BOSTON and SYDNEY — 4 April 2019 — 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 EndoBarrier data will be presented at the 4th World Congress on Interventional Therapies for Type 2 Diabetes (WCITD), taking place 8 – 10 April 2019 in New York City. During the forum, Scott Schorer, president and chief executive officer of GI Dynamics will participate in a panel discussion focused on device innovation.

The WCITD was established to provide a multidisciplinary forum focused on bariatric/metabolic surgery and innovative gastrointestinal-based interventions for type 2 diabetes, as well as how the gastrointestinal tract plays a role in metabolic regulation.

The goal for the 4th WCITD is to engage leading experts and stakeholders to aid in the implementation of current guidelines for the surgical treatment of type 2 diabetes. The forum is also seeking a way to provide better treatment options and care for people who have been diagnosed with type 2 diabetes and obesity by eliminating the stigma and ending discrimination against this patient population.

The following EndoBarrier studies will be presented via poster exhibit:

UK First National Health Service (NHS) EndoBarrier Service for Uncontrolled Diabesity Shows the Metabolic Improvements 6-Months after EndoBarrier Removal are Well Maintained
Presenter:       Robert Ryder, M.D., Sandwell and West Birmingham Hospitals
Birmingham, U.K.

Impact of EndoBarrier on Need for Continuous-Positive-Airway-Pressure Ventilation (CPAP) in Diabetes/Pre-Diabetes with Obstructive Sleep Apnoea (OSA) Study: Current Data at EndoBarrier Removal and 6-Months Later
Presenter:       Robert Ryder, M.D., Sandwell and West Birmingham Hospitals
Birmingham, U.K.

Evaluation of the Efficacy and Safety of Endoscopically Achieved Proximal Intestinal Exclusion as an Adjunct to Glucagon-Like Peptide-1 Therapy in Diabesity: REVISE Diabesity Randomised Clinical Trial
Presenter:       Piya Sen Gupta, M.D., King’s College London
London, U.K.

Duodenal-Jejunal Bypass Liner for Diabesity – Risk Versus Benefit Data from the Association of British Clinical Diabetologists (ABCD) Worldwide EndoBarrier Registry
Presenter:       Robert Ryder, M.D., Sandwell and West Birmingham Hospitals
Birmingham, U.K.

Schorer will participate as an industry expert on a panel focused on innovation of novel devices, “How to Ensure Safety and Expedite Innovation for Novel Surgical and Device-Based Procedures.”

GI Dynamics is honored to support this forum as a Silver Supporter. In addition, three of the company’s Scientific Advisory Board (SAB) members are among the organizing committee for the WCITD; Francesco Rubino, M.D., professor of metabolic and bariatric surgery at King’s College London – Congress Director; David Cummings, M.D., professor of medicine in the Division of Metabolism, Endocrinology and Nutrition at the University of Washington – Co-Chair; Philip Schauer, M.D., professor of surgery at the Cleveland Clinic and director of the Cleveland Clinic Bariatric and Metabolic Institute  – Co-Chair. In addition to the organizing committee, the following SAB members will be represented on the faculty: Ricardo Cohen, M.D., Manoel Galvao Neto, M.D., and Carel LeRoux, M.D, Ph.D.

“The WCITD is a multidisciplinary forum expressly designed to discuss the science that supports clinical utilization of minimally invasive procedures and devices that can help combat the worldwide pandemic of type 2 diabetes and obesity,” said Francesco Rubino, M.D., congress director of the WCITD and professor of metabolic and bariatric surgery at King’s College London, London UK. “We are pleased to provide this forum to discuss the clinical and biological evidence behind innovative technologies such as EndoBarrier.”

For more information on the 4th WCITD and its agenda, please visit www.wcitd.com.

 

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 www.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 and to conduct the planned pivotal trial of EndoBarrier in the United States (GID 18-1); our ability to execute the GID 18-1 under FDA’s Investigational Device Exemption; our ability to enlist clinical trial sites and enroll patients in accordance with the GID 18-1; the risk that the FDA stops the GID 18-1 early as a result of the occurrence of certain safety events or does not approve an expansion of the GID 18-1; 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 May 2019; our ability to restructure the terms of the convertible note with Crystal Amber Fund Limited that is due in May 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.

###