Xeltis releases groundbreaking new 12-month EU pivotal data for aXess™ demonstrating the transformative potential in hemodialysis treatment

• Data demonstrates strong and higher secondary patency compared to conventional arteriovenous grafts (AVG) to meaningfully transform vascular access
• 79% secondary patency at 12 months in complex patient populations supported by low reintervention burden (1.3 patency‑related reintervention rate per patient year) and a 3% clinically relevant access related infection rate
• CE mark approval enables Xeltis to commercialize aXess™ in Europe
  
  

EINDHOVEN, The Netherlands, April 21, 2026 (GLOBE NEWSWIRE) -- Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, today announced new 12-month clinical data from the aXess multi-center EU pivotal trial, which enrolled 120 patients in 22 clinical trial sites from 9 European countries, demonstrating the transformative potential of aXess™ in hemodialysis treatment.

The 12-month pivotal data demonstrate strong and higher secondary patency of aXess™ compared to conventional arteriovenous grafts (AVG), requiring fewer interventions, lower re-intervention rate compared to standard of care and high infection resistance compared to grafts.

The aXess pivotal study enrolled a real-world patient population, in which most (69%) of the patients had previously used a central venous catheter (CVC) and had a failed fistula. Findings demonstrated strong durability outcomes, including 79% secondary patency and a very low patency‑related reintervention rate of 1.3 per patient year, alongside a substantial reduction in infection burden. Compared with alternative access options using published benchmark data, patency‑related reinterventions were 60% lower than AVGs and 30% lower than arteriovenous fistulas (AVF), meaning fewer access procedures for patients. At one year, the access‑related infection rate was 3%, versus 22% for CVCs and 9% for AVGs.

These findings build on earlier evidence from the six-month EU pivotal trial results which demonstrated significantly improved clinical outcomes compared with ePTFE AVGs, benchmarked against established objective performance criteria, and reconfirm earlier findings observed across previous studies. Importantly, these outcomes are further reinforced by the durability demonstrated across Xeltis’ broader clinical experience including excellent 24-month first-in-human outcomes from a 20-patient European study, as well as long-term clinical cases with follow-up now exceeding four years, providing compelling evidence of longevity and sustained function over time.

Taken together with the newly available 12-month pivotal trial data, this comprehensive body of evidence underscores both the clinical benefit and long-term durability of the technology. CE mark approval was obtained in record time, enabling Xeltis to commercialize aXess™ in Europe.

Eliane Schutte, Chief Executive Officer, Xeltis, said: “These are tremendous results and represent the first large-scale clinical dataset of its kind generated in Europe. The data demonstrate that aXess™ is safe and easy to implant, and by 12 months transforms into a tissue-like, pulsating conduit. With this level of clinical evidence, we can now move forward with the commercialization of aXess™ and begin delivering it to patients in real-world clinical practice. Patients deserve better options, and this technology has the potential to transform outcomes and save lives.”

Dr. Augusto Ministro, Professor of Vascular Surgery at ULS Santa Maria, Portugal, commented: “The combination of a reduced intervention burden, strong infection resistance, early cannulation capability, and a short time to hemostasis represents a significant advance for patients and clinicians alike. These attributes address many of the persistent challenges associated with conventional vascular access, making aXess™ a highly compelling option for improving durability, usability, and overall patient outcomes.”

Dr. An De Vriese, Head of the Dept of Internal Medicine and Division of Nephrology and Infectious Disease at AZ Sint-Jan Brugge, Belgium, and co-Principal Investigator of the study, commented: “The 2 pillars of aXess™ are reduced interventions and low intervention rates. The short time to hemostasis is very important for improving the quality of life of the patient.”

Dr. Peter Schneider, Professor of Surgery in the Division of Vascular & Endovascular Surgery at University of California, San Francisco, US, added: “Having endothelium along the entire lumen of what started out as a prosthetic graft is a holy grail in our field that many have tried to achieve. It looks like now we finally have it.”

Built on Nobel Prize-winning science, aXess™ leverages Restorex™ breakthrough polymer technology, transforming into the patient’s own tissue, forming a living vessel for sustained vascular access and reducing intervention burden and catheter dependency.

The Xeltis team presented these data at The 48th Charing Cross Symposium, London, UK, from 21-23 April 2026.

Contacts

Xeltis
Eliane Schutte, CEO
Alexander Goemans, CFO
info@xeltis.com

Optimum Strategic Communications
Nick Bastin, Eleanor Cooper, Aoife Minihan
+44 (0) 208 078 4357
xeltis@optimumcomms.com  

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 Restorex™ 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 commercial 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/

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