Two New Centres of Excellence in Germany for EndoBarrier®

Abstract
US non-surgical obesity solutions company GI Dynamics, Inc. today announced that it has designated the Heart and Diabetes Centre North Rhine-Westphalia at Bad Oeynhausen and the Universitätsmedizin Mannheim as the newest Centres of Excellence (COEs) in Germany. 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.

Background

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.

“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.”

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.

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.

Clinician comments

“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.

“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.”

Company comments

“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.”

Regulatory status

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. The device is not approved for sale in the United States and is considered investigational.

Source: GI Dynamics