Lexington, Massachusetts, and Sydney, Australia – July 17, 2012 – GI Dynamics, Inc. (ASX: GID) has continued to strengthen its global commercial foundation and footprint for EndoBarrier® Therapy, a breakthrough treatment for type 2 diabetes and/or obesity. The company today announced an update on its progress toward key commercialization goals and recent activities in both new and existing markets, including expanded availability of EndoBarrier in Germany, performance of the first EndoBarrier Therapy procedures in France, designation of the first Center of Excellence in Chile and the addition of two commercial centers in Chile.
“We are pleased with our progress in introducing EndoBarrier into new markets and expanding and designating additional treatment centers in existing commercial markets, which are two of the key objectives we set for 2012,” said Mark C. Twyman, chief commercial officer of GI Dynamics. “We are working with some of the most prominent diabetes and obesity physicians at leading centers around the world and they all see the clear need for better options to treat these chronic diseases. We are beginning to achieve a paradigm shift in the understanding and execution of type 2 diabetes and obesity treatment as we continue our efforts to broaden and deepen our global commercial footprint for EndoBarrier.”
Recent global achievements include:
• Expansion of commercial centers in Germany including University Hospital Schleswig-Holstein, Campus Lübeck, led by Professor Morten Schütt, head of the diabetes and metabolism department.
• Treatment of the first patients with EndoBarrier Therapy in France at University Hospital Lille Hôpital Claude Huriez, led by Professor François Pattou, professor of general surgery and head, department of general and endocrine surgery.
• Designation of Red Salud UC as the first EndoBarrier Therapy Center of Excellence in Santiago, Chile. Led by Alex Escalona, M.D., one of the most experienced practitioners of EndoBarrier Therapy in the world, he and his team have treated more than 200 patients with EndoBarrier to date.
• Expansion of the availability of EndoBarrier Therapy in Chile at Clinica Indisa and Clinica Reñaca where the first commercial patients have now been treated, led by another experienced EndoBarrier expert, Leonardo Rodriguez, M.D.
“EndoBarrier Therapy is becoming a valuable treatment option for our Center, particularly for those patients whose type 2 diabetes and obesity cannot be well controlled with medications or lifestyle changes,” stated Professor Schütt. “Germany, unfortunately, has one of the highest rates of diabetes prevalence and diabetes mortality in the EU, so new treatment options that address and improve this disease are very much needed.”
“We are excited to be able to offer EndoBarrier Therapy to a pilot series of patients in France,” said Professor Pattou. “Type 2 diabetes incidence is increasing in France and roughly 14.5 percent of the adult population is now obese, so we are pleased to offer these patients an alternative solution that will enable them to lose weight, get their blood sugar under control and improve their overall health.”
Clinical studies of EndoBarrier Therapy have shown that more than 80 percent of obese patients are able to reach their target blood sugar levels (HbA1c < 7) and lose an average 20 percent of their total body weight in one year, , , which may lead to a reduction in diabetes-related complications.
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, 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, South America and Australia and is planning near-term commercial expansion into 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.
About EndoBarrier Therapy
EndoBarrier Therapy is a breakthrough treatment for type 2 diabetes and/or obesity that has been clinically demonstrated to lower HbA1c levels, achieve weight loss of approximately 20 percent, and improve important metabolic measures including cholesterol, blood pressure and triglycerides.1,2 It has been studied in 13 clinical trials and has been used in more than 500 patients. The EndoBarrier device is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. EndoBarrier Therapy affects certain gastrointestinal hormones involved in insulin sensitivity, glucose metabolism and satiety, and these changes allow for rapid and sustained improvement of type 2 diabetes and weight loss.
For more information, please visit www.endobarrier.com
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.
Robert Crane, Chief Financial Officer
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Rebecca Wilson, Buchan Consulting Group
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