The study evaluates aXess in adults with end-stage renal disease. Eindhoven, The Netherlands-based Xeltis will conduct the study in 120 subjects across 22 centers in Europe. This study follows 12-month data from a first-in-human EU trial that demonstrated a significant improvement in performance compared to current hemodialysis vascular access solutions and showed 0% infection rate.
aXess enables the creation of a new, permanent, living vessel for hemodialysis vascular access. It combines the safety and patency of arteriovenous fistula (AVF) with the speed to treatment of arteriovenous grafts (AVG). The conduit aims to deliver an improved dialysis patient experience while avoiding reinterventions and complications like infections.
Xeltis designed its implant platform for gradual replacement by the patient’s own living, healthy tissue. The company already used its technology to treat more than 100 patients across different clinical trials. It’s currently enrolling up to 140 patients in a U.S. pivotal trial, too.
“The smooth completion of enrolment speaks to the promising medical profile of aXess and means we are one step closer to improving the standard of care for patients with end-stage renal disease,” said Paulo Neves, Xeltis chief medical officer. I look forward to the progress we are making as we advance towards CE approval. We are deeply grateful to the trial participants and all our investigators and study teams.”
A new executive appointment at Xeltis
In addition to the enrollment milestone, the company named Rob Eyers as its new chief technology officer. Eyers has more than three decades of in-depth experience in the cardiovascular medtech industry, according to a news release.
He joins from Veryan Medical, where he served as CTO as well. Before that, he worked for CR Bard (now Medtronic), Merit Medical, Proxy Biomedical and Boston Scientific.
“Xeltis’ novel endogenous tissue restoration (ETR) technology sets a new benchmark for innovation in medical devices,” Eyers said. “Capable of regenerating a patient’s own tissue while avoiding the frequent reinterventions and infections associated with current treatment options, it has the potential to transform patient outcomes. The company is progressing rapidly towards commercialization and delivering strong clinical results, and I am pleased to be joining such a dynamic team and continuing to build on this strong momentum to fast track regulatory approvals and contribute to the development of the platform.”
