Xeltis makes first commercial implant of aXess™, its vascular access device for hemodialysis

• Marks start of European commercial rollout of aXess™, bringing it into routine clinical practice
• Builds on CE mark approval in record time, underpinned by positive EU pivotal trial data
• Introduces a first-of-its-kind living vascular access solution for patients requiring hemodialysis

EINDHOVEN, The Netherlands, July 07, 2026 (GLOBE NEWSWIRE) -- Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announced today the official start of the European commercialization of aXess™, marked by the successful treatment of the first commercial patient by Dr Dominik Liebetrau at Artemed Klinikum Munich South, Germany.

aXess™ represents a new category of vascular access. Implanted in a single procedure and based on Nobel Prize-winning supramolecular science, the medical device initially serves as a scaffold ready for cannulation before gradually transforming into each patient's own living vessel, for long-term, reliable vascular access.

The commercial launch follows positive 12-month European pivotal data demonstrating secondary patency comparable to matured arteriovenous fistulas (AVFs), alongside lower reintervention rates and high infection resistance compared with historical arteriovenous graft (AVG) benchmarks. It marks the beginning of Xeltis’ broader European rollout of aXess™, providing more physicians and patients with a differentiated vascular access solution that has the potential to transform the hemodialysis treatment landscape.

Dr. Dominik Liebetrau, Head of Vascular Surgery at Artemed Klinikum Munich South, Germany, said: “aXess™ integrated seamlessly into our existing surgical workflow, making adoption straightforward for our team. It offers a fundamentally new approach to vascular access – providing an implant that is designed to transform into the patient's own living vessel. This provides physicians with a valuable new option for patients requiring long-term hemodialysis access and has the potential to improve treatment outcomes and quality of life.”

Eliane Schutte, Chief Executive Officer, Xeltis, added: “The first commercial implantation of aXess™ marks the transition from clinical development into routine patient care. It is an important milestone for Xeltis and the beginning of our European commercial launch, bringing a new treatment option to patients and physicians, while building the foundation for broader adoption across Europe and, ultimately, the U.S.”

Elmar Horn, Vice President of Commercial, Xeltis, said: “Our first commercial implant is a significant milestone for Xeltis and reflects the commitment of our team and our physician partners. Our focus now is on supporting participating centers as they adopt aXess™, delivering a positive experience for patients and physicians, and responsibly expanding patient access across Germany and Europe.”

Peter A. Schneider, Member of the Medical Advisory Board, Xeltis commented: “This is the first time we have access to a non-autologous conduit designed to become the patient’s own vessel over time through vascular cell in-growth and tissue regeneration, ultimately behaving more like an autologous vessel. This approach has the potential to address a significant unmet need in vascular access by combining fast availability for cannulation with the long-term benefits of a living vessel.”

Alongside European commercialization, Xeltis continues enrollment in its US pivotal trial of aXess™, now exceeding 50% enrollment. The study builds on the positive European pivotal data and supports the Company's broader global commercialization strategy.

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 transforms to 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 launch is aXess™, 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/