New Type 2 Diabetes And Obesity Treatment Approved - EndoBarrier Receives European CE Mark

Main Category: Diabetes
Also Included In: Obesity / Weight Loss / Fitness;  GastroIntestinal / Gastroenterology;  Regulatory Affairs / Drug Approvals
Article Date: 26 Dec 2009 - 0:00 PDT

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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.

"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."

GI Dynamics is defining a new class of metabolic treatment options that fit between pharmaceutical regimens and surgery, called non-surgical therapeutics. Non-surgical therapeutics are designed to eliminate or reduce the risks and side effects associated with pharmaceutical regimens as well as surgical options. This new class of treatment can be performed easily and quickly without any incisions, thus reducing patient anxiety and recuperative time. Unlike traditional pharmaceutical approaches, non-surgical therapeutics remove the burden of dose regimen compliance from the patient. Additionally, non-surgical therapeutics hold the potential to improve the patient's overall health, by providing the control necessary to institute lifestyle and nutritional improvements to maintain therapeutic effect, while being easily removed once the desired effect has been attained and lifestyle changes implemented.

About the EndoBarrier™ Gastrointestinal Liner

The patented EndoBarrier Gastrointestinal Liner is an advanced investigational, non-surgical medical device based on the EndoBarrier Technology platform for treating type 2 diabetes and obesity. The EndoBarrier Gastrointestinal Liner is placed in the GI tract endoscopically (via the mouth) to create a barrier between food and the wall of the intestine. Physicians believe that preventing food from coming into contact with the intestinal wall may alter the activation of hormonal signals that originate in the intestine, thus mimicking the effects of a Roux-en-Y gastric bypass procedure without surgery. A growing body of pre-clinical and clinical evidence supports the potential for EndoBarrier Gastrointestinal Liner to change the treatment landscape for people living with type 2 diabetes, obese people at risk for type 2 diabetes, and people with severe weight problems.

Source
GI Dynamics

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