Xeltis, a medtech company focused on regenerative implants, has announced compelling 12-month data from its first-in-human (FIH) trial of aXess, a vascular conduit designed for hemodialysis access. The data, presented at the 50th Annual VEITHsymposium, demonstrated exceptional patency rates and a complete absence of infections in the treated patients.
The aXess FIH trial (NCT04898153) is a single-arm feasibility study conducted across six centers in Europe. It enrolled patients with end-stage renal disease who were unsuitable for fistula creation. The study evaluated the safety and performance of the aXess graft over a five-year follow-up period. The latest data set includes 20 patients who have reached the 12-month milestone.
Key Findings from the aXess FIH Trial
The 12-month data revealed a 100% secondary patency rate and a 78% primary assisted patency rate. Notably, no infections were reported among the patients implanted with the aXess conduit. These results suggest a significant improvement over the current standard of care for hemodialysis vascular access, which often involves frequent interventions and carries a risk of infection.
Professor Dr. Frans Moll, a vascular surgeon at the University Medical Centre Utrecht and a member of Xeltis’ Medical Advisory Board, commented on the results: “The 12-month data from the aXess FIH trial are highly encouraging and continue to demonstrate the potential of the aXess vascular conduit to combine the early benefits of AVG, such as early cannulation and no maturation needed, with the long-term advantages of AVF, including better patency rates, a reduced need for intervention, and low infection rates.”
The aXess Technology
aXess is a restorative conduit engineered to facilitate the creation of a new, long-term living vessel for hemodialysis vascular access. The device leverages Xeltis' proprietary endogenous tissue restoration (ETR) platform, which utilizes an advanced polymer implant to regenerate the patient’s own tissue. Over time, the polymer implant is gradually absorbed, leaving behind a new, living, and long-lasting vessel.
Ongoing Pivotal Trial
Building on the promising FIH data, Xeltis has initiated a pivotal trial of aXess, enrolling up to 110 patients across up to 25 sites in nine EU countries. Over 40 patients have already been implanted in this trial. This pivotal study aims to further evaluate the safety and efficacy of aXess in a larger patient population and support regulatory submissions for market approval.
Eliane Schutte, CEO of Xeltis, stated, “The outstanding 12-month data from our FIH study highlights aXess’ potential to transform the field of vascular access as a whole by stopping the cycle of interventions and infections. These latest results, alongside the excellent progress in enrollment for our pivotal trial, brings us closer to bringing our breakthrough solution to hemodialysis patients worldwide.”
