GI Dynamics Announces First Clinical Study to Demonstrate Improvement in Weight Loss and Co-morbid Conditions Following

  GI Dynamics Announces First Clinical Study to Demonstrate Improvement in
  Weight Loss and Co-morbid Conditions Following EndoBarrier® Re-implantation

  Data Presented at UEGW Show Patients Successfully Treated with EndoBarrier
 Therapy Can be Safely Re-implanted and Achieve Additional Clinical Benefits

20th United European Gastroenterology Week (UEGW)

Business Wire

LEXINGTON, Mass. & AMSTERDAM -- October 22, 2012

GI Dynamics, Inc. (ASX: GID) today announced the first study evaluating the
long-term benefits and safety of re-implanting EndoBarrier^® to extend weight
loss benefits for three years. Data suggest EndoBarrier may be re-implanted
approximately one year after completion of the initial treatment period, which
may help obese people experience additional weight loss, long-term weight loss
maintenance and improvement in other co-morbid conditions, including
cholesterol, blood pressure and fasting blood glucose (FPG), a key measure of
blood sugar levels used to diagnose diabetes.

The study findings, which were presented during the 20^th United European
Gastroenterology Week (UEGW), support earlier evidence that EndoBarrier
provides sustained weight loss and glycemic control benefits long after its
removal, and suggest that these benefits can be extended and improved by
repeating EndoBarrier Therapy for an additional year.

“We had demonstrated in a prior study that EndoBarrier could safely be
re-implanted in patients previously treated for one year,” said Alex Escalona,
M.D., Digestive Surgery, Pontificia Universidad Católica de Chile, Santiago,
Chile. “We are very pleased to see the data from this study which builds on
our feasibility study and indicates that patients who have successfully
completed an initial course of EndoBarrier Therapy can not only maintain a
majority of their weight loss during the interim treatment period, but can
also achieve additional weight loss and metabolic benefits with a second round
of EndoBarrier Therapy.”

These data were presented in a poster titled, “One year follow-up after
re-implantation of the endoscopic duodenal-jejunal bypass liner.” For this
study, 24 obese patients, who were previously implanted with EndoBarrier for
one year and who completed at least 31 weeks of follow-up post EndoBarrier
removal, were invited to participate. Of these, 19 patients were re-implanted
with EndoBarrier and 14 completed a second year of EndoBarrier Therapy. Among
these patients, key treatment results observed from baseline to re-explant of
EndoBarrier included:

  *Total body weight loss of 22.6 kg (p<0.0001);
  *Decrease in body mass index (BMI) from 43.8 ± 5.9 to 33.5 ± 5.2
    (p<0.0001);
  *Total reduction in triglyceride levels of 55.7 (p<0.118);
  *Decrease in FPG from a mean of 106.6 ± 5.2, a diagnosis of prediabetes
    according to the American Diabetes Association (ADA), to a mean of 93.4 ±
    21.3, a reading the ADA considers to be within the normal range (p<0.034);
  *No procedure-related complications associated with re-implantation

Stuart A. Randle, president and chief executive officer of GI Dynamics, Inc.,
stated, “EndoBarrier Therapy has already been proven to be effective in
treating type 2 diabetes and obesity for one year, with sustained benefits
observed for up to 12 months following explant. This re-implantation data
expands our current understanding by demonstrating that the overall health
benefits of initial EndoBarrier Therapy can be safely extended and improved
following a second treatment period.”

EndoBarrier Therapy is currently available in select countries in Europe,
including The Netherlands, Austria, Germany and the United Kingdom, as well as
Australia and Chile. In August, GI Dynamics also received conditional approval
from the U.S. Food and Drug Administration to commence a pivotal clinical
trial of EndoBarrier in the United States for the treatment of patients who
have uncontrolled type 2 diabetes and are obese.

