GI Dynamics Announces Agreement with Apollo Sugar to Study EndoBarrier in India

BOSTON SYDNEY HYDERABAD, India–(BUSINESS WIRE)–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 that it has entered today into an agreement with
Apollo Sugar1 to jointly study the safety and efficacy of
EndoBarrier in India.

Apollo Sugar is a collaboration between Apollo Health Lifestyle
Limited and Sanofi2. Apollo Sugar is a division of Apollo
Hospitals Group (Apollo) focused on the treatment of metabolic disorders
and operates an integrated network of centers of excellence for
diabetes, obesity and endocrinology. Apollo is the largest hospital
system in India and has emerged as Asia’s foremost integrated healthcare
services provider, maintaining a robust presence of hospitals,
pharmacies, primary care and diagnostic clinics across the healthcare
ecosystem. Since its inception, Apollo has treated over 65 million
patients from 141 countries.

The agreement between Apollo Sugar and GI Dynamics provides for the
commencement of a clinical trial, pending appropriate regulatory
submissions and approvals, that consists of 100 patients randomized into
75 EndoBarrier and 25 control patients with a 3-to-1 ratio. Subject to
GI Dynamics raising additional capital, enrollment is expected to
commence in the first half of 2019 and conclude by the end of the third
quarter of 2019.

GI Dynamics and Apollo Sugar have agreed to work toward setting the
terms of a joint partnership that will focus on the marketing,
distribution and clinical support of EndoBarrier to appropriate patients
throughout India and Southeast Asia. Final terms of the proposed
collaboration are subject to negotiation and will be disclosed upon
completion.

Commenting on the collaboration, Gagan Bhalla, chief executive officer
of Apollo Sugar, said, “Apollo Sugar is pleased to work with GI Dynamics
to study EndoBarrier as an innovative means of treating patients
diagnosed with type 2 diabetes and obesity. Apollo Hospitals have always
focused on providing advanced, safe and effective treatments to its
patients. We believe EndoBarrier can provide a novel and powerful
clinical tool for our clinicians, and we look forward to studying
EndoBarrier in our hospitals for patients based in India and Southeast
Asia.”

Commenting on the collaboration, Scott Schorer, president and chief
executive officer of GI Dynamics, said, “We are pleased to announce this
clinical trial as a first part of a partnership with Apollo Sugar to
study EndoBarrier in India. We look forward to working closely with the
clinical team at Apollo Sugar to first study the safety and efficacy of
EndoBarrier in the region and then supply EndoBarrier to appropriate
patients within the region.”

About Apollo Sugar

Apollo Sugar is an innovative, single-specialty diabetes and endocrine
healthcare service provider formed as a collaboration between Apollo
Health Lifestyle and Sanofi. Recognizing the epidemic scale and
complications of this disease in the region, the Apollo Hospitals Group
created the Apollo Sugar model. This initiative aims to reach out to the
larger population and address the ever-increasing health concerns of
type 1 and type 2 diabetes, gestational diabetes and prediabetes
populations with specialized and comprehensive multidisciplinary
integrated care models that are personalized, intensive and proven to
deliver results.

This proven model of success aims to provide patients with accessible
care for diabetes and continues to expand its network across India.
Apollo Sugar’s mission is to touch the lives of a million diabetic
patients and make diabetes “disease free” by delivering the best
outcomes via a proven, patient-centric care model that combines
comprehensive clinical care with sustained lifestyle management
and behavioral modification in the individual.

For more information, please visit apollosugar.com.

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 gidynamics.com.

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
statements.

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,
to conduct the planned pivotal trial of EndoBarrier in the United States
(GID 18-1), and to conduct the planned clinical trial of EndoBarrier in
India; our ability to execute GID 18-1 under FDA IDE; our ability to
enlist clinical trial sites and enroll patients in accordance with GID
18-1; the risk that the FDA stops GID 18-1 early as a result of the
occurrence of certain safety events or does not approve an expansion of
GID 18-1; our ability to conduct the clinical trial with Apollo Sugar in
India; the risk that potential clinical issues that may occur in the
Apollo Sugar trial in India affect GID 18-1 and future FDA
communications; our ability to negotiate a definitive agreement for the
marketing, distribution and clinical support of EndoBarrier following
the completion of the proposed clinical trial in India; 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.

1 Apollo Sugar Clinics (apollosugar.com),
a division of Apollo Hospitals Group (apollohospitals.com)
2
Sanofi (sanofi.com)

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