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Data Show EndoBarrier® Therapy Demonstrates Glycemic Control in People with Type 2 Diabetes Who are Mildly Obese

— Results Published in Journal of Clinical Endocrinology & Metabolism Show EndoBarrier Effects in People with Type 2 Diabetes and Lower Body Mass Index —

LEXINGTON, Massachusetts & SYDNEY – January 31, 2013 — GI Dynamics, Inc. (ASX: GID) today announced the publication of clinical research in the Journal of Clinical Endocrinology & Metabolism demonstrating the effects of EndoBarrier® Therapy on blood glucose in patients with type 2 diabetes and mild obesity. The results of this study, previously presented at the annual meeting of the American Society for Metabolic & Bariatric Surgery, showed that EndoBarrier Therapy produced a statistically significant decrease in mean HbA1c and total cholesterol levels over a one-year period.

“These data demonstrate the powerful impact that EndoBarrier Therapy can have in helping people with type 2 diabetes achieve reduced HbA1c levels,” stated Ricardo V. Cohen, M.D., Center for the Surgical Treatment of Morbid Obesity and Metabolic Disorders, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil. “Diabetes is a challenging disease to effectively manage and there is a great need for new approaches to help patients achieve metabolic control. These findings suggest and support further consideration of EndoBarrier Therapy as an effective adjuvant treatment option for patients with type 2 diabetes and lower BMIs.”

In this open-label, single-center study, researchers evaluated one year of EndoBarrier Therapy in 20 patients with uncontrolled type 2 diabetes and a mean body mass index (BMI) of 30 kg (≥26 to ≤ 50 kg/m2). In the 16 patients that completed the one-year treatment period, the study findings show the following results:

• HbA1c levels of ≤ 7.0 achieved by 60 percent of study subjects at six months of treatment

• 10 out of 16 completer subjects (62.5 percent) achieved HbA1c levels of ≤ 7.0 percent

• A statistically mean decrease in HbA1c of 1.1 percent (from 8.6 percent at baseline to 7.5 percent; p=0.004)

• Mean fasting plasma glucose (FPG) changed from 207 ± 61 mg/dL at baseline to 139 ± 37 mg/dL one week after EndoBarrier implantation. At week 52, FPG was 155 ± 52 mg/dL in the 16 subjects who completed the study, representing a mean change from baseline of -45.8 ± 63.9 mg/dL (P = .012)

• Change in total cholesterol from 220 mg/dL at baseline to 188 mg/dL, and LDL from 135 mg/dL at baseline to 108 mg/dL

“We are pleased with the results from this initial study evaluating EndoBarrier Therapy use in people living with type 2 diabetes who have a lower BMI,” said Stuart A. Randle, president and CEO, GI Dynamics. “Our launch efforts in our current target market of obese people with type 2 diabetes are going very well, and we believe the lower BMI population represents an exciting market expansion opportunity going forward.”

About EndoBarrier

EndoBarrier enables functional bypass of the gastrointestinal tract (proximal small intestine) without surgery or permanent changes to the anatomy. This innovative and reversible procedure is believed to stimulate the secretion of GLP-1, which mediates glucose dependent insulin secretion, and PYY, which suppresses appetite and food intake, in the GI tract, leading to significant improvements in glycemic control and weight loss. [1] EndoBarrier is approved to treat type 2 diabetes and/or obesity in multiple countries outside of the United States and is considered an investigational device for the treatment of type 2 diabetes in the United States. For more information about EndoBarrier outside the United States, please visit www.EndoBarrier.com. For more information on the U.S. pivotal trial (the ENDO trial), please visit www.EndoBarrierTrial.com.

About Type 2 Diabetes and Obesity

Estimates indicate that type 2 diabetes affects more than 23 million people in the United States, [2] and approximately 320 million people worldwide. [3] 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.

About GI Dynamics

GI Dynamics, Inc. (ASX: GID) is the developer and marketer of EndoBarrier®, a breakthrough device that represents an entirely new class of non-surgical, non-pharmaceutical therapy for the treatment of type 2 diabetes and/or obesity. EndoBarrier is approved and commercially available in multiple countries outside the U.S.; and GI Dynamics is conducting a pivotal clinical trial of EndoBarrier in the U.S. for the treatment of patients who have uncontrolled type 2 diabetes and are obese. Founded in 2003, GI Dynamics is headquartered in Lexington, Massachusetts. For more information, please visit www.gidynamics.com. 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 enrollment 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.

[1] C de Jonge, JW Greve, N Bouvy, et al, “EndoBarrier Gastrointestinal Liner treatment rapidly improves diabetes parameters paralleled by increased postprandial GLP-1 and PYY levels in obese type 2 diabetic patients.” Department of Surgery, Maastricht University Medical Centre, presented at IFSO 2011, Hamburg, Germany.

 

[2] Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011.

[3] International Diabetes Federation, 5th edition of the Diabetes Atlas, 2011

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