Company Treats First Patients with the EndoBarrier and Establishes Centers of Excellence in Austria; Distribution Agreement for the EndoBarrier in Austria
LEXINGTON, Mass. & SYDNEY--(BUSINESS WIRE <http://www.businesswire.com>
)-- GI Dynamics, Inc. <http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.gidynamics.com&esheet=6868492&lan=en-US&anchor=GI+Dynamics%2C+Inc.&index=1&md5=33d85b75acdb2b9c93772d1ee91a97d2>
(ASX: GID) today announced the launch of the EndoBarrier® Gastrointestinal
Liner (the EndoBarrier) in Austria, the establishment of the first two Centers
of Excellence and the treatment of patients at each new Center.
The Barmherzige Brüder Hospital and the Hallein
Clinic are the first Centers of Excellence established by GI Dynamics in
Austria. Both centers are very experienced in the field of metabolic disorders
and are well known for their publications in the field. All EndoBarriers used in
the procedures were either paid for by the hospital or by the patients.
Austria has a significant type 2 diabetic population, estimated by the World
Health Organization to be more than 600,000 adult patients and an obese
population (Body Mass Index greater than 30) of nearly 700,000 adult patients.
As in the rest of the world, both type 2 diabetes and obesity are increasing
rapidly in Austria.
“There is an urgent need for less invasive, yet effective treatments for type 2
diabetes and obesity,” said Helmut G. Weiss, M.D., M.Sc., associate professor of
surgery and head of the general surgery department at Barmherzige Brüder
Hospital. “We see many patients for whom existing pharmaceutical and lifestyle
treatments are not effective in helping them manage their blood sugar levels or
produce the weight loss they need. The EndoBarrier has the potential to assist
many Austrians living with type 2 diabetes and obesity control their diabetes
and lose weight.”
“Through one therapeutic
approach, the EndoBarrier can help people control their glucose levels and lose
weight at the same time,” said Karl A. Miller, M.D., FACS, associate professor
of surgery, head of the surgical department at Hallein Clinic and president of
the International Federation for the Surgery of Obesity and Metabolic Disorders
(IFSO). “We are delighted to be a Center of Excellence and to offer the
EndoBarrier therapy to our patients.”
The EndoBarrier Centers of Excellence are recognized for
their expertise in the treatment and management of type 2 diabetes and obesity,
and support programs for patients undergoing treatment for these conditions. A
hospital is certified as an EndoBarrier Center of Excellence following a
rigorous training and proctorship program conducted by GI Dynamics in
collaboration with global experts in type 2 diabetes and obesity management.
In addition, GI Dynamics announced it has entered into an agreement with D/A/CH
Medical Group, for the distribution of the EndoBarrier in Austria. The agreement
provides D/A/CH Medical Group the rights to sell and distribute the EndoBarrier
within this territory subject to certain minimums and other provisions.
“We are pleased to designate Barmherzige Brüder and Hallein Clinic as Centers of
Excellence and to be working with D/A/CH Medical Group to make the EndoBarrier
broadly available to the physician and patient community in Austria,” stated
Stuart A. Randle, chief executive officer of GI Dynamics. “At the same time, we
look forward to expanding the availability of the EndoBarrier to additional
Centers of Excellence in Europe, Australia and the Pacific Rim, and South
America.”
Results from clinical studies involving more than 500
patients have demonstrated that treatment with the EndoBarrier may significantly
improve patients’ HbA1c (glucose) levels, enable substantial weight loss, and
improve other metabolic functions including cholesterol, blood sugar and
triglycerides.
The EndoBarrier has received CE mark approval in Europe <http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Finvestor.gidynamics.com%2Fphoenix.zhtml%3Fc%3D247553%26p%3Dirol-newsArticle%26ID%3D1597123%26highlight%3D&esheet=6868492&lan=en-US&anchor=CE+mark+approval+in+Europe&index=2&md5=1cf822e38d2d932a478c87b2c4cf6366>
for periods of up to 12 months of treatment for type 2 diabetes and obesity.
The EndoBarrier is inserted in a procedure that generally takes less than 30
minutes and it remains in the body for up to 12 months. It can be easily removed
in a non-surgical procedure of approximately 15 minutes.
In addition to Austria, the EndoBarrier is currently commercially
available through Centers of Excellence in Chile, Germany, the United Kingdom
and the Netherlands, and recently received TGA approval <http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Finvestor.gidynamics.com%2Fphoenix.zhtml%3Fc%3D247553%26p%3Dirol-newsArticle%26ID%3D1597093%26highlight%3D&esheet=6868492&lan=en-US&anchor=TGA+approval&index=3&md5=192408b946785d0935342a1939d93d00>
in Australia. GI Dynamics also received an investigational device exemption
approval to commence a pilot trial of the EndoBarrier in the U.S.
Type 2 diabetes, which accounts for approximately 90 percent of all cases of
diabetes, occurs when the pancreas has reduced effectiveness in insulin
production associated with an increase in insulin resistance. The diagnosis of
type 2 diabetes usually occurs after the age of 40 and is often, but not always,
associated with obesity. The International Diabetes Federation has estimated
that approximately 250 million people have type 2 diabetes worldwide.
About GI Dynamics
GI Dynamics, Inc. (ASX: GID) is pioneering the development and commercialization
of effective, non-surgical treatments targeting the large and growing global
patient populations with type 2 diabetes and obesity. The company’s flagship
product, the EndoBarrier®, is a novel, non-surgical device proven to lower blood
glucose levels and promote weight loss in diabetic and obese patients during the
implant period. GI Dynamics currently markets the EndoBarrier in select regions
in Europe and South America and is planning significant near-term commercial
expansion into Australia and additional European countries. Founded in 2003, GI
Dynamics is headquartered in Lexington, Massachusetts. For more information,
please visit www.gidynamics.com <http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.gidynamics.com&esheet=6868492&lan=en-US&anchor=www.gidynamics.com&index=4&md5=6a5a596a5fd73b5b55e4c24cce51c98e>
.
Forward-Looking Statements
This announcement contains or may contain forward-looking
statements that are based on management’s beliefs, assumptions and expectations
and on information currently available to management. All statements that
address operating performance, events or developments that we expect or
anticipate will occur in the future are forward-looking statements, including
without limitation our expectations with respect to our ability to commercialize
our EndoBarrier® including our estimates of potential revenues, costs,
profitability and financial performance; our ability to develop and
commercialize new products including our ability to obtain reimbursement for our
products; our expectations with respect to our clinical trials, including
enrolment in or completion of our clinical trials and our associated regulatory
submissions and approvals; our expectations with respect to the integrity or
capabilities of our intellectual property position. Management believes that
these forward-looking statements are reasonable as and when made. You should not
place undue reliance on forward-looking statements because they speak only as of
the date when made. GI Dynamics does not assume any obligation to publicly
update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise. GI Dynamics may not actually achieve
the plans, projections or expectations disclosed in forward-looking statements,
and actual results, developments or events could differ materially from those
disclosed in the forward-looking statements. Forward-looking statements are
subject to a number of risks and uncertainties, described in “Risk Factors” in
our Prospectus lodged with the Australian Securities & Investments Commission on
3 August 2011.
Contacts
Investor Enquiries:
United States:
Robert Crane, +1-781-357-3250
Chief Financial Officer
or
Australia:
Inteq Limited
David Allen / Alan Taylor, +61 2 9231 3322
or
Media Enquiries:
North America/Europe:
Pure Communications Inc.
Dan Budwick, + 1-973-271-6085
or
Australia:
Buchan Consulting Group
Rebecca Wilson, +61 3 9866 4722
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