GI Dynamics Announces Institutional Review Board Approval for EndoBarrier Pivotal Trial

BOSTON & SYDNEY–(BUSINESS WIRE)–GI Dynamics® Inc. (ASX:GID), a medical device company that is
developing EndoBarrier® for patients with type 2 diabetes and
obesity, is pleased to announce that it has received Institutional
Review Board (IRB) approval to conduct its pivotal trial of EndoBarrier
for type 2 diabetes and obesity.

As announced
on 13 August 2018, the pivotal trial of EndoBarrier, referred to as the

18-1 study, is a randomized (3:1) controlled double-blinded clinical
trial designed to measure the efficacy and safety of EndoBarrier in
conjunction with lifestyle therapy and diabetes medication for the
treatment of type 2 diabetes and obesity vs. a sham control arm in
conjunction with lifestyle therapy and diabetes medication, also for the
treatment of type 2 diabetes and obesity. The 18-1 study will occur in
two stages. Stage I consists of 50 EndoBarrier patients and
approximately 17 control patients and will be completed with the filing
of four Data Monitoring Committee (DMC) reports with the US Food and
Drug Administration (FDA). Upon review of the four DMC reports by the
FDA, the company will apply for approval to conduct Stage II of the
trial, which is projected to include the balance of patients to complete
the 18-1 study total of 240 patients (180 EndoBarrier and 60 control).

IRB approval is required by the FDA and is an essential step to allow
the EndoBarrier pivotal trial to proceed. Western
(WIRB) is serving as the company’s central IRB. GI Dynamics was
notified today that the following EndoBarrier pivotal trial
documentation is approved by WIRB: protocol, informed consent form, and
investigator’s brochure.

“When we announced that the FDA approved our Investigational Device
Exemption (IDE) for the pivotal trial of EndoBarrier, the approval was
conditional upon IRB approval,” said Scott Schorer, president and chief
executive officer of GI Dynamics. “This IRB approval now satisfies that
condition. In parallel, we continue to push forward with the clinical
study sites that will be part of the 18-1 study and we anticipate being
in a position to announce these clinical sites shortly.”

About GI Dynamics

GI Dynamics®, Inc. (ASX:GID) is the developer of EndoBarrier®,
the first 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 investigational use only. Founded in 2003, GI
Dynamics is headquartered in Boston, Massachusetts. For more information
please visit

Forward-Looking Statements

This 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 pivotal trial of EndoBarrier in the United
States (18-1 study); our ability to execute the 18-1 study under FDA’s
Investigational Device Exemption; our ability to enlist clinical trial
sites and enroll patients in accordance with the 18-1 study; the risk
that the FDA stops the 18-1 study early as a result of the occurrence of
certain safety events or does not approve an expansion of the 18-1
study; 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 note that is due in March 2019; our ability to restructure the
terms of the convertible note with Crystal Amber Fund Limited that is
due in March 2019 if we are unable to raise sufficient funds to enable
us to fully repay such note when due; 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.


United States:
Janell Shields
+1 (781) 357-3280

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