GI Dynamics, Inc. (ASX:GID), a medical device company that has developed an innovative endoscopically delivered treatment for type 2 diabetes and obesity, announced today that results from three clinical studies involving EndoBarrier Therapy will be presented at the American Diabetes Association’s (ADA) 76th Scientific Sessions in New Orleans, Louisiana, June 10–14, 2016.

Final data from the ENDO Trial, GI Dynamics’s U.S. pivotal clinical trial of EndoBarrier Therapy, will be presented during a poster session on Sunday, June 12. Previously, preliminary results and the topline results of the ENDO Trial data have been made public. The poster, presented by the ENDO Trial’s coprincipal investigator, Lee Kaplan, M.D., Ph.D., will include primary efficacy and safety data as well as secondary efficacy outcomes.

The dates, times and session numbers for all presentations pertaining to EndoBarrier Therapy are as follows:

 

American Diabetes Association 76th Scientific Sessions

June 10–14 • Ernest N. Morial Convention Center in New Orleans, Louisiana

Moderated
discussion:

Saturday, June 11
12:30 to 1:30 p.m.

   

Benefits Galore of Bariatric Surgery and Bypass Liners—Human Trials

Katharina Laubner, Universitätsklinikum Freiburg, Germany

1978-P

Sunday, June 12

12 to 2 p.m.

   

Bypass Liner Reduces Nonalcoholic Fatty Liver Disease (NAFLD)
in Obese Patients with Type 2 Diabetes (T2DM)

Katharina Laubner, Universitätsklinikum Freiburg, Germany

326-LB

Sunday, June 12

12 to 2 p.m.

   

EndoBarrier Therapy is Associated with Glycemic Improvement,
Weight Loss and Safety Issues in Patients with Obesity and Type 2
Diabetes on Oral Antihyperglycemic Agents

Lee Kaplan et. al., Massachusetts General Hospital, Boston, Massachusetts

263-OR

Sunday, June 12

2:45 to 3 p.m.

   

The Effect of 1-Year’s Endoscopic Proximal Intestinal Exclusion Using
EndoBarrier on 10-Year Cardiovascular Risk in Type 2 Diabetes

Robert E. