LEXINGTON, Mass.--(BUSINESS WIRE)--GI Dynamics, Inc. (GI Dynamics), a company focused on the development and commercialization of effective, non-surgical approaches for the treatment of type 2 diabetes and obesity, today announced that the Australian Therapeutic Goods Administration (TGA) has approved the EndoBarrier® Gastrointestinal Liner (the EndoBarrier) for inclusion on the Australian Register of Therapeutic Goods (ARTG). The TGA has approved the use of the EndoBarrier for up to 12 months for the treatment of type 2 diabetes and obesity. With this approval, GI Dynamics will be able to commercially launch the EndoBarrier in Australia.
“Gaining approval to commercialize the EndoBarrier in Australia is another important milestone for our company,” said Stuart A. Randle, chief executive officer of GI Dynamics. “We look forward to working with Australian diabetes experts and leading centers to bring the EndoBarrier to market in this country.”
“There is an urgent need for less invasive, yet effective treatments for type 2 diabetes and obesity,” said Dr. Harry B. Frydenberg, director of the Epworth Centre for Bariatric Surgery, Victoria, Australia, and immediate past president of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). “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 Australians living with type 2 diabetes who are obese to control their diabetes and lose weight.”
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 Australian Diabetes Council (ADC) has estimated that more than 3 million, or one in four, Australian adults over the age of 25 have either diabetes or pre-diabetes, and that type 2 diabetes costs the country approximately A$3 billion a year.
About the EndoBarrier® Gastrointestinal Liner
The EndoBarrier is a new approach for the treatment of type 2 diabetes and obesity. The EndoBarrier is implanted non-surgically (through the mouth and without cutting any tissue) to create a barrier between food and the wall of the intestine. Clinical trials involving more than 500 patients have demonstrated that the EndoBarrier results in improved glycemic control and significant weight loss over the treatment period.
The EndoBarrier has already received CE mark approval in Europe for up to 12 months of treatment for type 2 diabetes and obesity. The EndoBarrier is commercially available in Chile, Germany, the United Kingdom and the Netherlands, and GI Dynamics has also received an investigational device exemption approval to commence a pilot trial of the EndoBarrier in the United States.
About GI Dynamics
GI Dynamics is focused on the development and commercialization of effective, non-surgical treatments for type 2 diabetes and obesity. The company’s patented EndoBarrier® technology has the potential to deliver effective treatments for people combating weight problems and diabetes or diabetes risk factors.
Based in Lexington, Mass., and founded in 2003, GI Dynamics’ investors include venture capital funds (ATV Associates, Polaris Venture Partners, Domain Associates and Cutlass Capital), a global medical device company, Medtronic, Inc. and a corporate strategic investor, Johnson & Johnson Development Corporation.