Xeltis has announced the completion of enrolment in its EU pivotal trial for aXess, its restorative vascular access conduit, in adults with end-stage renal disease. The trial is taking place in 22 centres across Europe.
The aXess EU pivotal trial is a prospective study investigating the patency, safety, and performance of aXess in adult patients with end-stage renal disease requiring vascular access to start or maintain haemodialysis therapy. A total of 120 patients have been recruited across 22 centres in nine countries across Europe. This trial follows outstanding 12-month data from the first in human EU trial, which demonstrated a significant improvement in performance compared to current haemodialysis vascular access solutions and showed 0% (zero) infection rate.
Xeltis is currently enrolling up to 140 patients in the aXess US pivotal trial, with John Lucas III, surgeon at Lucas Surgical Group (Greenwood, USA), as the national principal investigator.
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. We extend our thanks to the patients involved, who made it possible to advance this study.”
Paulo Neves, chief medical officer, Xeltis said: “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. We are deeply grateful to the trial participants and all our investigators and study teams.”
Xeltis has also announced the addition of Rob Eyers to its team, bringing over three decades of in-depth experience in the cardiovascular medtech industry, in both corporate and start up environments. He joins from Veryan Medical where he served as CTO, having previously worked for CR Bard (now Medtronic), Merit Medical, Proxy Biomedical, and Boston Scientific. He has a proven track record of taking cardiovascular implant devices through regulatory approval to commercialisation, the company says in a press release.
Eyers, 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 commercialisation 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.”
