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


EndoBarrier [TM] Gastrointestinal Liner Plus EndoBarrier Flow Restrictor Dramatically Increases Weight Loss in Obese Patients; Compelling Impact on Diabetes Risk Factors

PARIS Paris, in Greek mythology
Paris or Alexander, in Greek mythology, son of Priam and Hecuba and brother of Hector. Because it was prophesied that he would cause the destruction of Troy, Paris was abandoned on Mt.
 -- GI Dynamics, a leader in non-surgical treatments for type 2 diabetes type 2 diabetes
n.
See diabetes mellitus.
 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 Noun 1. metabolic disorder - a disorder or defect of metabolism
disorder, upset - a physical condition in which there is a disturbance of normal functioning; "the doctor prescribed some medicine for the disorder"; "everyone gets stomach upsets from time to time"
 (IFSO IFSO International Federation for the Surgery of Obesity ) 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 Bariatric Surgery Definition

Bariatric surgery promotes weight loss by changing the digestive system's anatomy, limiting the amount of food that can be eaten and digested.
 (ASMBS ASMBS American Society for Metabolic and Bariatric Surgery ), 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 metabolic disease,
n a disorder that causes dysfunction of the metabolic action of the body, resulting in loss of control of homeostasis.

paraneoplastic syndrome 
," 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 Side effects

Effects of a proposed project on other parts of the firm.
 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 re·cu·per·ate  
v. re·cu·per·at·ed, re·cu·per·at·ing, re·cu·per·ates

v.intr.
1. To return to health or strength; recover.

2. To recover from financial loss.

v.tr.
 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[TM] 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 Verb 1. originate in - come from
stem - grow out of, have roots in, originate in; "The increase in the national debt stems from the last war"
 the intestine, thus mimicking the effects of a Roux-en-Y gastric bypass Roux-en-Y gastric bypass
n.
A Y-shaped surgical connection that divides the small intestine and connects one end to the stomach, bile duct, or other structure and connects the opposite end to the small intestine at a point below the first connection.
 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[TM] 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[TM] Gastrointestinal Liner, an advanced device in the EndoBarrier portfolio, may provide rapid improvement in glycemic Glycemic
The presence of glucose in the blood.

Mentioned in: Cholesterol, High


glycemic

pertaining to the level of glucose in the blood.
 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 BMI body mass index.

BMI
abbr.
body mass index


Body mass index (BMI)
A measurement that has replaced weight as the preferred determinant of obesity.
). GI Dynamics is collaborating with experts in endocrinology, gastroenterology gastroenterology

Medical specialty dealing with digestion and the digestive system. In the 17th century Jan Baptista van Helmont conducted the first scientific studies in the field; William Beaumont published his own observations in 1833.
, bariatric surgery and medical weight loss on these efforts.

Based in Lexington, Massachusetts Lexington is a town in Middlesex County, Massachusetts, United States. The population was 30,355 at the 2000 census.

The town is famous for being the site of the opening shots of the Battles of Lexington and Concord, the first engagement of the American Revolution.
 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.
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Publication:Business Wire
Article Type:Clinical report
Date:Aug 26, 2009
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