GI Dynamics to present additional results of mechanisms of actions clinical study

Aug 27 2009

GI Dynamics, a leader in non-surgical treatments for type 2 diabetes and obesity, today announced that additional results from a previously reported clinical study regarding mechanisms of action will be presented on Saturday, August 29, 2009 by Manoel Galvao Neto, M.D., scientific coordinator, Gastro Obeso Center, Sao Paulo, Brazil and lead investigator for the study, at the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) 14^th World Congress in Paris, France.

This study, previously highlighted in June at the 26^th annual meeting of the American Society for Metabolic and Bariatric Surgery (ASMBS), demonstrated the substantially enhanced weight loss benefits of combining the company’s EndoBarrier Gastrointestinal Liner with a new EndoBarrier Flow Restrictor. The EndoBarrier Flow Restrictor provides an adjustable restriction at the outlet of the stomach and is designed to delay gastric emptying (GE), an additional mechanism which adds to the therapeutic effects of the liner. The GE data being reported at IFSO support this novel mechanism.

“We have had significant clinical experience with the EndoBarrier at our obesity management center, and even when assessed relative to invasive and other noninvasive procedures, we believe the EndoBarrier platform represents a much needed new approach to reducing weight and improving blood sugar control in obese patients and patients at risk for serious metabolic disease,” stated Dr. Galvao. “In particular, we are excited about the new data emerging from our ongoing clinical study in people living with type 2 diabetes and the notable impact EndoBarrier appears to have on blood sugar control. We look forward to sharing these data later this year upon completion of the trial.”

Stuart A. Randle, chief executive officer of GI Dynamics commented, “We are seeing the clear need and desire for a non-surgical approach to treating type 2 diabetes while simultaneously addressing weight problems, especially in patients with consistently difficult to manage blood sugar levels. Our growing clinical experience with EndoBarrier suggests that this product and our platform are uniquely suited to meet these challenges and provide a completely new way of addressing the twin epidemics of type 2 diabetes and obesity.”

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. Clinical trials involving more than 250 patients have demonstrated the dramatic weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner.