Lexington, Massachusetts, United States and Sydney, Australia – March 8, 2012 – GI Dynamics, Inc. (ASX: GID) today announced that it has designated the Epworth Centre for Bariatric Surgery (ECBS) in Victoria as the first Center of Excellence (COE) for the EndoBarrier® Gastrointestinal Liner (the EndoBarrier) in Australia. It is expected that the first EndoBarrier patients in Australia will undergo treatment in the first half of this year.
The EndoBarrier, which received approval from the Therapeutic Goods Administration (TGA) last year for sale in Australia, is a thin, flexible, tube-shaped liner that forms a physical barrier between food and part 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 pressure and triglycerides, all of which contribute to the severity of type 2 diabetes
“We are delighted to designate the Epworth Centre for Bariatric Surgery as the first Center of Excellence to offer the EndoBarrier in Australia,” said Stuart A. Randle, GI Dynamics president and CEO. “Their highly-skilled, multidisciplinary team is well-suited to provide optimal EndoBarrier treatment for people living with type 2 diabetes and weight problems. Over the next several weeks we will complete our training efforts at ECBS, and they will then begin initiating patient screening and selection.”
The EndoBarrier is currently available in select markets in Europe and in Chile. A hospital is chosen to be a Center of Excellence based on its expertise in the treatment and management of type 2 diabetes and obesity and its support programs for patients undergoing treatment for these conditions. Clinical studies involving more than 500 patients have demonstrated that the EndoBarrier can help people living with type 2 diabetes and obesity achieve blood sugar control and significant weight loss.
“We are privileged to be the first Center to offer this innovative treatment option to patients in Australia as part of a comprehensive approach to diabetes and weight management,” said Dr. Harry Frydenberg, Director of the Epworth Centre for Bariatric Surgery, Victoria and former president of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO).
“Despite the pharmaceutical, surgical and lifestyle treatment options currently available, there are patients for whom these treatments are not fully effective,” continued Dr. Frydenberg. “The EndoBarrier offers us a completely new way to treat patients with the potential for substantial weight loss, improvement in diabetes and better overall health. We are pleased to be at the forefront of bringing new treatment options, like the EndoBarrier, to patients.” Diabetes is the sixth highest cause of death by disease for Australian men and women2.
The Australian Diabetes Council (ADC) has estimated that more than 3.5 million, or one in four, Australian adults have either diabetes or pre-diabetes, and that type 2 diabetes costs the country approximately A$3 billion a year. Globally, the International Diabetes Federation has estimated that approximately 320 million people have type 2 diabetes and that it accounts for approximately 90 percent of all cases of diabetes. The diagnosis of type 2 diabetes usually occurs after the age of 40 and is often, but not always, associated with obesity. For more information about the ECBS, please visit http://www.obesity.com.au/ or contact 1800 462373 to speak with a member of their patient management team. People interested in learning more about the EndoBarrier procedure and treatment should visit www.EndoBarrier.com.
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 and obese patients during the implant period. GI Dynamics currently markets the EndoBarrier in select regions in Europe and South America and is planning significant near-term commercial expansion into Australia and additional European countries. EndoBarrier is not approved for sale in the United States and is considered investigational. 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 enrolment 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.
Investor Enquiries:
United States
Robert Crane, Chief Financial Officer
+1 (781) 357-3250
Australia
David Allen / Alan Taylor, Inteq Limited
+61 2 9231 3322
Media Enquiries:
North America/Europe:
Dan Budwick, Pure Communications Inc.
+ 1 (973) 271-6085
Australia:
Rebecca Wilson, Buchan Consulting Group
+61 3 9866 4722
