Xeltis exceeds 50% enrollment in US Pivotal trial for aXess™, its vascular access device for hemodialysis

• US pivotal trial is a multi-center study evaluating a bioabsorbable hemodialysis vascular access implant across complex hemodialysis patients representing real-world practice
• > 50% of target enrollment reached across 20 sites in the United States
  
  

EINDHOVEN, The Netherlands, July 02, 2026 (GLOBE NEWSWIRE) -- Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, today announces that it has reached 50% enrollment in its US pivotal trial for aXess™, its vascular access device that transforms into a living vessel for reliable hemodialysis access in adults with end-stage renal disease (ESRD).

The US pivotal trial is a prospective, multicenter study evaluating the patency, safety, and performance of aXess™ in adult patients with ESRD requiring vascular access for hemodialysis. To date, over 50% of the target patient enrollment has been achieved across 20 sites in the US, marking a significant milestone towards the planned enrollment of 140 patients in total. The study is supported by the FDA’s Breakthrough Device Designation, which was granted in November 2024.

Shawn Gage, Vice President of US Clinical Affairs, Xeltis, said: “Reaching this milestone reflects the strong momentum behind the aXess™ program as we advance towards FDA approval in the US. We are proud to witness true dedication, engagement, and excitement of our teams, investigators, and clinical partners. This achievement would not have been possible without the trust and commitment of the patients participating in the study, and we extend our sincere thanks to them and to the clinical sites for their continued support in executing this trial with excellence.”

Dr. John Lucas III of Lucas Surgical Group, P.A., National Principal Investigator, commented: “This study represents an important step in demonstrating the potential of aXess™ to improve outcomes for patients with ESRD requiring hemodialysis access. aXess™ is a unique technology, and it is encouraging to see the continued progress of the study as we work to validate its promise in transforming the hemodialysis landscape. We are deeply grateful to the patients whose participation makes this important work possible.”

A patient with the aXess™ implant who is participating in the US pivotal trial, added: “I love it! I recommend it to people now. The one that I have I feel like it works 100% satisfactory and I recommend it to people all the time!”

This US study builds on recently presented positive 12-month data from the EU pivotal trial, which demonstrated higher secondary patency of aXess™ compared with historical benchmark of conventional arteriovenous grafts (AVGs) and comparable to matured fistulas, alongside lower reintervention rates, and enhanced resistance to infection. These data supported CE mark approval, enabling commercialization in Europe and providing clinicians and patients with a novel solution that meets high standards of safety, performance, and clinical evidence.

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™, 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/

US pivotal trial sites

AKDHC Medical Research Services, LLC in Phoenix, Arizona; American Access Care (AAC) in Miami, Florida; Sarasota Memorial Hospital in Sarasota, Florida; Emory University Hospital in Atlanta, Georgia; Brigham and Women’s Hospital in Boston, Massachusetts; Greenwood Leflore Hospital in Greenwood, Mississippi; Surgical Specialists of Charlotte in Charlotte, North Carolina; Duke University Hospital in Durham, North Carolina; Raleigh Access Center in Raleigh, North Carolina; Medical University of South Carolina (MUSC) in Charleston, South Carolina; Columbia in Columbia, South Carolina; MUSC Health in Orangeburg, South Carolina; Spartanburg Regional Medical Center in Spartanburg, South Carolina; University Vascular Access in Memphis, Tennessee; Baylor Scott & White Health in Dallas, Texas; Flow Vascular Institute in Houston, Texas; and Houston Methodist Hospital in Houston, Texas.

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