Xeltis Reaches Halfway Point in aXess Study Enrollment

Xeltis has surpassed 50% enrollment in its U.S. pivotal trial for aXess, a vascular access device that transforms into a living vessel for reliable hemodialysis access in adults with end-stage renal disease (ESRD).

The trial is a prospective, multicenter study evaluating the patency, safety, and performance of aXess in adult ESRD patients who require vascular access for hemodialysis. To date, more than 50% of the target patient enrollment has been achieved across 20 U.S. sites, marking significant headway toward the trial’s planned 140-patient enrollment. The study is supported by the U.S. Food and Drug Administration’s (FDA) Breakthrough Device Designation, which was granted in November 2024.

“Reaching this milestone reflects the strong momentum behind the aXess program as we advance towards FDA approval in the U.S.,” Xeltis U.S. Clinical Affairs Vice President Shawn Gage said. “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.”

U.S. pivotal trial sites include: AKDHC Medical Research Services LLC in Phoenix, Ariz.; American Access Care (AAC) in Miami; Sarasota Memorial Hospital in Sarasota, Fla.; Emory University Hospital in Atlanta, Ga.; Brigham and Women’s Hospital in Boston; Greenwood Leflore Hospital in Greenwood, Miss.; Surgical Specialists of Charlotte in Charlotte, N.C.; Duke University Hospital in Durham, N.C.; Raleigh Access Center in Raleigh, N.C.; Medical University of South Carolina (MUSC) in Charleston, S.C.; Columbia in Columbia, S.C.; MUSC Health in Orangeburg, S.C.; Spartanburg Regional Medical Center in Spartanburg, S.C.; University Vascular Access in Memphis, Tenn.; Baylor Scott & White Health in Dallas; Flow Vascular Institute in Houston; and Houston Methodist Hospital in Houston.

The U.S. study builds on recently presented positive 12-month data from the EU pivotal trial, which demonstrated higher secondary patency of aXess compared with the historical benchmark of conventional arteriovenous grafts (AVGs) and comparable to mature 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.

“This study represents an important step in demonstrating the potential of aXess to improve outcomes for patients with ESRD requiring hemodialysis access,” stated national principal investigator Dr. John Lucas III, of Lucas Surgical Group P.A. “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 U.S. pivotal trial, added: “I love it! I recommend it to people now. The one that I have I feel like it works 100% satisfactorily, and I recommend it to people all the time!”

Xeltis is 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 those requiring hemodialysis access grafts or cardiovascular replacements. The company’s proprietary Restorex platform utilizes an advanced polymer implant that regenerates a patient’s own tissue before gradually being absorbed and leaving new, living, long-lasting vessels in place. Xeltis’ most advanced product currently under commercial development is aXess, an implantable blood vessel for hemodialysis vascular access. Xeltis’ technology could 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.