About EndoBarrier

EndoBarrier Therapy is a revolutionary, non-surgical, non-pharmaceutical
treatment for people with type 2 diabetes and/or obesity. Clinical studies
demonstrate that EndoBarrier Therapy achieves rapid and dramatic reductions in
blood sugar levels, improvement of cardiovascular risk factors including blood
pressure, cholesterol and triglycerides,^1,2 and weight loss of approximately
20 percent in 12 months. EndoBarrier Therapy is an effective, convenient and
discreet treatment for people whose diabetes medications are no longer
effective, who are at risk for serious health complications and who want to
avoid the progression to daily insulin injections. Involving a brief
endoscopic procedure, EndoBarrier Therapy also enables patients to avoid the
lifestyle changes and frequent post-surgical interventions associated with
irreversible bypass surgery and gastric banding. This first-of-its-kind
therapy is helping patients around the world fight their battle against type 2
diabetes and obesity while providing a pathway to a healthier lifestyle. For
more information, please visit www.EndoBarrier.com.

About GI Dynamics

GI Dynamics, Inc. (ASX: GID) is pioneering the development and
commercialization of effective, non-surgical treatments targeting the large
and growing global patient populations with type 2 diabetes and obesity. The
company’s flagship product, EndoBarrier®, is a novel, non-surgical device
proven to lower blood glucose levels and promote weight loss in diabetic
patients and/or obese patients during the implant period. GI Dynamics
currently markets EndoBarrier in select regions in Europe, South America and
Australia and is planning near-term commercial expansion into additional
markets. The EndoBarrier is not approved for sale in the United States and is
considered investigational. Founded in 2003, GI Dynamics is headquartered in
Lexington, Massachusetts. For more information, please visit
www.gidynamics.com.

Forward-Looking Statements

This announcement contains or may contain forward-looking statements that are
based on management’s beliefs, assumptions and expectations and on information
currently available to management. All statements that address operating
performance, events or developments that we expect or anticipate will occur in
the future are forward-looking statements, including without limitation our
expectations with respect to our ability to commercialize our EndoBarrier®
including our estimates of potential revenues, costs, profitability and
financial performance; our ability to develop and commercialize new products
including our ability to obtain reimbursement for our products; our
expectations with respect to our clinical trials, including enrolment in or
completion of our clinical trials and our associated regulatory submissions
and approvals; and our expectations with respect to the integrity or
capabilities of our intellectual property position. Management believes that
these forward-looking statements are reasonable as and when made. You should
not place undue reliance on forward-looking statements because they speak only
as of the date when made. GI Dynamics does not assume any obligation to
publicly update or revise any forward-looking statements, whether as a result
of new information, future events or otherwise. GI Dynamics may not actually
achieve the plans, projections or expectations disclosed in forward-looking
statements, and actual results, developments or events could differ materially
from those disclosed in the forward-looking statements. Forward-looking
statements are subject to a number of risks and uncertainties, described in
“Risk Factors” in our Prospectus lodged with the Australian Securities &
Investments Commission on 3 August 2011.

^1 Moura, GHD, et al, One Year Results of an Endoscopic, Duodenal-Jejunal
Exclusion Device for Weight Loss and Control of Type 2 Diabetes. Hospital das
Clinicas, University of São Paulo, São Paulo, Brazil. DT&T, February 2012, vol
14, no.2:183-189.

^2 Escalona, A., et al, “Post-explant follow-up after 12 months implantation
of an endoscopic duodenal-jejunal bypass liner.” Department of Digestive
Surgery. Faculty of Medicine Pontificia Universidad Católica de Chile. Annals
of Surgery, June 2012, Vol 255, Issue 6, p 1080–1085.

Contact:

United States:
GI Dynamics, Inc.
Robert Crane, Chief Financial Officer, +1 781-357-3250
or
Australia:
Inteq Limited
Kim Jacobs, +61 2 9231 3322
or
North America/Europe:
Pure Communications Inc.
Dan Budwick, + 1 973-271-6085
or
Australia:
Buchan Consulting Group
Haley Price, +61 3 8866 1215
 
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