Xeltis, a Netherlands-based medical technology company, has announced the completion of enrollment in its EU pivotal trial for aXess, a restorative vascular access conduit designed for adult patients with end-stage renal disease requiring hemodialysis. The trial, conducted across 22 centers in nine European countries, marks a significant milestone in the development of innovative solutions for vascular access.
The aXess EU pivotal trial is a prospective study evaluating the patency, safety, and performance of the aXess device. A total of 120 patients have been enrolled to assess the conduit's effectiveness in facilitating vascular access for hemodialysis. This trial builds upon promising 12-month data from a first-in-human EU trial, which demonstrated a significant improvement in performance compared to current hemodialysis vascular access solutions and a 0% infection rate.
Professor Loreto Gesualdo, Principal Investigator, Bari, Italy, commented, "I am very proud to be contributing to this EU pivotal trial, which is a vital step towards demonstrating the potential of aXess to transform patient outcomes for those with end-stage renal disease. Xeltis' technology allows for the natural creation of living and long-lasting vessels, effectively addressing the issue of fistula non maturation, without the risk of reverting to catheter use. This results in an improved dialysis patient experience, a clear unmet medical need."
aXess aims to create a new, permanent, living vessel for hemodialysis vascular access by combining the safety and patency of arteriovenous fistulas (AVF) with the speed to treatment of arteriovenous grafts (AVG). The device is designed to improve the dialysis patient experience and reduce the need for reinterventions and address complications such as infections.
Xeltis's implant platform is designed for gradual replacement by the patient's own tissue. The company is also enrolling up to 140 patients in the aXess US pivotal trial.
Anticipated Market Approval and Executive Appointment
Primary endpoint readouts from the EU pivotal trial are anticipated in Q2 2025, with the first market approval expected in 2026. Xeltis has also announced the appointment of Rob Eyers as Chief Technology Officer. Eyers brings over three decades of experience in the cardiovascular medtech industry, having previously worked for Veryan Medical, CR Bard (now Medtronic), Merit Medical, Proxy Biomedical, and Boston Scientific.
Paulo Neves, Chief Medical Officer, Xeltis, stated, "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. I look forward to the progress we are making as we advance towards CE approval."
Rob Eyers, the newly appointed Chief Technology Officer, Xeltis, said, "Xeltis' novel Endogenous Tissue Restoration (ETR) technology sets a new benchmark for innovation in medical devices. 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."
