New Clinical Data on GI Dynamics’ EndoBarrier™ Flow Restrictor to be Presented at the 26th Annual Meeting of the American Society for Metabolic and Bariatric Surgery

LEXINGTON, Mass.--(BUSINESS WIRE)--GI Dynamics, a leader in non-surgical treatments for type 2 diabetes and obesity, today announced that results from a pilot clinical study of the company’s EndoBarrier Gastrointestinal Liner in combination with a new EndoBarrier Flow Restrictor in morbidly obese patients will be presented at the 26^th Annual Meeting of the American Society for Metabolic and Bariatric Surgery (ASMBS) in Grapevine, Texas.

“Initial human experience with a restrictive, duodenal-jejunal bypass liner for the treatment of morbid obesity”

The presentation, entitled “Initial human experience with a restrictive, duodenal-jejunal bypass liner for the treatment of morbid obesity,” will be delivered by Alex Escalona, M.D., Department of Digestive Surgery, Pontificia Universidad Católica de Chile, Santiago, Chile and lead investigator for the pilot study, during the Emerging Technologies/Basic Research Session in the Medical Specialties Track of ASMBS, on Friday, June 26 at 8:20 a.m. (CDT). These data represent the first clinical data for the newly developed EndoBarrier Flow Restrictor combined with the EndoBarrier Gastrointestinal Liner. The EndoBarrier Flow Restrictor provides an adjustable restriction at the outlet of the stomach and is designed to delay gastric emptying, an additional mechanism which adds to the therapeutic effects of the liner.

“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 study presented at SAGES was designed to assess the effects on body weight in a porcine model of the EndoBarrier Flow Restrictor alone and in combination with the EndoBarrier Gastrointestinal Liner. Preclinical findings demonstrated that treatment with the EndoBarrier Flow Restrictor limits weight gain in growing pigs to a similar degree as the EndoBarrier Gastrointestinal Liner, but when combined, both the liner and the flow restrictor resulted in approximately twice the effect of decreased weight gain compared to either treatment alone.

For more information on GI Dynamics and the EndoBarrier, please visit booth #1017 during ASMBS.

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 dramatically 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.

About GI Dynamics

GI Dynamics is focused on developing effective, non-surgical approaches for treating type 2 diabetes and obesity. The company’s patented EndoBarrier™ Technology has the potential to deliver medical interventions for people combating weight problems and diabetes or diabetes risk factors. Data from clinical trials demonstrate that the EndoBarrier™ Gastrointestinal Liner, an advanced device in the EndoBarrier portfolio, may provide rapid improvement in glycemic control and significant weight loss by modifying metabolic pathways.

The company is also developing the EndoBarrier Flow Restrictor, which is designed to further enhance the effectiveness of the liner by doubling the amount of weight-loss that can be achieved using the liner alone. Each device in the EndoBarrier portfolio is designed to assist patients gain control of their blood sugar and achieve a healthier body mass index (BMI). GI Dynamics is collaborating with experts in endocrinology, gastroenterology, bariatric surgery and medical weight loss on these efforts.

Based in Lexington, Massachusetts and founded in 2003, GI Dynamics is backed by top-tier investors including Advanced Technology Ventures, Catalyst Health Ventures, Cutlass Capital, Domain Associates, Johnson & Johnson Development Corporation, and Polaris Venture Partners. For more information, visit GI Dynamics online at www.gidynamics.com.