- 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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SOURCE Xeltis