GI Dynamics announced that it will present results of pilot clinical study of its EndoBarrier Gastrointestinal Liner in combination with a new EndoBarrier Flow Restrictor in morbidly obese patients at the 26th Annual Meeting of the American Society for Metabolic and Bariatric Surgery (ASMBS) in Grapevine, Texas.
The lead investigator for the pilot study Alex Escalona, M.D., Department of Digestive Surgery, Pontificia Universidad Católica de Chile, Santiago, Chile will deliver the presentation, entitled “Initial human experience with a restrictive, duodenal-jejunal bypass liner for the treatment of morbid obesity,” during the Emerging Technologies/Basic Research Session in Medical Specialties Track of ASMBS, on Friday, June 26. For the newly developed EndoBarrier Flow Restrictor combined with the EndoBarrier Gastrointestinal Liner this data represent the first clinical data. The EndoBarrier Flow Restrictor is designed to delay gastric emptying. It provides an adjustable restriction at the outlet of the stomach.
“GI Dynamics is pioneering 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,” stated Stuart A. Randle, chief executive officer of GI Dynamics. “Clinical trials involving more than 250 patients have demonstrated the dramatic weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner, and earlier this year compelling preclinical weight loss data for the EndoBarrier Flow Restrictor and liner combination were presented at SAGES. These new clinical data add to the growing body of data that show our EndoBarrier platform is a promising new therapeutic approach to treat patients with both type 2 diabetes and obesity.”
The preclinical trial was designed to assess weight gain limits offered by EndoBarrier Gastrointestinal Liner and EndoBarrier Flow Restrictor. The study revealed that the EndoBarrier Flow Restrictor limits weight gain in growing pigs to a similar degree as the EndoBarrier Gastrointestinal Liner. But in combination both the flow restrictor and the line provided twice the effect of decreased weight gain compared to either treatment alone.