Enrollment in Xeltis’ AXESS multi-center clinical trial now successfully completed

Xeltis announced very promising preliminary efficacy and safety results from one of the centers participating in the AXESS first-in-human (FIH) clinical trial of our restorative hemodialysis cardiovascular access graft aXess at the Porto Vascular Congress (PVC) organized by the European Society of Vascular Surgery (ESVS) last weekend. We are also pleased to report that enrolment in the trial is now complete, with 20 patients successfully implanted with the aXess graft.

During hemodialysis, the aXess device demonstrated 100 percent cumulative primary and secondary patency, with an average follow-up time of 5.8 months and no device-related complications in patients implanted by Professor Matteo Tozzi and his team at University of Insubria in Varese (Italy), one of the six European sites participating in the trial. To date, aXess has enabled more than 1200 hemodialysis sessions in just over a year as part of the AXESS FIH trial, of which 60 sessions in Varese.

“Our initial clinical experience with aXess is very promising, from implanting to puncturing, and the data on functionality observed so far very encouraging,” commented Professor Tozzi.

“An access graft able to combine the benefits of immediate hemodialysis start - typical of ePTFE grafts - with a longer durability and reduced complications normally enabled by a fistula, may potentially change the treatment paradigm for vascular access in hemodialysis,” said Professor Mauro Gargiulo, immediate Past President of the ESVS at PVC, who will be leading the next phase of aXess’ clinical investigations. “Particularly for patients who are unsuitable for fistula creation, a longer lasting alternative option to ePTFE grafts is certainly an option worth exploring.”

Xeltis’ aXess is a synthetic, bio-restorative vessel graft device that enables early puncturing needed to connect to the hemodialysis machine. Unlike any currently available options, aXess is also designed to turn into a patient’s own living blood vessel, like an arteriovenous fistula, as its porous structure gets gradually colonized by patient’s own tissue cells. According to the experience in Varese, aXess improved compliance over time, which may result from new tissue forming in the device.

“These exciting early outcomes from the AXESS study confirm the overall very positive progression in clinical trials of our whole restorative cardiovascular technology platform, including coronary artery bypass grafts and heart valves,” said Eliane Schutte, Xeltis CEO.