Data Published in Diabetes Technology and Therapeutics; EndoBarrier Shown to Rapidly Improve Glycemic Control, Enhance Weight Loss

LEXINGTON, Mass., November 11, 2009 – GI Dynamics, a leader in non-surgical treatments for type 2 diabetes and obesity, today announced data which demonstrate that obese patients with uncontrolled type 2 diabetes using the EndoBarrier™ Gastrointestinal Liner achieved near normalization of glycemic control in just one week, as compared to a sham control group. In addition, patients treated with EndoBarrier achieved a mean reduction of 2.4% in HbA1c glucose levels versus 0.8% for the sham arm at 24 weeks. Patients treated with EndoBarrier also achieved reductions in other diabetic factors including fasting blood glucose and weight. The results of the pilot study were published today in the current advance online issue of Diabetes Technology & Therapeutics.

“Studies show that every one percent decrease in HbA1c reduces health risks by 21 percent and as the rates of obesity and type 2 diabetes continue to reach epidemic proportions around the globe, patients are in urgent need of new therapeutic solutions that overcome the limitations associated with pharmaceutical regimens and invasive surgery,” stated Christopher Sorli, M.D., F.A.C.E., Department of Endocrinology, Billings Clinic, Billings, Montana and lead study author. “The results seen in the pilot study published today are significant because they underscore the promise of EndoBarrier as a non-surgical therapy that may offer immediate and sustained glycemic control in patients most at risk for developing serious complications due to their diabetes.”

The trial was designed to evaluate the EndoBarrier Gastrointestinal Liner for the treatment of type 2 diabetes; the single-blind, long-term study was conducted in 18 patients with type 2 diabetes who were prospectively randomized to receive either the EndoBarrier Gastrointestinal Liner (n=12) or a sham endoscopy (n=6). The primary endpoint in the trial was the reduction of HbA1c (average blood glucose level over three months) in patients who had a baseline HbA1c of 9.1 percent and BMI (body mass index) of 38.9.

Patients achieved the following results over a 24-week period, during which the device was implanted:

  • Patients treated with EndoBarrier achieved a mean reduction of 2.4% in HbA1c glucose levels versus 0.8% for the sham arm at 24 weeks;
  • Patients treated with EndoBarrier achieved a 55-point reduction in fasting blood glucose levels, another key indicator of diabetic status, versus a 42-point increase for the sham arm in one week;
  • Patients treated with EndoBarrier achieved a 20% decrease in the area under the glucose curve during a meal tolerance test at week one compared to a 17% increase in the sham arm.

Keith Gersin, M.D., FACS, Chief of Bariatric Surgery at Carolinas Medical Center, stated, “In clinical studies conducted to date with the EndoBarrier, patients have experienced immediate resolution of type 2 diabetes while the EndoBarrier is implanted, and continued resolution of their diabetes after the device is removed, as well as the important benefit of weight loss. These results are similar to those seen with gastric bypass surgery; however the EndoBarrier is implanted endoscopically during an incision-less, outpatient procedure. ”

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.

“GI Dynamics is pioneering a platform of non-surgical therapeutics that affect key metabolic pathways resulting in gastric bypass-like resolution of type 2 diabetes and significant weight loss,” said Stuart A. Randle, chief executive officer of GI Dynamics. “These data, published for the first time in Diabetes Technology and Therapeutics, further underscore the potential role that EndoBarrier may play in the lives of people battling type 2 diabetes and obesity, and the co-morbidities often associated with these challenging chronic diseases.”

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 preclinical 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.

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