Xeltis Texas

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 therapiesFirst patient treated in US pivotal trial, marking significant clinical milestonebetween 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 aXessTM, 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.

View original content:https://www.prnewswire.co.uk/news-releases/xeltis-announces-fda-breakthrough-device-designation-for-axesstm-and-first-patient-treated-in-us-pivotal-trial-302304671.html