Brings extensive experience in design, development, and implementation of US medtech clinical trial strategy for hemodialysis and vascular access

Follows expansion of Xeltis’ clinical presence in the US after recent IDE approval for aXess^TM US pivotal trial

EINDHOVEN, Netherlands, July 23, 2024 /PRNewswire/ — Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announces that it has appointed Shawn Gage as its new Vice President of US Clinical Affairs.

His appointment comes at a pivotal time for Xeltis, with the Company advancing the initiation of its US pivotal trial for aXess, its restorative vascular access conduit. Shawn is an expert in hemodialysis access and clinical trial development, design, and strategy, and will bolster Xeltis’ presence in the vascular and hemodialysis space in the US.

Paulo Neves, Chief Medical Officer, Xeltis commented: “Shawn’s appointment is emblematic of Xeltis’ increasing clinical presence in the US. His experience designing and implementing clinical trials means he is the perfect candidate to lead our US pivotal trial strategy following our recent IDE approval.”

Shawn Gage, Vice President of US Clinical Affairs, Xeltis said: “Over the course of my years working as a vascular access surgeon and then directing clinical trials in this complex space, I have become very familiar with the work Xeltis is doing and its transformative implants. I am extremely motivated to help Xeltis develop a US clinical strategy to help bring our groundbreaking regenerative implants to patients in need.”

Xeltis recently announced that it has gained approval from the US Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) submission to begin enrolling patients into a pivotal study for aXess. The US-based pivotal trial follows strong 12-month data from the first-in-human trial in Europe in comparison to hemodialysis vascular access solutions. aXess is also undergoing an EU pivotal trial, recruiting up to 110 patients in nine EU countries.

Shawn boasts nearly two decades of valuable clinical experience in the hemodialysis and vascular access field. He joins from InnAVasc Medical, a company he co-founded out of Duke University in 2013 before it was acquired by W. L. Gore & Associates, Inc. (Gore) in 2022, where he held the position of Director of Clinical Operations. During this time, the Company advanced its lead medical device technology, a hemodialysis graft, into Phase I/II human clinical trials, with Shawn being instrumental in formulating the clinical and technical aspects of the IDE submission, as well as the development of the pivotal 60 patient clinical trial for FDA 510(k) clearance.

Prior to this, Shawn held the position of Clinical Liaison, Clinical Development at Humacyte, Inc., after leaving a well-respected vascular practice at Duke University, during which time the Company undertook Phase II and III human clinical research for its vascular tissue technology.

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™, 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 enrolling up to 110 patients in nine EU countries.

Go to axesspivotal.com for more details.