Xeltis appoints Shawn Gage as Vice President of US Clinical Affairs

EINDHOVEN, The Netherlands, 23 July 2024

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.