GI Dynamics' EndoBarrier non-surgical type 2 diabetes therapy receives European CE mark approval

Dec 22 2009

GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, today announced that it has received European CE mark approval for the EndoBarrier™, a non-surgical therapy to treat type 2 diabetes and obesity. The CE marking (an acronym for the French "Conformite Europeenne") certifies that a product has met EU requirements for marketing in Europe. Clinical trials involving more than 270 patients have demonstrated the significant weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner.

“This European approval for six months of EndoBarrier therapy to treat type 2 diabetes and obesity is another key milestone for GI Dynamics as we continue to prepare to launch the product in Europe”

“Based on the clinical results to date, we believe the EndoBarrier, as part of a multidisciplinary approach, has the potential to change the treatment paradigm for type 2 diabetes and weight problems,” stated Jan Willem Greve, M.D., Ph.D., Gastrointestinal and Bariatric Surgery, Atrium Medical Center Parkstad Heerlen, Netherlands. “Due to its unique profile as a non-surgical and non-pharmaceutical treatment option, the EndoBarrier appears to provide the benefits of gastric bypass surgery without the complications and risks associated with surgery. Unlike traditional pharmaceutical approaches, this implantable device removes the burden of dose regimen compliance from the patient. We look forward to having access to the EndoBarrier as a new treatment option in our fight against these epidemics.”

Type 2 diabetes affects an estimated 21 million Americans and 200 million people worldwide. According to the World Health Organization, type 2 diabetes comprises 90% of people with diabetes around the world, and is largely the result of excess body weight. Type 2 diabetes can lead to significant health problems including cardiovascular disease, retinopathy, neuropathy and nephropathy.

“This European approval for six months of EndoBarrier therapy to treat type 2 diabetes and obesity is another key milestone for GI Dynamics as we continue to prepare to launch the product in Europe,” said Stuart A. Randle, chief executive officer of GI Dynamics. “The growing body of clinical data demonstrates the EndoBarrier is well positioned to offer a meaningful, non-surgical approach to controlling diabetic factors and facilitating weight loss in patients suffering from the twin epidemics of type 2 diabetes and obesity. With European marketing approval in hand, we look forward to initiating our commercialization plans in Europe in the first half of 2010.”