Data from a Clinical Study Evaluating GI Dynamics` EndoBarrier to be Presented at IFSO

Wed Aug 26, 2009 8:30am EDT
 
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EndoBarrier  Gastrointestinal Liner Plus EndoBarrier Flow Restrictor
Dramatically Increases Weight Loss in Obese Patients; Compelling Impact on
Diabetes Risk Factors
PARIS--(Business Wire)--
GI Dynamics, a leader in non-surgical treatments for type 2 diabetes and
obesity, today announced that additional results from a previously reported
clinical study regarding mechanisms of action will be presented on Saturday,
August 29, 2009 by Manoel Galvao Neto, M.D., scientific coordinator, Gastro
Obeso Center, Sao Paulo, Brazil and lead investigator for the study, at the
International Federation for the Surgery of Obesity and Metabolic Disorders
(IFSO) 14th World Congress in Paris, France. 

This study, previously highlighted in June at the 26th annual meeting of the
American Society for Metabolic and Bariatric Surgery (ASMBS), demonstrated the
substantially enhanced weight loss benefits of combining the company`s
EndoBarrier Gastrointestinal Liner with a new EndoBarrier Flow Restrictor. The
EndoBarrier Flow Restrictor provides an adjustable restriction at the outlet of
the stomach and is designed to delay gastric emptying (GE), an additional
mechanism which adds to the therapeutic effects of the liner. The GE data being
reported at IFSO support this novel mechanism. 

"We have had significant clinical experience with the EndoBarrier at our obesity
management center, and even when assessed relative to invasive and other
noninvasive procedures, we believe the EndoBarrier platform represents a much
needed new approach to reducing weight and improving blood sugar control in
obese patients and patients at risk for serious metabolic disease," stated Dr.
Galvao. "In particular, we are excited about the new data emerging from our
ongoing clinical study in people living with type 2 diabetes and the notable
impact EndoBarrier appears to have on blood sugar control. We look forward to
sharing these data later this year upon completion of the trial." 

Stuart A. Randle, chief executive officer of GI Dynamics commented, "We are
seeing the clear need and desire for a non-surgical approach to treating type 2
diabetes while simultaneously addressing weight problems, especially in patients
with consistently difficult to manage blood sugar levels. Our growing clinical
experience with EndoBarrier suggests that this product and our platform are
uniquely suited to meet these challenges and provide a completely new way of
addressing the twin epidemics of type 2 diabetes and obesity." 

GI Dynamics is defining a new class of metabolic treatment options that fit
between pharmaceutical regimens and surgery, called non-surgical therapeutics.
Non-surgical therapeutics are designed to eliminate or reduce the risks and side
effects associated with pharmaceutical regimens as well as surgical options.
This new class of treatment can be performed easily and quickly without any
incisions, thus reducing patient anxiety and recuperative time. Unlike
traditional pharmaceutical approaches, non-surgical therapeutics remove the
burden of dose regimen compliance from the patient. Additionally, non-surgical
therapeutics hold the potential to improve the patient`s overall health, by
providing the control necessary to institute lifestyle and nutritional
improvements to maintain therapeutic effect, while being easily removed once the
desired effect has been attained and lifestyle changes implemented. Clinical
trials involving more than 250 patients have demonstrated the dramatic weight
loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal
Liner. 

About the EndoBarrier Gastrointestinal Liner

The patented EndoBarrier Gastrointestinal Liner is an advanced investigational,
non-surgical medical device based on the EndoBarrier Technology platform for
treating type 2 diabetes and obesity. The EndoBarrier Gastrointestinal Liner is
placed in the GI tract endoscopically (via the mouth) to create a barrier
between food and the wall of the intestine. Physicians believe that preventing
food from coming into contact with the intestinal wall may alter the activation
of hormonal signals that originate in the intestine, thus mimicking the effects
of a Roux-en-Y gastric bypass procedure without surgery. A growing body of
pre-clinical and clinical evidence supports the potential for EndoBarrier
Gastrointestinal Liner to dramatically change the treatment landscape for people
living with type 2 diabetes, obese people at risk for type 2 diabetes, and
people with severe weight problems. 

About GI Dynamics

GI Dynamics is focused on developing effective, non-surgical approaches for
treating type 2 diabetes and obesity. The company`s patented EndoBarrier
Technology has the potential to deliver medical interventions for people
combating weight problems and diabetes or diabetes risk factors. Data from
clinical trials demonstrate that the EndoBarrier Gastrointestinal Liner, an
advanced device in the EndoBarrier portfolio, may provide rapid improvement in
glycemic control and significant weight loss by modifying metabolic pathways. 

The company is also developing the EndoBarrier Flow Restrictor, which is
designed to further enhance the effectiveness of the liner by doubling the
amount of weight-loss that can be achieved using the liner alone. Each device in
the EndoBarrier portfolio is designed to assist patients gain control of their
blood sugar and achieve a healthier body mass index (BMI). GI Dynamics is
collaborating with experts in endocrinology, gastroenterology, bariatric surgery
and medical weight loss on these efforts. 

Based in Lexington, Massachusetts and founded in 2003, GI Dynamics is backed by
top-tier investors including Advanced Technology Ventures, Catalyst Health
Ventures, Cutlass Capital, Domain Associates, Johnson & Johnson Development
Corporation, and Polaris Venture Partners. For more information, visit GI
Dynamics online at www.gidynamics.com. 





Pure Communications Inc.
Caton Lovett, 910-232-7166
or
GI Dynamics
Jonathan Hartmann, 781-357-3300
jhartmann@gidynamics.com



Copyright Business Wire 2009

 

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