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GI Dynamics Press Release - March 29, 2011

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New Data Show EndoBarrier® Triggers Beneficial Hormone Effects; Helps Patients Achieve Rapid Glycemic Control and Weight Loss while Reducing Heart Disease Risk Factors

Findings presented at 2nd World Congress on Interventional Therapies for Type 2 Diabetes support use as primary therapy for type 2 diabetes and obesity

New York and Lexington, Mass. – March 29, 2011 – GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, announced today new results from three studies that demonstrate the positive effects of the EndoBarrier® Gastrointestinal Liner on type 2 diabetes, weight loss and other metabolic factors. These data support the use of EndoBarrier as a primary therapy for the treatment of type 2 diabetes and obesity in patients with a body mass index (BMI) greater than 30 who have been unable to control their diabetes or lose weight through lifestyle changes and medications. Importantly, results from one study reveal for the first time the hormonal activity of EndoBarrier, which results in improved glycemic control and weight loss. These data and the benefits and role of EndoBarrier in type 2 diabetes were discussed during the session, “Novel Experimental Approaches for Diabetes/Obesity,” during the 2nd World Congress on Interventional Therapies for Type 2 Diabetes in New York.

Beneficial Hormonal Effects Result in Rapid and Long-lasting Improvement in Diabetes
Results were presented on the effects of EndoBarrier on two gastrointestinal hormones, gut peptides glucagon-like peptide-1 (GLP-1) and peptide YY (PYY), and other diabetes measures. The study, led by Professor Jan Willem Greve, M.D., Ph.D., Gastrointestinal and Bariatric Surgery, Atrium Medical Center, Parkstad Heerlen, The Netherlands, found that EndoBarrier treatment offered rapid and long-lasting improvement in diabetes, and for the first time, demonstrated beneficial hormonal effects similar to surgical interventions such as Roux-en-Y gastric bypass.

In the study, 17 obese patients with type 2 diabetes were implanted with the EndoBarrier for 24 weeks. Each patient was evaluated to assess levels of HbA1c, glucose, insulin, GLP-1 and PYY prior to, and at 24 weeks after implantation through blood draws conducted during meal tolerance tests using a 500 kcal test meal.

EndoBarrier treatment resulted in:

  • Rapid increase and sustained insulin sensitivity;
  • Increased levels of both PYY and GLP-1 after one-week implantation;
  • Mean excess weight loss of 29.8% and significant improvement in HbA1c of 1.4% (from 8.4% at baseline to 7.0%) in patients following six months of EndoBarrier use;
  • Reduction of anti-diabetic medications in 16/17 participants.

“These data reveal that EndoBarrier treatment affects key hormones involved in insulin sensitivity and satiety, which is likely the cause for the rapid improvement seen in type 2 diabetes,” said Dr. Greve. “This supports the belief that the EndoBarrier works by affecting hormone activation and that the device is a promising tool for the treatment of type 2 diabetes in obese individuals.”

Lee M. Kaplan, M.D., Ph.D., associate professor of medicine, Harvard Medical School; director, MGH Weight Center, Massachusetts General Hospital, Boston; and part of a panel discussion on novel approaches to diabetes and obesity at the 2nd World Congress, commented, “The findings from this study are striking. The EndoBarrier appears to affect the metabolic functions involved in type 2 diabetes through mechanisms similar to those that make bariatric surgery such an effective therapy for diabetes and obesity.”

Key Findings Support Role of EndoBarrier as Primary Therapy for Type 2 Diabetes and Obesity
Data from two clinical trials reported at the meeting indicate that the EndoBarrier may be a candidate for the primary therapy of type 2 diabetes and obesity. In one study, E.G.H.D. Moura, M.D., Ph.D., director of endoscopy, Hospital das Clinicas, University of São Paulo, evaluated use of the EndoBarrier in 22 patients with type 2 diabetes for one year.

