Concurrently, following IDE approval from the FDA, the first patient in aXess’ US-staged pivotal trial has now been enrolled and treated at the Flow Vascular Institute in Houston, Texas, by Dr. Karl Illig, marking a significant clinical milestone for Xeltis.

Eliane Schutte, Chief Executive Officer, Xeltis commented: “We are in a transformative period for Xeltis, and this designation from the FDA is great recognition of the potential importance of our highly novel technology. We are also extremely proud that the first patient in our US pivotal trial has now been treated, and this clinical achievement provides us with significant momentum as we advance towards commercialization.”

Dr. Karl Illig, Vascular Surgeon and site Principal Investigator for aXess US pivotal trial, said: “aXess has the potential to be a truly groundbreaking advance in the vascular access field, as it enables the creation of a new, permanent, living vessel. We hope that its ability to avoid the frequent reinterventions and infections associated with current treatment options will make a major difference to patients and their care.”