Xeltis’ aXess EU key trial shows sustained patency, fewer interventions, and high infection resistance, reinforcing its potential for hemodialysis patients

Xeltis has reported strong clinical data from its aXess EU key trial, highlighting the transformative potential of its restorative vascular access conduit for patients undergoing hemodialysis. The trial showed that aXess met its primary endpoint with standout sustained patency rates, outperforming the standard of care across multiple measures.

The EU key study enrolled 120 adult patients across 18 sites, focusing on the patency, safety, and performance of aXess in those requiring vascular access to start or maintain hemodialysis. Many participants had previously experienced failed arteriovenous grafts (AVGs), fistulas, or relied on central venous catheters, underscoring the significance of the results in a high-risk population.

Data from the trial demonstrated superior sustained patency for both primary and secondary outcomes, fewer interventions, lower re-intervention rates, and high infection resistance compared to conventional AVGs. “These results signify a resounding validation of our supreme confidence that aXess represents the future of hemodialysis vascular access treatment,” said Eliane Schutte, chief executive officer of Xeltis. “After this clear demonstration of its excellence on all clinical fronts, 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, highlighted the collaborative effort behind the results: “Firstly, we would like to sincerely thank all the participants in this EU key trial, from our very own scientists, to the clinicians, dialysis clinics and nurses, and finally the patients who placed their confidence in our product. These results are transformative for us as a company, and we look forward to continuing this momentum as we develop our commercial strategy.”

The trial’s coordinating investigator, An De Vriese, head of nephrology & infectious disease at AZ Sint-Jan, Brugge, added: “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 using Xeltis’ proprietary Endogenous Tissue Restoration (ETR) platform, aXess gradually replaces itself with the patient’s own living tissue, dissolving completely over time. The device also demonstrated impressive safety outcomes, with only one cannulation-infection related partial explant among all patients and a bleeding complication rate below 0.02% across more than 15,000 dialysis sessions. Immediate cannulation is possible, and infection resistance is high, reinforcing aXess’ clinical profile compared to the current standard of care.

A US key trial for aXess is ongoing, with patient recruitment progressing and interim results expected in 2026, as Xeltis moves closer to commercialization.