GI Dynamics Announces New Scientific Advisory Board and Board’s First Two Members
March 06 2017 - 6:57PM
Business Wire
GI Dynamics®, Inc. (ASX:GID), a medical device company that has
commercialized EndoBarrier® in Europe, the Middle East and South
America for patients with type 2 diabetes and obesity, announced
the creation of the GI Dynamics Scientific Advisory Board (SAB).
The GI Dynamics SAB will endeavor to bring together distinguished
physicians and scientists specializing in endocrinology,
gastroenterology and metabolic surgery to advance the
evidence-based understanding of EndoBarrier and support its optimal
usage. Professor Carel Le Roux, MD, PhD and Professor Jan Willem
Greve, MD, PhD, are the first two members to join the SAB.
The GI Dynamics SAB was created to help the company advance the
body of evidence supporting clinical use of EndoBarrier, ask and
answer relevant questions about the treatment paradigm and advance
the state of patient care for type 2 diabetes and obesity. The
group will serve as a critical resource to GI Dynamics during the
investigational device exemption trial of EndoBarrier in the United
States, and will support ongoing clinical studies and
commercialization in the United Kingdom, Germany, the Middle East
and additional European countries.
“We look forward to working with professors Le Roux and Greve to
help us improve clinical options for patients with type 2 diabetes
and obesity with EndoBarrier,” said Scott Schorer, GI Dynamics
president and CEO. “As an endocrinologist, professor Le Roux brings
a deep understanding of the disease states we are treating.
Professor Greve, who has been a primary investigator on two
EndoBarrier trials, brings the perspective of an experienced
bariatric / metabolic surgeon.”
Le Roux serves as the head of pathology at the University
College Dublin in Ireland. He graduated from medical school in
Pretoria, South Africa, where he completed his specialist training
in metabolic medicine at St. Bartholomew’s Hospitals and
Hammersmith Hospitals. He completed his PhD at Imperial College
London and was later promoted to Reader. He received a Clinician
Scientist Award from the UK National Institute of Health Research
and a Wellcome Trust Clinical Research Fellowship for his work on
how the gut communicates with the brain.
“Type 2 diabetes remains one of the most challenging chronic
diseases people struggle with. Novel and scalable treatments that
can have a positive impact on people’s lives are urgently needed,”
said Le Roux. “EndoBarrier has broken the mold of how we used to
think about novel treatments for diabetes.”
Greve serves as medical director of the Dutch Obesity Clinics
South and chair of the Metabolic and Bariatric Surgery Unit at the
Zuyderland Medical Center in the Netherlands. Greve received his
PhD at the Academic Hospital in Maastricht, Netherlands, has served
on numerous committees, supervised 15 doctoral theses and authored
more than 185 peer-reviewed papers and numerous book chapters on
intensive care medicine, nutrition and bariatric and metabolic
surgery. He was principal investigator of two European EndoBarrier
clinical trials and other single-center and multicenter
studies.
“Obesity and its co-morbidities are an immense challenge for
modern health care,” said Greve. “Bariatric or metabolic surgery is
a proven tool to treat morbidly obese patients with type 2
diabetes. However, the majority of these patients may have a BMI
that is too low or have serious contraindications that preclude
them from being candidates for such an invasive surgical procedure.
As a bariatric / metabolic surgeon, I believe EndoBarrier is a
powerful addition to our treatment armamentarium.”
About GI Dynamics
GI Dynamics, Inc. (ASX:GID), is the developer of EndoBarrier,
the first endoscopically delivered device approved for the
treatment of type 2 diabetes and obesity. EndoBarrier is approved
and commercially available in multiple countries outside the United
States. EndoBarrier is not approved for sale in the United
States and is limited by federal law to investigational use only in
the United States. Founded in 2003, GI Dynamics is headquartered in
Boston, Massachusetts. For more information, please
visit www.gidynamics.com.
Forward-Looking Statements
This announcement contains forward-looking statements concerning
our development and commercialization plans, potential revenues and
revenue growth, costs, excess inventory, profitability and
financial performance, ability to obtain reimbursement for our
products, clinical trials and associated regulatory submissions and
approvals, the number and location of commercial centers offering
the EndoBarrier, and our intellectual property position. These
forward-looking statements are based on GI Dynamics’ management’s
current estimates and expectations of future events as of the date
of this announcement. Furthermore, the estimates are subject to
several risks
and uncertainties that could cause actual results to differ
materially and adversely from those indicated in or implied by such
forward-looking statements. These risks and uncertainties include
but are not limited to, risks associated with the consequences of
stopping the ENDO trial and the possibility that future clinical
trials will not be successful or confirm earlier results. Further
risks are associated with obtaining funding from third parties; the
timing and costs of clinical trials; the timing of regulatory
submissions; and the timing, receipt and maintenance of regulatory
approvals. The timing and amount of other expenses and the timing
and extent of third-party reimbursement risks associated with
commercial product sales, including product performance,
competition, risks related to market acceptance of products,
intellectual-property risk; risks related to excess
inventory; and risks related to assumptions regarding the size
of the available market, the benefits of our products, product
pricing, timing of product launches, future financial results and
other factors, including those described in our filings with the
U.S. Securities and Exchange Commission. Given these uncertainties,
one should not place undue reliance on these forward-looking
statements. We do not assume any obligation to publicly update or
revise any forward-looking statements, whether as a result of new
information or future events or otherwise, unless we are required
to do so by law.
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