Xeltis announces FDA Breakthrough Device Designation for aXessTM and first patient treated in US pivotal trial

• Designation recognizes aXess has the potential of providing a more effective vascular access option for dialysis patients, bringing significant advantages over current therapies
• First patient treated in US pivotal trial, marking significant clinical milestone

EINDHOVEN, The Netherlands, Nov. 14, 2024 /PRNewswire/ -- Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, today announces that the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has granted aXess Breakthrough Device Designation status. aXess is Xeltis' vascular access conduit, which enables the creation of a new, permanent, living vessel for hemodialysis vascular access.

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."

Dr. John Lucas III, Surgeon at Lucas Surgical Group, P.A. and national Principal Investigator for aXess US pivotal trial, added: "The US trial for aXess is an important step in assessing and validating the ability of this unique conduit to transform the field of vascular access. The 12-month data from the first-in-human study in Europe is extremely promising and I look forward to working on this next clinical stage in Xeltis' journey."

This Breakthrough Device Designation acknowledges that aXess meets the necessary criteria for its proposed use as a vascular prosthesis and that it has the potential of providing a more effective treatment option for patients needing hemodialysis vascular access than current treatments. These benefits include the avoidance of frequent reinterventions and complications, such as infections, which are faced by renal disease patients. The designation grants Xeltis accelerated interactions with FDA review teams, prioritized review, and special reimbursement consideration, positioning the Company for enhanced market access and expediting commercialization for patients in need.

Strong clinical data for aXess will be presented during the VEITH Symposium between November 19-23. On November 23, Dr. John Lucas III will present an update on the US IDE Pivotal Study for aXess, and on November 21, Prof. Frans Moll will present the full 2-year clinical results for aXess.

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.

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.

A first-in-human trial of aXess demonstrated a significant improvement in performance compared to hemodialysis vascular access solutions. A pivotal trial of aXess is currently underway in Europe, with recruitment underway in the US.

Go to axesspivotal.com for more details.

About the FDA Breakthrough Devices Program

The FDA Breakthrough Devices Program aims to provide patients and health care providers with faster access to cutting-edge technologies by accelerating the development, evaluation, and review processes for premarket approval. This designation recognizes those medical devices that meet the FDA's high standards for device safety and effectiveness and are evaluated as significantly improving the diagnosis or treatment of life-threatening or irreversibly debilitating conditions with unmet medical needs.