After 12 months of EndoBarrier treatment, patients experienced:

  • Reduction in HbA1c levels from 8.9% at baseline to 6.6% (p<0.0001);
  • Decreased glucose levels from 175.6 at baseline to 137.8 mg/dL (p<0.0001);
  • Absolute weight loss of 20.2 kg (44 lbs.; p<0.0001), or 39% excess weight loss (p<0.0001).

Importantly, metabolic functions including levels of insulin, cholesterol, LDL and triglycerides were normalized at one year.

In another study, Alex Escalona, M.D., Department of Digestive Surgery, Pontificia Universidad Católica de Chile, Santiago, Chile, evaluated the effects of the EndoBarrier on weight loss and other cardiometabolic factors in 46 obese patients. At 12 months, the EndoBarrier treatment induced 20.0% total body weight loss (observed weight loss of 22.8 kg/50 lbs.), or 46.4% excess weight loss (p<0.0001).

The study also demonstrated that the EndoBarrier treatment improved key cardiometabolic risk factors, including:

  • Reduction in total cholesterol levels (195.0 mg/dL at baseline to 159.0 mg/dL; p<0.001);
  • Reduction in diastolic blood pressure (85 mmHg at baseline to 71 mmHg; p<0.001).

Data from a subset of six patients with type 2 diabetes achieved a mean reduction in HbA1c of 1.4 (p=0.05; 7.9% at baseline to 6.5%) following 12 months of treatment with the EndoBarrier.

Pharmaceutical treatments for type 2 diabetes often have diminishing benefits for patients despite more aggressive therapy. Surgical interventions, while effective, are associated with patient concerns about the risks of surgery and the irreversible aspects of some procedures. The EndoBarrier is a non-surgical, removable, physical barrier that enables food to bypass portions of the intestine, mimicking existing surgical interventions. This mechanism results in changes that “reset” the body’s metabolic functions to a more normalized state.

“There is a need for a type 2 diabetes and obesity therapy that provides effective, long-term results. Pharmaceutical regimens often cause weight gain in diabetes patients over time, while surgical interventions to obesity carry risks and complications that often concern patients,” said Dr. Escalona. “The EndoBarrier presents a unique solution to fill this treatment gap for type 2 diabetes and obesity. It has clinically proven rapid and long-lasting improvements in blood sugar control and weight loss, and offers physicians and patients an effective, non-surgical solution for the treatment of these diseases.”

About the 2nd World Congress on Interventional Therapies for Type 2 Diabetes
The 2nd World Congress on Interventional Therapies for Type 2 Diabetes is a comprehensive, multidisciplinary forum of worldwide specialists whose aim is to craft an agenda of research priorities and health policy initiatives and discuss how the study of gastrointestinal interventions may improve our understanding of diabetes and provide direction for future treatments of curative intent. It will offer a review of the data thus far and propose ways to improve patients' access to surgery when indicated. The 2nd World Congress builds significantly on insights gained at the 1st Congress, held in 2008. The 1st Congress was instrumental in raising awareness of the emerging discipline of metabolic surgery for diabetes and stimulated further research support by NIH, the ADA and other leading professional organizations.

About the EndoBarrier® Gastrointestinal Liner
The patented EndoBarrier Gastrointestinal Liner is a non-surgical medical device based on the EndoBarrier Technology platform for treating type 2 diabetes and obesity. The EndoBarrier Gastrointestinal Liner is approved for up to 12 months of use and is available in Europe and South American. It is an advanced investigational device in the United States. 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 preclinical and clinical evidence supports the potential for EndoBarrier Gastrointestinal Liner to change the treatment landscape for people living or having risk factors for: type 2 diabetes, obesity and severe weight problems.

About GI Dynamics
GI Dynamics is focused on developing effective, non-surgical therapeutics 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 may provide rapid improvement in glycemic control and significant weight loss by modifying metabolic pathways.

Based in Lexington, Mass. 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, Medtronic, Inc. and Polaris Venture Partners. For more information, visit GI Dynamics online at www.gidynamics.com.