Xeltis has announced clinical data from the aXess EU pivotal trial the prospective study investigating the patency, safety, and performance of its restorative vascular access conduit— aXess—in adult patients with end-stage renal disease requiring vascular access to start or maintain haemodialysis therapy.
The results from the trial, which was conducted in 18 centres across Europe, showed that aXess delivered improvements on all key clinical metrics compared to the standard of care, Xeltis has said in a press release.
aXess demonstrated superior sustained patency across both primary and secondary outcomes, compared to other arteriovenous grafts (AVG), while requiring fewer interventions, also showing a lower re-intervention rate compared to standard of care and high infection resistance compared to grafts.
Many of the patients in the trial had a history of failed AVGs or fistulas for dialysis or had previously relied on Central Venous Catheters (CVC), which further underscores the significance of the results, despite the patients’ serious health challenges, the company press release states.
Eliane Schutte, chief executive officer, Xeltis, said: “These results signify a resounding validation of our supreme confidence that aXess represents the future of haemodialysis 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, Xeltis, 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 (AZ Sint-Jan, Brugge, Belgium), coordinating investigator of the aXess EU pivotal trial, commented: “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 (ETR) platform technology, aXess is gradually replaced over time by patients’ own living tissue, dissolving completely over the course of the process.
With only one cannulation-infection related (partial) explant across the full 120 patient population, aXess is also highly infection resistant, and can deliver near-immediate cannulation, with a below 0.02% rate of bleeding complications observed across over 15,000 dialysis sessions.
A US pivotal trial is also taking place for aXess, with patient recruitment well underway and interim results expected in 2026.
