LEXINGTON, Mass. & SYDNEY--(BUSINESS WIRE)--GI Dynamics, Inc. (ASX: GID) today announced that the first group of patients at the Epworth Centre for Bariatric Surgery (ECBS) in Australia have received treatment with EndoBarrier® Therapy. These patients were successfully implanted with the EndoBarrier at Epworth HealthCare in Melbourne.
“We are pleased to report that Dr. Harry Frydenberg and the highly-skilled team at ECBS have treated the first group of patients in Australia with EndoBarrier Therapy,” said Stuart A. Randle, GI Dynamics president and CEO. “This is an important milestone for our company and for clinicians and patients in Australia, who now have access to a new, non-surgical treatment option for type 2 diabetes and/or obesity.”
EndoBarrier is a breakthrough, endoscopic device that has been studied in 13 clinical trials and in more than 500 patients. It has been shown to lower HbA1c (blood glucose) levels, achieve weight loss of more than 20 percent and improve important metabolic functions including cholesterol, blood sugar and triglycerides within a year.1 The EndoBarrier received CE Mark approval for Europe in 2010, as well as approval by the Therapeutic Goods Administration in Australia in 2011 for the treatment of type 2 diabetes and/or obesity. It is currently commercially available in Australia, Chile and select markets in Europe.
"We are extremely pleased to have been able to make this innovative therapy available for the first time in Australia,” 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). “My expectation is that EndoBarrier Therapy may be the preferred treatment option for many more overweight diabetic patients in my practice."
The Australian Diabetes Council 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 EndoBarrier Therapy 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, South America and Australia, and is planning near-term commercial expansion into additional markets. The 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.
1 C de Jonge, JW Greve, N Bouvy, et al, EndoBarrier Gastrointestinal Liner treatment rapidly improves diabetes parameters paralleled by increased postprandial GLP-1 and PYY levels in obese type 2 diabetic patients, Department of Surgery, Maastricht University Medical Centre, presented at IFSO 2011, Hamburg, Germany.