- 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™ 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.
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