Xeltis Completes Enrolment for aXess Trial and Readies for Market Entry

Transformative Milestone in Vascular Access Technology

Xeltis, a frontrunner in the development of innovative implants, has recently announced a significant milestone: the completion of patient enrolment in its EU pivotal trial for aXess, a groundbreaking restorative conduit designed for vascular access in individuals facing end-stage renal disease. Conducted across 22 centers in nine European countries, this trial involved the recruitment of 120 patients, aiming to assess the safety, patency, and overall performance of aXess in supporting hemodialysis therapy.

This pivotal trial builds on promising results from earlier studies. Notably, data from the first-in-human EU trial revealed a remarkable 0% infection rate, alongside an impressive performance improvement compared to existing hemodialysis options. Such findings are crucial as many patients struggle with the complications associated with traditional vascular access methods, particularly the issues surrounding fistula maturation.

Professor Loreto Gesualdo, the Principal Investigator of the trial, expressed pride in contributing to this essential research. "The potential of aXess to enhance patient outcomes is significant, effectively addressing a pressing medical need. This technology creates a new, living vessel which can offer improved experiences for dialysis patients while minimizing the risk of reverting to catheter use."

In parallel, Xeltis is progressing with its US pivotal trial, currently enrolling up to 140 patients under the supervision of Dr. John Lucas III, a respected surgeon recognized for his expertise in this field.

Paulo Neves, Chief Medical Officer at Xeltis, emphasized the importance of this enrolment completion, stating, "This pivotal moment brings us closer to elevating the standard of care for patients with end-stage renal disease. Our thanks extend to the trial participants and our dedicated study teams, whose commitment is integral to our advancement."

Further strengthening its capabilities, Xeltis appointed Rob Eyers as Chief Technology Officer. Eyers, with over thirty years of experience in cardiovascular medtech, brings invaluable expertise to the team. He has demonstrated a successful history of guiding medical devices through regulatory approvals and onto the market. Eyers is optimistic about the potential of Xeltis' Endogenous Tissue Restoration (ETR) technology, which aims to eradicate the frequent reinterventions typically associated with current treatment options. "Our technology can regenerate a patient’s own tissue, and as we progress toward commercialization, I look forward to being part of this innovative team,” he stated.

The aXess conduit represents a new frontier in creating living vessels for vascular access, promising significant improvement in patient care by combining the benefits of both fistulas and traditional grafts. The goal is not only to improve safety and effectiveness but also to enhance the overall patient experience, addressing the often-overlooked complications faced by this patient population.

As Xeltis continues its march toward market approval, expectations are high for the upcoming readouts anticipated in the second quarter of 2025, paving the way for potential market entry in 2026. This trial is more than just a clinical study; it embodies hope for countless patients who rely on dependable and effective vascular access for their lifesaving hemodialysis treatments.

For more detailed information regarding the aXess EU Pivotal study, interested parties can visit clinicaltrials.gov, referencing the identifier NCT05473299, or check axesspivotal.com for updates.

Xeltis remains dedicated to overcoming the limitations inherent in existing treatment options, ensuring that millions of individuals requiring hemodialysis access grafts or cardiovascular replacements receive not only superior solutions but a better quality of life.

As the medical landscape continues to evolve, the role of innovative technologies like aXess will be paramount in enhancing the standards of care within renal disease treatment.