Xeltis poised for commercialization following excellent clinical data from aXess EU pivotal multicentre trial

• Complete EU pivotal trial data highlights transformative potential of aXess in hemodialysis treatment 
• Primary endpoint met with standout sustained patency rates, with major improvements demonstrated across the board compared to standard of care
• Enhances clinical profile of aXess, reinforcing excellent first-in-human outcomes amid ongoing US pivotal trial and ahead of commercialization

EINDHOVEN, The Netherlands, Sept. 24, 2025 /PRNewswire/ -- Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, today announces successful clinical data from the aXess EU pivotal trial, demonstrating 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, 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 in 18 sites across the EU.

The results from the trial 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 Catheter's (CVC), which further underscores the significance of the results, despite the patients' serious health challenges.

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. 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, Coordinating Investigator of the aXess EU pivotal trial and Head of Nephrology & Infectious Disease, AZ Sint-Jan, Brugge 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, which utilises 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 over 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.

A US pivotal trial is also taking place for aXess, with patient recruitment well underway and interim results expected in 2026.

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

About Xeltis
Xeltis is a medtech company developing transformative implants that enable the natural creation of living and long-lasting vessels. Xeltis seeks to address the limitations of currently available options for the millions of people requiring hemodialysis access grafts or cardiovascular replacements every year. The Company's proprietary endogenous tissue restoration (ETR) platform utilizes an advanced polymer implant which 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^TM, an implantable blood vessel for hemodialysis vascular access. Xeltis' groundbreaking technology has high potential to be applied to other major vascular and cardiovascular diseases. 

Xeltis is based in The Netherlands and the USA. 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.

Visit the Xeltis website for more details: https://xeltis.com/