Xeltis has passed the halfway enrolment mark in its US pivotal trial evaluating the aXess vascular access device for adults with end-stage renal disease requiring haemodialysis.

Xeltis announced that more than 50% of patients have now been enrolled in the multicentre US study, which is evaluating the safety, performance and patency of its bioabsorbable aXess vascular access device in adults with end-stage renal disease (ESRD).

The trial is expected to recruit 140 patients across sites in the United States and is designed to assess whether the device can provide reliable long-term vascular access for haemodialysis. The programme received FDA Breakthrough Device Designation in November 2024.

The milestone marks continued progress for Xeltis as it advances the technology towards potential FDA approval. The company said the study has now enrolled more than half of its target population across 20 US clinical sites.

Shawn Gage, vice president of US clinical affairs at 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.”

He added: “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 aXess device is designed to provide vascular access for patients requiring regular haemodialysis by transforming into a living blood vessel after implantation. Reliable vascular access remains one of the major clinical challenges in the management of patients with ESRD, with existing options including arteriovenous fistulas and synthetic grafts each presenting limitations.

The US study builds on encouraging data from the European pivotal trial. Xeltis recently reported positive 12-month results showing higher secondary patency compared with historical benchmarks for conventional arteriovenous grafts, alongside lower reintervention rates and greater resistance to infection. Those findings supported CE mark approval, allowing the company to begin commercialisation in Europe.

John Lucas of Lucas Surgical Group, national principal investigator for the study, said the ongoing trial could help establish the clinical value of the technology.

Lucas said: “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.”

The trial continues to recruit patients across participating US centres as Xeltis works towards completing enrolment and generating the clinical evidence required to support regulatory submissions.