Market Overview

GI Dynamics Announces FDA Approval for EndoBarrier Pivotal Trial


Pivotal trial to focus on reduction of hemoglobin A1c for patients
diagnosed with type 2 diabetes and obesity

GI Dynamics Inc. (ASX:GID):

• Primary Endpoint


Reduction of HbA1c at 1 year

• Planned Study Size

Stage I: 50 EndoBarrier / 17 control

Stage II (upon FDA approval): 130 EndoBarrier / 43 control

Total: 240 Participants (3:1): 180 EndoBarrier / 60 control

• Participant Timing

1 year EndoBarrier implant or control / 1 year follow-up

• Safety Review

Interim FDA Safety Review of 50 EndoBarrier participants

GI Dynamics Inc. (ASX:GID), a medical device company that is developing
EndoBarrier for patients diagnosed with type 2 diabetes and obesity, is
pleased to announce it has received approval of an investigational
device exemption (IDE) from the U.S. Food and Drug Administration (FDA)
to begin enrollment in a pivotal trial evaluating the safety and
efficacy of EndoBarrier in the United States pending Institutional
Review Board (IRB) approval.

The primary endpoint of the pivotal trial (GID 18-1) is reduction in
average blood sugar levels (HbA1c) at 1 year. The pivotal trial will
consist of randomized EndoBarrier implant and control arms; both arms
will receive identical lifestyle therapy that complies with the most
current American Heart Association guidelines.

The study is approved for staged enrollment, with the initial approval
for treatment of up to 67 study participants including 50 EndoBarrier
and approximately 17 control participants. Following FDA review of the
interim safety report, the company will apply for approval to expand
enrollment to a planned total study population of approximately 240
participants. The FDA has recommended certain study modifications that
will be submitted by the company in an IDE supplement.

"This pivotal trial offers an opportunity to evaluate the safety and
efficacy of EndoBarrier on a comprehensive basis," said David Cummings,
MD, Endocrinologist at University of Washington and Veterans Affairs
Puget Sound Health Care System-Seattle and GI Dynamics Scientific
Advisory Board (SAB) member. "The GI Dynamics SAB has worked closely
with the company to design a study that measures critical health metrics
and applies best practices to minimize clinical risk."

"This IDE approval is the result of more than two years of scientific
investigation and research focused on clinical trial design in
collaboration with the FDA, with the intent of designing a robust
pivotal trial focused on the treatment of type 2 diabetes," said Scott
Schorer, president and chief executive officer of GI Dynamics.
"EndoBarrier remains one of the few technologies focused on the primary
target of achieving glycemic control for patients diagnosed with type 2
diabetes that is not bariatric/metabolic surgery or anti-diabetes

GI Dynamics leveraged clinical data from nearly 4,000 EndoBarrier
implants since inception, the initial US clinical trial (ENDO Trial),
multiple investigator-initiated clinical trials, two ongoing registries
(ABCD Worldwide EndoBarrier Registry, German EndoBarrier Registry), and
the comprehensive EndoBarrier
recently published
in the American Diabetes Association's (ADA) Diabetes Care journal.

Patient safety is of paramount importance to GI Dynamics. The company
and the FDA have agreed to a multiple stage pivotal trial and the
implementation of safety monitoring procedures during the study. The
approved Stage I will consist of the first 50 EndoBarrier recipients and
approximately 17 control arm participants. When the first 50 EndoBarrier
recipients have reached the 6-month (post implantation) follow-up, a
Stage I safety report will be provided to the FDA for review. Upon
completion of Stage I and with FDA approval, enrollment of the remaining
participants is planned for a total of 240 participants.

In addition, GI Dynamics and the FDA have agreed on several specific
safety events that, if reported, will cause enrollment to be stopped
while the GID 18-1 Data Safety Monitoring Board, GI Dynamics, and the
FDA conduct a review of all study safety data to determine whether the
study may continue.

