Xeltis announces completion of enrolment in EU Pivotal Trial for aXess and prepares for market approval

-  Enrolment completed - 120 patients with end-stage renal disease in 22 centers in Europe
-  Primary endpoint readouts anticipated in Q2 2025, first market approval expected in 2026
-  Capability to obtain market approval is further strengthened with the appointment of Rob Eyers as Chief Technology Officer.

EINDHOVEN, The Netherlands, Jan. 7, 2025 /PRNewswire/ -- Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, today announces the completion of enrolment in its EU Pivotal trial for aXess, its restorative vascular access conduit, in adults with end-stage renal disease. The trial is taking place in 22 centers across Europe.

The aXess EU pivotal trial is a prospective study investigating the patency, safety, and performance of aXess in adult patients with end-stage renal disease requiring vascular access to start or maintain hemodialysis therapy. A total of 120 patients have been recruited across 22 centers in nine countries across Europe. This trial follows outstanding 12-month data from the first in human EU trial, which demonstrated a significant improvement in performance compared to current hemodialysis vascular access solutions and showed 0% (zero) infection rate.

Xeltis is currently enrolling up to 140 patients in the aXess US pivotal trial, with Dr. John Lucas III, Surgeon at Lucas Surgical Group, P.A., as the National Principal Investigator.

Professor Loreto Gesualdo, Principal Investigator, Bari commented: "I am very proud to be contributing to this EU pivotal trial, which is a vital step towards demonstrating the potential of aXess to transform patient outcomes for those with end-stage renal disease. Xeltis' technology allows for the natural creation of living and long-lasting vessels, effectively addressing the issue of fistula non maturation, without the risk of reverting to catheter use. This results in an improved dialysis patient experience, a clear unmet medical need. We extend our thanks to the patients involved, who made it possible to advance this study."

Paulo Neves, Chief Medical Officer, Xeltis said: "The smooth completion of enrolment speaks to the promising medical profile of aXess and means we are one step closer to improving the standard of care for patients with end-stage renal disease. I look forward to the progress we are making as we advance towards CE approval. We are deeply grateful to the trial participants and all our investigators and study teams."

Rob Eyers brings over three decades of in-depth experience in the cardiovascular medtech industry, in both corporate and start up environments.  He joins from Veryan Medical where he served as CTO, having previously worked for CR Bard (now Medtronic), Merit Medical, Proxy Biomedical, and Boston Scientific. He has a proven track record of taking cardiovascular implant devices through regulatory approval to commercialization.

Rob Eyers, newly appointed Chief Technology Officer, Xeltis said: "Xeltis' novel Endogenous Tissue Restoration (ETR) technology sets a new benchmark for innovation in medical devices. Capable of regenerating a patient's own tissue while avoiding the frequent reinterventions and infections associated with current treatment options, it has the potential to transform patient outcomes. The Company is progressing rapidly towards commercialization and delivering strong clinical results, and I am pleased to be joining such a dynamic team and continuing to build on this strong momentum to fast track regulatory approvals and contribute to the development of the platform."

More details of the aXess EU Pivotal study can be found at clinicaltrials.gov under the identifier NCT05473299 or go to axesspivotal.com.

About Xeltis
Xeltis is a medtech company developing transformative implants that enable the natural creation of living and long-lasting vessels. Xeltis seeks to address the limitations of currently available options for the millions of people requiring hemodialysis access grafts or cardiovascular replacements every year. The Company's proprietary endogenous tissue restoration (ETR) platform utilizes an advanced polymer implant which regenerates the patient's own tissue before gradually being absorbed and leaving new, living, and long-lasting vessels in place. Xeltis' most advanced product currently under clinical development is aXess^TM, an implantable blood vessel for hemodialysis vascular access. Xeltis' groundbreaking technology has high potential to be applied to other major vascular and cardiovascular diseases. 

Xeltis is based in The Netherlands and the USA. Its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, Ysios Capital, Grand Pharma Group, the European Innovation Council and Invest-NL, in addition to other public and private investors.

Visit the Xeltis website for more details: https://xeltis.com/

About aXess
aXess is a restorative conduit which enables the creation of a new, permanent, living vessel for hemodialysis vascular access. It combines the safety and patency of a fistula with the speed to treatment of an AV graft. The aXess vascular access conduit offers an improved dialysis patient experience and avoids the frequent reinterventions and complications, such as infections, faced by renal disease patients.

About Rob Eyers
Throughout his career, Rob has gained cross-functional experience in both corporate and start up environments, having previously worked for CR Bard (Now Medtronic), Merit Medical, Proxy Biomedical, and Boston Scientific where he served as Research & Development Director. He is the Co-Founder, Principal Consultant and Managing Director of Blue Pearl Medical, a medtech consultancy that supports all aspects of developing and taking medical device products and technologies through to global markets.

Most recently, during his time at Veryan Medical, he was responsible for all product development and innovation activities within the company. He spearheaded the stent & delivery system development and FDA submission achieving one of the fastest premarket approvals for a novel peripheral arterial self-expanding stent (Class III device). This achievement was instrumental for Veryan's acquisition by Otsuka Medical Device, a Japanese corporate.

SOURCE Xeltis