14.12.2011 14:30:00
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GI Dynamics, Inc. Expands Availability of the EndoBarrier® Through Two New Centers of Excellence in Germany
GI Dynamics, Inc. (ASX: GID), a company pioneering the development of effective non-surgical approaches for treating type 2 diabetes and obesity, today announced that it has designated the Heart and Diabetes Center North Rhine-Westphalia at Bad Oeynhausen and the Universitätsmedizin Mannheim as the newest Centers of Excellence (COEs) in Germany. Together, they join Universitätsklinikum Hamburg-Eppendorf as the only COEs in Germany to currently offer the EndoBarrier® Gastrointestinal Liner (the EndoBarrier), a novel approach for the treatment of type 2 diabetes and/or obesity. A hospital is certified as an EndoBarrier COE after meeting initial qualifications of having a team experienced in treating patients with type 2 diabetes and obesity and following a rigorous training and proctorship program conducted by GI Dynamics.
"Type 2 diabetes and obesity are growing epidemics in Germany, throughout Europe and the rest of the world,” said Prof. Diethelm Tschöpe, medical director of the North Rhine-Westphalia Heart and Diabetes Centre in Bad Oeynhausen, Ruhr University in Bochum, Germany. "While diabetes is often treated with diet changes and medications, including insulin, we have found that many patients still struggle to improve their health and get their disease under control. The EndoBarrier fits inside a section of the intestine and helps patients lower their HbA1c levels and lose weight. In many cases, it has even helped patients reduce or eliminate their use of anti-diabetic medications. We are pleased to be among the first to provide this novel therapy to patients living in Germany to help them improve their diabetes and overall health.”
"We are delighted to designate Bad Oeyenhausen and Universitätsmedizin Mannheim as COEs for the EndoBarrier,” said Stuart A. Randle, president and chief executive officer of GI Dynamics. "Our initial commercialization strategy is focused on transitioning clinical centers to commercial centers. When establishing new COEs, we look for programs that have a strong medical team and take a multidisciplinary approach to weight loss and diabetes management. Bad Oeyenhausen and Universitätsmedizin Mannheim offer proven expertise in these areas and we will continue to work closely with them to assist in providing the best possible care to their patients seeking to gain control of their diabetes and weight with EndoBarrier. Germany is the largest single healthcare market in Europe, and expanding our presence here is an important milestone. We are very pleased that all three Centers are actively treating patients with EndoBarrier.”
In addition, GI Dynamics announced today that it has appointed Dirk Soeder to the newly created role of sales manager, Germany. In this position, Mr. Soeder will be responsible for overseeing the expansion of sales and marketing efforts for the EndoBarrier in Germany, including identifying and establishing new COEs, providing training and professional education to the COEs and working with existing Centers to ensure patient satisfaction.
"We are pleased to welcome Dirk to GI Dynamics,” said Mark C. Twyman, chief commercial officer at GI Dynamics. "The addition of Dirk to our commercial team will help ensure that our COEs receive the necessary training and guidance to achieve the best patient outcomes through use of the EndoBarrier. The experience and expertise that Dirk brings will be extremely valuable as we strive to make the EndoBarrier more broadly available to the physician and patient community in Germany.”
Mr. Soeder joins GI Dynamics with more than 15 years of sales experience and a strong track record of increasing profitability. Most recently, he served as senior sales manager for Johnson & Johnson Medical GmbH, Ethicon Endo Surgery Deutschland where he was responsible for the Endo-Surgery product division. Prior to that role, he spent several years with OBTECH Medical AG, where he was instrumental in bringing the Swedish adjustable gastric band to the German market.
Clinical studies involving more than 500 patients have demonstrated that the EndoBarrier can help type 2 diabetics and obese patients achieve diabetes control and significant weight loss through one solution. The EndoBarrier has been clinically proven to lower HbA1c levels, achieve weight loss of more than 20 percent, and improve other metabolic functions including cholesterol, blood sugar and triglycerides.
The EndoBarrier has received CE mark approval in Europe and TGA approval in Australia to treat type 2 diabetes and/or obesity for up to 12 months. The EndoBarrier is available through COEs in select European and South American markets. 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 support programs for patients undergoing treatment for these conditions.
The International Diabetes Federation has estimated that approximately 250 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.
People interested in learning more about the EndoBarrier procedure and treatment should visit www.EndoBarrier.com. Additional Centers of Excellence with access to the EndoBarrier can be found at www.EndoBarrier.com/find-doctor.
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 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 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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