Xeltis has initiated the clinical trial for aXess, 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 a European first-in-human trial to date.

The aXess grafts enable early puncturing, or initiation of the dialysis, shortly after implanting. Overtime, they turn into living blood vessels, as their porous micro-structure get colonized by the patient’s own tissue. Today, patients with kidney failure may wait for months, or in vain, for fistula maturation to access dialysis or they use synthetic grafts that have limited durability and are prone to clotting and infections.[1],[2]

“An off-the-shelf hemodialysis access solution capable of turning into a patient’s living vessel would combine the benefits of arterio-venous fistulas and grafts, with none of their current, limiting compromises,” said Professor Matteo Tozzi, vascular surgeon, Università dell’Insubria, Varese (Italy), 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.”

“We are incredibly proud of the fast progression of aXess, our innovative solution for hemodialysis access, into clinical development,” said Dr Jochen Reinöhl, Xeltis CMO. “It is a medical area with very clear, unmet needs that our advanced technology platform could address, to ultimately and significantly improve patients’ lives.”

[1] Lee T et al. Tradeoffs in Vascular Access Selection in Elderly Patients Initiating Hemodialysis with a Catheter. American Journal of Kidney Diseases. Volume 72, Issue 4, October 2018, Pages 509-518

[2] Schwab SJ et al. Vascular access for hemodialysis. Kidney International. 1999 May;55(5):2078-90. doi: 10.1046/j.1523-1755.1999.00409.x. PMID: 10231476.