Xeltis has announced successful results from its aXess EU phase 3 trial, confirming the potential of its restorative vascular access conduit for patients undergoing hemodialysis. The multicentre study met its primary endpoint and showed major improvements compared to standard of care.
Conducted across 18 EU sites, the trial involved 120 patients with end-stage renal disease. Many had previously experienced failed grafts or fistulas or relied on central venous catheters. aXess demonstrated superior sustained patency, fewer interventions and high infection resistance.
Eliane Schutte, Chief Executive Officer, Xeltis, said: “These results signify a resounding validation of our supreme confidence that aXess represents the future of hemodialysis vascular access treatment.”
Paulo Neves, Chief Medical Officer, Xeltis, added: “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 and Head of Nephrology & Infectious Disease at AZ Sint-Jan, Brugge, commented: “Xeltis’ technology is truly transformative, delivering superior sustained patency along with fewer interventions and complications, such as infections.”
Developed using Xeltis’ Endogenous Tissue Restoration platform, aXess is gradually replaced by the patient’s own tissue and dissolves completely over time. The device is PFAS free and designed to offer near-immediate cannulation.
Across more than 15,000 dialysis sessions, aXess showed a below 0.02% bleeding complication rate and only one cannulation-infection related explant. The safety and efficacy profile is described as unprecedented compared to current options.
A US phase 3 trial is also underway, with patient recruitment progressing and interim results expected in 2026. Xeltis now plans to move forward with commercialisation, aiming to set a new standard in vascular access for dialysis patients.
