Weight Loss Data for EndoBarrier™ Technology Platform Presented at the Society of American Gastrointestinal and Endoscopic Surgeons 2009 Annual Meeting (SAGES)

LEXINGTON, Mass.--(BUSINESS WIRE)--GI Dynamics, a leader in non-surgical, endoscopic approaches for treating type 2 diabetes and obesity, today announced the presentation of new preclinical data for its EndoBarrier™ Technology. The study highlights the enhanced weight loss effects of combining the 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.

“We are very pleased with the results seen in this study and the increased effect on weight loss seen with usage of both the EndoBarrier Gastrointestinal Liner and the EndoBarrier Flow Restrictor”

Previous studies have demonstrated the dramatic weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner. This latest data suggest that the combination of the EndoBarrier Gastrointestinal Liner with the EndoBarrier Flow Restrictor could enhance the effectiveness of the liner by nearly doubling the amount of weight-loss achieved by using the liner alone. These preclinical data were presented by study investigator Keith Gersin, M.D., FACS, Chief of Bariatric Surgery at Carolinas Medical Center, and a member of GI Dynamics’ Scientific Advisory Board, during the Emerging Technology Session at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2009 Annual Meeting in Phoenix, Arizona, on April 25, 2009 at 9:30 a.m. (MST).

“These findings support what we have seen to date in other preclinical studies with both devices individually, confirming that combining the EndoBarrier Gastrointestinal Liner with the EndoBarrier Flow Restrictor have an enhanced effect on weight loss,” said Dr. Gersin. “In clinical studies of the EndoBarrier alone, we have seen a substantial effect on weight loss and resolution of type 2 diabetes, and we anticipate we will see enhanced weight loss with the combination of these two devices in human clinical trials.”

“We are very pleased with the results seen in this study and the increased effect on weight loss seen with usage of both the EndoBarrier Gastrointestinal Liner and the EndoBarrier Flow Restrictor,” said Stuart A. Randle, chief executive officer of GI Dynamics. “We believe that the combination of these two devices impacts weight loss through distinct mechanisms of action and may truly represent a breakthrough in treating type 2 diabetes and obesity. GI Dynamics is conducting ongoing clinical studies investigating the synergistic effects of the combined devices and we look forward to sharing these results at an upcoming medical meeting later this year.”

Overview of Preclinical Study Findings

The preclinical study was designed to assess the effects on body weight in a porcine (pig) model of the EndoBarrier Flow Restrictor alone and in combination with the EndoBarrier Gastrointestinal Liner. In this study, the restrictor, with hole sizes ranging from 3 to 7 millimeters (mm) in diameter, was implanted endoscopically in the duodenum (first part of the small intestine) of the animals with a mean starting weight of 40.6±7.4 kilograms (kg). The modified device restricted the flow of partially digested food in the duodenum. For comparison, a control group underwent sham (control) endoscopic procedure. The animals were monitored for weight gain for up to 90 days and researchers evaluated daily general health and weekly weight of each animal and conducted monthly evaluations of the position and patency of the liner through fluoroscopy and endoscopy. In a separate experiment, the animals received either a 4 mm diameter restrictor device, the EndoBarrier Gastrointestinal Liner or a combination of the liner and the 4 mm restrictor.

The findings demonstrate 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 on body weight compared to either treatment alone. The combination of the EndoBarrier Gastrointestinal Liner and the EndoBarrier Flow Restrictor with a 4 mm opening decreased weight gain to 0.16 ± 0.106 kg/day. This is significantly less than the decreased weight gain seen in the sham treatment group, which gained an average 0.41 ± 0.021 kg/day, and in the groups implanted with the EndoBarrier Flow Restrictors with openings of either 5 or 7 mm, which gained weight at the same rate (0.47 ± 0.026 kg/day and 0.42 ± 0.017 kg/day, respectively). The group implanted with the EndoBarrier Flow Restrictor with a 4 mm opening had a weight gain of 0.31 ± 0.014 kg/day which is significantly less weight gain compared to the sham treatment group (p=0.03) and similar to the standard, unmodified EndoBarrier Gastrointestinal Liner (0.26 ± 0.025 kg/day).

About the EndoBarrier™ Gastrointestinal Liner

GI Dynamics is developing the EndoBarrier Gastrointestinal Liner, an innovative, endoscopic and removable device, which is considered investigational and not yet commercially available. The EndoBarrier is currently being studied in clinical trials around the world as a potential treatment for patients with both type 2 diabetes and obesity.

The EndoBarrier creates a physical barrier that lines the intestine to keep food from coming in contact with the intestinal wall. Physicians believe this may alter the activation of hormonal signals that originate in the intestine, and may mimic the effects of a Roux-en-Y gastric bypass procedure. However, the EndoBarrier procedure is done without the risks associated with highly invasive surgical procedures. The EndoBarrier is placed and removed endoscopically (via the mouth) without the need for surgical intervention or alteration of the patient’s anatomy.

The EndoBarrier Gastrointestinal Liner in combination with the EndoBarrier Flow Restrictor can be customized to meet individual patient needs. Significant preclinical studies have confirmed that combining these two devices affects multiple mechanisms of action and enhances weight loss.

About GI Dynamics

GI Dynamics is a clinical-stage medical device company pioneering the development of devices that influence multiple metabolic pathways to improve glycemic control in patients with type 2 diabetes and achieve weight loss in obese patients. The Company’s patented EndoBarrier™ Technology has the potential to deliver immediate metabolic control by modifying metabolic pathways.

GI Dynamics is developing the EndoBarrier, a platform of endoscopic, removable devices that line a portion of the small intestine, mimicking the effects of Roux-en-Y gastric bypass surgery without the risks associated with highly invasive surgical procedures. Clinical trials are ongoing to evaluate longer-term clinical benefit of the EndoBarrier for the treatment of type 2 diabetes and obesity.

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.