing benefits for patients, providers and payers.”

Paulo Neves, chief medical officer, added: “Firstly, we would like to sincerely thank all the participants in this EU pivotal trial, from our very own scientists, who helped develop the technology, to the clinicians who believed in the potential of our treatment, the dialysis clinics and nurses and finally to the patients who placed their confidence in our product for their treatment. These results are transformative for us as a Company, and we look forward to continuing this momentum as we develop our commercial strategy.”

An De Vriese, coordinating investigator of the trial and head of nephrology & infectious disease at AZ Sint-Jan, Brugge, said: “Xeltis’ technology is truly transformative, delivering superior sustained patency along with fewer interventions and complications, such as infections. This is unprecedented in our industry and heralds a new dawn in sustainable treatment options for patients.”

Developed through Xeltis’ proprietary Endogenous Tissue Restoration platform, aXess gradually integrates into patients’ own living tissue, dissolving completely over time. The trial reported only one cannulation-infection related partial explant across 120 patients and a below 0.02% rate of bleeding complications over more than 15,000 dialysis sessions.

A US pivotal trial is ongoing, with patient recruitment underway and interim results expected in 2026. The strong EU data reinforces aXess’ safety and efficacy profile, supporting Xeltis’ move toward commercialization.