Xeltis has announced initiation of a clinical trial evaluating Axess, which it claims is the first ever restorative synthetic haemodialysis access graft. Several patients with kidney failure or advanced kidney disease requiring dialysis have already been successfully implanted as part of the European first-in-human trial to date, a press release states.
Axess grafts enable early puncturing, or initiation of dialysis, shortly after implanting—according to a Xeltis press release. Overtime, they turn into living blood vessels as their porous microstructure is colonised by the patient’s own tissue.
Today, the release continues, patients with kidney failure may wait for months, sometimes in vain, for their fistula to mature into a functional dialysis access, or they will use synthetic grafts that have limited durability and are prone to clotting and infections.
“An off-the-shelf haemodialysis access solution capable of turning into a patient’s living vessel would combine the benefits of arteriovenous fistulas and grafts with none of their current, limiting compromises,” said Matteo Tozzi, a vascular surgeon at the University of Insubria in Varese, Italy and one of the trial’s investigators. “Patients with renal failure would be relieved by a significant clinical, physical and psychological burden if access to dialysis became straightforward and reliable.”
The first-in-human Axess trial will evaluate the preliminary safety and performance of the graft in 15 end-stage kidney disease (ESKD) patients enrolled across five European sites. It is a prospective, single-arm, non-randomised feasibility study, according to Xeltis, and its primary endpoints are freedom from device-related serious adverse events during the first six months after implantation and functional patency rate at six months.
Xeltis also recently received €15 million in funding from the European Innovation Council (EIC) accelerator, comprising €2.5 million in grants and up to €12.5 million in equity that the company will use to support the clinical trial programme for its XABG device—a restorative coronary artery bypass graft (CABG).