BOSTON and SYDNEY — 6 June 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 American Diabetes Association’s 79th Scientific Sessions, taking place 7 – 11 June 2019 in San Francisco, California.

The American Diabetes Association (ADA) Scientific Sessions provide an environment in which researchers and health care professionals exchange ideas and learn from new discoveries in diabetes research, care, and treatment. Throughout the 5-day conference, researchers and experts will present and exchange their latest findings in treating diabetes.

 

The following EndoBarrier studies will be presented:

UK First National Health Service (NHS) EndoBarrier (EB) Service: Maintenance of Improvement One Year after Device Removal

Presenter:       Robert Ryder, M.D., Sandwell and West Birmingham Hospitals, Birmingham, U.K.

Session:          Abstract Presentation

Location:         Poster Hall (Hall F, North, Exhibition Level)

Date:               8 and 10 June 2019 at 12:30 PM

 

Effect of Endoscopic Duodenal-Jejunal Bypass Liner on Parameters of Insulin Sensitivity and Secretion in Subjects with Type 2 Diabetes Mellitus and Obesity

Presenter:       Michaela Kudlackova M.D., Ph.D., Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic

Session:          Abstract Presentation

Location:         Poster Hall (Hall F, North, Exhibition Level)

Date:               9 June 2019 at 12:00 PM

 

EndoBarrier (EB) in Diabetes/Prediabetes with Obstructive Sleep Apnea (OSA) Study—Maintenance of Improvement after EB Removal

Presenter:       Mahender Yadagiri, M.D., Sandwell and West Birmingham Hospitals, Birmingham, U.K.

Session:          Abstract Presentation

Location:         Poster Hall (Hall F, North, Exhibition Level)

Date:               10 June 2019 at 12:00 PM

 

Effect of Duodenal-Jejunal Bypass Liner on Cardiovascular Risk in Patients with Type 2 Diabetes and Metabolic Syndrome

Presenter:       Katharina Laubner, M.D., University of Freiburg, Germany

Session:          Oral Presentation

Location:          S-10 (South, Exhibition Level)

Date:                7 June 2019 at 4:15 PM

 

“EndoBarrier is among the leading treatment options for type 2 diabetes,” said Scott Schorer, president and chief executive officer of GI Dynamics. “Continual clinical research on EndoBarrier is necessary for the advancement in treating type 2 diabetes and obesity.”

For more information on the American Diabetes Association’s 79th Scientific Sessions and its agenda, please click here.

 

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

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