Xeltis Prepares for Commercialization Following Positive aXess EU Trial Data

Xeltis is sharing encouraging clinical data from the aXess EU pivotal trial that indicate the potential of its restorative conduit in hemodialysis treatment.

“First, 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,” Xeltis Chief Medical Officer Paulo Neves said. “These results are transformative for us as a company, and we look forward to continuing this momentum as we develop our commercial strategy.”

The aXess EU pivotal trial is a prospective study investigating the patency, safety, and performance of aXess, Xeltis’ restorative vascular access conduit, in adult patients with end-stage renal disease requiring vascular access to start or maintain hemodialysis therapy. The study is being conducted at 18 EU sites.

Trial results showed that aXess delivered major improvements on all key clinical metrics compared to the standard of care. 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 trial patients had a history of failed AVG’s or fistulas for dialysis or had previously relied on central venous catheters (CVC), which further underscores the results’ significance despite the patients’ serious health challenges.

“These results signify a resounding validation of our supreme confidence that aXess represents the future of hemodialysis vascular access treatment,” Xeltis CEO Eliane Schutte stated. “After this clear demonstration of its excellence on all clinical fronts, not to mention the polymer technology is 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.”

Developed through Xeltis’ proprietary Endogenous Tissue Restoration (ETR) platform technology, which uses Nobel prize-winning breakthroughs in polymer 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 more than 15,000 dialysis sessions. With these results, aXess possesses an unprecedented safety and efficacy profile, and has proved its superiority on all fronts compared to the current standard of care, according to the company.

“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,” commented An De Vriese, coordinating investigator of the aXess EU pivotal trial and head of Nephrology & Infectious Disease, AZ Sint-Jan, Brugge.

A U.S. pivotal trial is also taking place for aXess, with patient recruitment well underway and interim results expected next year.

Xeltis is a medtech company developing vascular implants that enable the natural creation of living and long-lasting tissue.

* Exploratory analysis — single-arm study evaluated against objective performance criteria; the study was not designed or powered to demonstrate statistical superiority.