Xeltis has announced today the appointment of Shawn Gage as its new vice president of US clinical affairs. The company stated that his appointment comes at “a pivotal time”, at which it is advancing the initiation of its US-based pivotal trial for aXess, its restorative vascular access conduit. Gage is an expert in haemodialysis access and clinical trial development, design, and strategy, and Xeltis hopes that he will bolster the company’s presence in the vascular and haemodialysis space in the USA.
Gage, with nearly two decades of valuable clinical experience in the haemodialysis and vascular access field, joins Xeltis from InnAVasc Medical, a company he co-founded out of Duke University in 2013 before it was acquired by 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 haemodialysis graft, into Phase I/II human clinical trials, with Gage being instrumental in formulating the clinical and technical aspects of the investigational device exemption (IDE) submission, as well as the development of the pivotal 60-patient clinical trial for US Food and Drug Administration (FDA) 510(k) clearance.
Prior to this, Gage held the position of clinical liaison, clinical development at Humacyte, after leaving a vascular practice at Duke University, during which time the company undertook Phase II and III human clinical research for its vascular tissue technology.
Paulo Neves, chief medical officer (CMO) for Xeltis, commented: “Shawn’s appointment is emblematic of Xeltis’ increasing clinical presence in the USA. 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 also commented on his recent appointment, stating: “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 has also recently announced that it has gained approval from the US FDA for an 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 haemodialysis vascular access solutions. aXess is also undergoing an EU pivotal trial, recruiting up to 110 patients in nine countries.
