Xeltis Shares Positive Clinical Data From aXess EU Study

Xeltis is reporting encouraging clinical data from the aXess EU pivotal trial that demonstrates the transformative potential of aXess in hemodialysis treatment.

The aXess EU pivotal trial is a prospective study investigating the patency, safety, and performance of aXess, the company’s 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 in 18 European Union sites.

“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,” 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.”

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 and high infection resistance compared to fistulas. Many of the patients in the trial had a history of failed AVG’s 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.

“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 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.”

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 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 excellent 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 and 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 in 2026.

Xeltis is a medtech company developing implants that enable the natural creation of living and long-lasting vessels. Xeltis seeks to address the limitations of currently available options for people requiring hemodialysis access grafts or cardiovascular replacements. The company’s proprietary endogenous tissue restoration (ETR) platform uses an advanced polymer implant that regenerates the patient’s own tissue before gradually being absorbed and leaving new, living, and long-lasting vessels in place. Xeltis’ most advanced product currently under clinical development is aXess, an implantable blood vessel for hemodialysis vascular access. Xeltis’ technology can potentially be applied to other major vascular and cardiovascular diseases.  

Xeltis is based in The Netherlands and the United States. Its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, Ysios Capital, Grand Pharma Group, the European Innovation Council and Invest-NL, in addition to other public and private investors.

*Exploratory analysis — single-arm study evaluated against Objective Performance Criteria; the study was not designed or powered to demonstrate statistical superiority.