Xeltis Names Shawn Gage Vice President of US Clinical Affairs

Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, has appointed Shawn Gage as its new Vice President of US Clinical Affairs.

 

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.”

 

Gage has nearly two decades of clinical experience in the hemodialysis and vascular access field and is an expert in hemodialysis access and clinical trial development, design, and strategy. At Xeltis, he hopes to bolster the company’s presence in the vascular and hemodialysis space in the US.

 

He joins Xeltis from InnAVasc Medical, a company he co-founded out of Duke University in 2013 before it was acquired by W. L. Gore & Associates in 2022. After the acquisition, he held the position of Director of Clinical Operations.

 

During this time, InnAVasc Medical advanced its lead medical device technology, a hemodialysis graft, into Phase I/II human clinical trials. Gage was instrumental in formulating the clinical and technical aspects of the IDE submission, as well as the development of the 60-patient clinical trial for FDA 510(k) clearance.

 

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 also recently gained approval from the US 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.