The specific safety events that would cause the enrollment to stop
during Stage I are presented as follows:

  • One (1) hepatic abscess requiring a procedure other than image-guided
    fine needle aspiration (FNA) and/or oral antibiotic therapy
  • Three (3) hepatic abscesses requiring oral antibiotics with or without
    fine needle aspiration
  • One (1) instance of device-related bleeding requiring transfusion or
    embolization or Intensive Care Unit (ICU) care
  • Three (3) instances of endoscopic intervention that includes
    cauterization or endoscopic clipping of a bleeding lesion

GI Dynamics, in conjunction with its scientific and medical advisors and
leveraging significant investigative work and analysis, has implemented
multiple clinical risk management steps to mitigate the risk of
occurrence of all known safety events. This includes the elimination of
proton pump inhibitors (which are thought to increase liver abscess
risk), refinement of inclusion criteria, addition of multiple exclusion
criteria, the implementation of a higher threshold of failed medical
therapy prior to EndoBarrier treatment, and increased patient monitoring
with the intent of reducing patient risk and addressing clinical issues
identified in the past, such as liver abscess.

"The GID 18-1 trial design is intended to address the patient population
that has failed lifestyle and medical therapy prior to insulin use,"
said Schorer. "This study will gather data on insulin sensitivity, the
avoidance of insulin use, cardiovascular risk factor reduction (as
measured by blood pressure, cholesterol, and triglycerides), and the
reduction of severity of specific types of liver disease: nonalcoholic
fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).
This pivotal trial is a substantial undertaking that is intended to
create significant clinical value. The team of employees, clinicians,
and directors of the company are committed to investigating the safety
and efficacy of EndoBarrier to treat type 2 diabetes and associated

Subject to securing additional financing in 2018, GI Dynamics expects to
complete enrollment of Stage I of the study during the first half of

Further information will be provided during the company's next
shareholder update call, scheduled for 20 August 2018 at 6pm EDT │ 21
August 2018 at 8am AEST. The company will provide full meeting details

About GI Dynamics

GI Dynamics Inc. (ASX:GID) is the developer of EndoBarrier, an
endoscopically delivered device therapy for the treatment of type 2
diabetes and obesity. EndoBarrier is not approved for sale and is
limited by federal law to investigative use only. Founded in 2003, GI
Dynamics is headquartered in Boston, Massachusetts. For more
information, please visit

Forward-Looking Statements

The announcement may contain forward-looking statements. These
statements are based on GI Dynamics management's current estimates and
expectations of future events as of the date of this announcement.
Furthermore, the estimates are subject to several risks and
uncertainties that could cause actual results to differ materially and
adversely from those indicated in or implied by such forward-looking

These risks and uncertainties include, but are not limited to, risks
associated with our ability to continue to operate as a going concern;
our ability to raise sufficient additional funds to continue operations
and to conduct the planned clinical trial of EndoBarrier in the United
States (GID 18-1 Trial); our ability to execute the GID 18-1 Trial under
FDA IDE; our ability to enlist clinical trial sites and enroll patients
in accordance with the GID 18-1 Trial; the risk that the FDA stops the
GID 18-1 Trial early as a result of the occurrence of certain safety
events or does not approve an expansion of the GID 18-1 trial; our
ability to maintain compliance with our obligations under our existing
convertible note and warrant agreements executed with Crystal Amber Fund
Limited, including our obligations to make payment on the relevant notes
that are due in December 2018; obtaining and maintaining regulatory
approvals required to market and sell our products; the possibility that
future clinical trials will not be successful or confirm earlier
results; the timing and costs of clinical trials; the timing of
regulatory submissions; the timing, receipt and maintenance of
regulatory approvals; the timing and amount of other expenses; the
timing and extent of third-party reimbursement; intellectual-property
risk; risks related to excess inventory; risks related to assumptions
regarding the size of the available market; the benefits of our
products; product pricing; timing of product launches; future financial
results; and other factors, including those described in our filings
with the U.S. Securities and Exchange Commission.

Given these uncertainties, one should not place undue reliance on these
forward-looking statements. We do not assume any obligation to publicly
update or revise any forward-looking statements, whether as a result of
new information or future events or otherwise, unless we are required to
do so by law.

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