Company Treats First Patients with the EndoBarrier and Establishes Centers of Excellence in Austria; Distribution Agreement for the EndoBarrier in Austria
LEXINGTON, Mass. & SYDNEY–(BUSINESS WIRE)–GI Dynamics, Inc. (ASX: GID) today announced the launch of the EndoBarrier® Gastrointestinal Liner (the EndoBarrier) in Austria, the establishment of the first two Centers of Excellence and the treatment of patients at each new Center.
The Barmherzige Brüder Hospital and the Hallein Clinic are the first Centers of Excellence established by GI Dynamics in Austria. Both centers are very experienced in the field of metabolic disorders and are well known for their publications in the field. All EndoBarriers used in the procedures were either paid for by the hospital or by the patients.
Austria has a significant type 2 diabetic population, estimated by the World Health Organization to be more than 600,000 adult patients and an obese population (Body Mass Index greater than 30) of nearly 700,000 adult patients. As in the rest of the world, both type 2 diabetes and obesity are increasing rapidly in Austria.
“There is an urgent need for less invasive, yet effective treatments for type 2 diabetes and obesity,” said Helmut G. Weiss, M.D., M.Sc., associate professor of surgery and head of the general surgery department at Barmherzige Brüder Hospital. “We see many patients for whom existing pharmaceutical and lifestyle treatments are not effective in helping them manage their blood sugar levels or produce the weight loss they need. The EndoBarrier has the potential to assist many Austrians living with type 2 diabetes and obesity control their diabetes and lose weight.”
“Through one therapeutic approach, the EndoBarrier can help people control their glucose levels and lose weight at the same time,” said Karl A. Miller, M.D., FACS, associate professor of surgery, head of the surgical department at Hallein Clinic and president of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). “We are delighted to be a Center of Excellence and to offer the EndoBarrier therapy to our patients.”
The EndoBarrier Centers of Excellence are recognized for their expertise in the treatment and management of type 2 diabetes and obesity, and support programs for patients undergoing treatment for these conditions. A hospital is certified as an EndoBarrier Center of Excellence following a rigorous training and proctorship program conducted by GI Dynamics in collaboration with global experts in type 2 diabetes and obesity management.
In addition, GI Dynamics announced it has entered into an agreement with D/A/CH Medical Group, for the distribution of the EndoBarrier in Austria. The agreement provides D/A/CH Medical Group the rights to sell and distribute the EndoBarrier within this territory subject to certain minimums and other provisions.
“We are pleased to designate Barmherzige Brüder and Hallein Clinic as Centers of Excellence and to be working with D/A/CH Medical Group to make the EndoBarrier broadly available to the physician and patient community in Austria,” stated Stuart A. Randle, chief executive officer of GI Dynamics. “At the same time, we look forward to expanding the availability of the EndoBarrier to additional Centers of Excellence in Europe, Australia and the Pacific Rim, and South America.”
Results from clinical studies involving more than 500 patients have demonstrated that treatment with the EndoBarrier may significantly improve patients’ HbA1c (glucose) levels, enable substantial weight loss, and improve other metabolic functions including cholesterol, blood sugar and triglycerides.
The EndoBarrier has received CE mark approval in Europe for periods of up to 12 months of treatment for type 2 diabetes and obesity. The EndoBarrier is inserted in a procedure that generally takes less than 30 minutes and it remains in the body for up to 12 months. It can be easily removed in a non-surgical procedure of approximately 15 minutes.
In addition to Austria, the EndoBarrier is currently commercially available through Centers of Excellence in Chile, Germany, the United Kingdom and the Netherlands, and recently received TGA approval in Australia. GI Dynamics also received an investigational device exemption approval to commence a pilot trial of the EndoBarrier in the U.S.
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. The International Diabetes Federation has estimated that approximately 250 million people have type 2 diabetes worldwide.
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. Founded in 2003, GI Dynamics is headquartered in Lexington, Massachusetts. For more information, please visit www.gidynamics.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 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.
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