Xeltis has reached more than 50% enrolment in its US pivotal trial of aXess, a vascular access device designed for adults with end-stage renal disease who require haemodialysis.
The ongoing, prospective, multi-centre trial is underway at 20 sites across the US and will assess the device’s patency, safety and performance. The company plans to enrol 140 patients in total.
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The aXess device is intended to transform into a living blood vessel after implantation, providing long-term access for haemodialysis.
In November 2024, the US Food and Drug Administration (FDA) granted the device breakthrough device designation, supporting the progress of the clinical trial.
Xeltis US clinical affairs vice-president Shawn Gage said: “Reaching this milestone reflects the strong momentum behind the aXess programme as we advance towards FDA approval in the US.
“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.”
The trial follows European studies, where 12-month results from a pivotal trial indicated that aXess demonstrated higher secondary patency compared to historical results from conventional arteriovenous grafts and performance similar to matured fistulas.
The device was also associated with fewer reinterventions and increased resistance to infection. Those findings contributed to the device receiving CE mark approval, paving the way for commercial availability in Europe.
Xeltis develops implants intended to regenerate living, long-lasting blood vessels using its Restorex platform. The company’s primary product under commercial development is the aXess device for haemodialysis vascular access.
In July 2025, Xeltis reported positive preliminary data for its Xabg coronary artery bypass conduit (CABG) in a clinical trial at various EU sites.
