GI Dynamics, Inc. Announces Commercial Availability of the EndoBarrier® for the Treatment of Type 2 Diabetes and/or Obesity in the Netherlands

LEXINGTON, Mass. & SYDNEY--()--GI Dynamics, Inc. (ASX: GID) today announced the transition of the EndoBarrier® Gastrointestinal Liner (the EndoBarrier), a novel, non-surgical device for the treatment of type 2 diabetes and/or obesity, from clinical research to commercial use in the Netherlands. To date, nearly 100 patients have been treated with the EndoBarrier in clinical trials conducted in the Netherlands.

“We have studied the EndoBarrier for several years and are very happy with the improvements in blood sugar and weight loss our patients have achieved,” said Ignace Janssen, M.D., clinical study investigator and bariatric surgeon, Vitalys Obesitas Centrum, Rijnstate Hospital, Arnhem, Netherlands. “Our clinical experience has given us a keen understanding of the type 2 diabetes patients and/or obese patients who would be good candidates for EndoBarrier therapy. Additionally, it has helped us develop the optimal treatment program that will help ensure successful outcomes for our patients.”

Martin Kirch, director of Vitalys Clinics added, “The EndoBarrier is filling a gap in our treatment paradigm. In particular, we believe it can help obese diabetic patients in the lower BMI range. The EndoBarrier provides an approach to better manage type 2 diabetes and related comorbidities for these patients.”

The EndoBarrier has received European CE mark approval and is commercially available in Chile, Germany, the United Kingdom, the Netherlands and Austria. The EndoBarrier has also received TGA approval and will soon be available in Australia.

“We are delighted that the EndoBarrier is now being offered commercially through this Center of Excellence in the Netherlands,” said Stuart A. Randle, president and chief executive officer, GI Dynamics. “In particular, the success this center has had implanting the EndoBarrier under conscious sedation is very exciting and could potentially translate into reduced costs and even more rapid recovery. These are important milestones for the company as we expand from clinical to commercial use in key European markets.”

The EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. It has been clinically proven to lower HbA1c levels, achieve weight loss of more than 20 percent and improve other important metabolic functions including cholesterol, blood sugar and triglycerides.

Clinical trials conducted in the Netherlands have been critical to understanding the effects of the EndoBarrier. Findings from one study presented at the 47th Annual Meeting of the European Association for the Study of Diabetes revealed that the EndoBarrier affects certain gastrointestinal hormones involved in insulin sensitivity, glucose metabolism and satiety, and that these changes allow for rapid and sustained improvement of type 2 diabetes.

In the Netherlands, it is estimated that there were more than 800,000 people living with type 2 diabetes in 2010, and that number is expected to increase to nearly 1.1 million by 20201. The International Diabetes Federation has estimated that approximately 320 million people have type 2 diabetes worldwide. 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 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 patients and/or obese patients during the implant period. GI Dynamics currently markets the EndoBarrier in select regions in Europe and South America and is planning 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.

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 Booz & Company, “Diabetes Care in the Netherlands: Improving Health and Wealth,” 14 November 2011

Contacts

Investor Enquiries:
United States
Robert Crane, Chief Financial Officer
+1-781-357-3250
or
Australia
David Allen / Alan Taylor, Inteq Limited
+61 2 9231 3322
or
Media Enquiries:
North America/Europe:
Dan Budwick, Pure Communications Inc.
+ 1 (973) 271-6085
or
Australia:
Rebecca Wilson, Buchan Consulting Group
+61 3 9866 4722

Contacts

Investor Enquiries:
United States
Robert Crane, Chief Financial Officer
+1-781-357-3250
or
Australia
David Allen / Alan Taylor, Inteq Limited
+61 2 9231 3322
or
Media Enquiries:
North America/Europe:
Dan Budwick, Pure Communications Inc.
+ 1 (973) 271-6085
or
Australia:
Rebecca Wilson, Buchan Consulting Group
+61 3 9866 4722