GI Dynamics` EndoBarrier Gastrointestinal Liner Demonstrates Safety and Efficacy in Pre-surgical Weight Loss

Study Shows Resolution of Type 2 Diabetes in Morbidly Obese Patients; Data
Published in Annals of Surgery
LEXINGTON, Mass.--(Business Wire)--
GI Dynamics, a leader in non-surgical treatments for type 2 diabetes and
obesity, today announced data which support the safety and efficacy of the
EndoBarrier Gastrointestinal Liner for pre-surgical weight loss treatment, along
with a positive effect on glucose homeostasis in morbidly obese patients with
type 2 diabetes mellitus.

According to the study, mean excess weight loss (EWL) achieved after 12 weeks
post implantation was 19.0 % for EndoBarrier patients versus 6.9 % for control
patients (p<0.002). The results of this European weight loss study were
published today in the advance online publication of Annals of Surgery.

"As worldwide incidence of obesity has nearly doubled, and more than 200 million
people worldwide suffer from type 2 diabetes, there is an increasing and
significant unmet need for safe and effective non-surgical treatment options for
these twin epidemics," stated Jan Willem Greve, M.D., Ph.D., Gastrointestinal
and Bariatric Surgery, Atrium Medical Center Parkstad Heerlen, Netherlands, and
study co-author. "These data published in Annals of Surgery reflect the first
European experience with the EndoBarrier, and also reinforce the promising
weight loss data seen in clinical studies with the EndoBarrier to date."

The clinical trial was designed to examine the safety and efficacy of the
EndoBarrier in morbidly obese patients. In a multi-center, randomized clinical
trial, 41 patients were enrolled and 37 patients were treated. Twenty-six
patients received the EndoBarrier and 11 were in the diet control group. The
EndoBarrier was implanted for 12 weeks. Three patients kept the device implanted
for 24 weeks. Patients in both the EndoBarrier and diet control groups followed
the same diet during the study period. Starting average weight for these two
groups was similar with 142.5 kg (314.2 lbs) for EndoBarrier patients versus
137.5 kg (303.2 lbs) for control group patients, and body mass index (BMI) of
48.9 versus 49.2, respectively.

Mean excess weight loss (EWL) achieved after 12 weeks was 19.0 % for EndoBarrier
patients versus 6.9 % for control patients (p<0.002). In the 3 patients that
kept the EndoBarrier implanted for 24 weeks, the EWL was 24.3%. Absolute change
in BMI at 12 weeks was 5.5 and 1.9 kg/m2, respectively. Type 2 Diabetes mellitus
was present at baseline in 8 patients of the device group and improved in 7
patients during the 12 week study period (lower glucose levels, HbA1c and
medication requirements). Notably, 6 out of 8 patients in the device group
decreased insulin dosages and/or oral anti-diabetic medication after one week.
At 12 weeks, there was still an ongoing improvement in 5 patients (continuous
lowering of medication requirements), and 1 patient was able to completely stop
diabetes medication.

"These promising data in morbidly obese patients reinforce the potential of
EndoBarrier as an innovative, non-surgical therapeutic for patients battling
obesity and type 2 diabetes," said Stuart A. Randle, chief executive officer of
GI Dynamics. "This was the first European clinical weight loss study conducted
with the EndoBarrier, and since then the EndoBarrier has been successfully
implanted in more than 250 patients. As GI Dynamics has expanded the clinical
development program for EndoBarrier in patients with obesity and type 2
diabetes, we have continued to see impressive results, and have been able to
continuously refine our device and improve the implantation 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.

The full study can be accessed online at
http://journals.lww.com/annalsofsurgery/toc/publishahead, and will also be
published in an upcoming print issue of Annals of Surgery.

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.

Pure Communications Inc.
Caton Lovett, 910-232-7166
or
GI Dynamics
Jonathan Hartmann, 781-357-3300, jhartmann@gidynamics.com

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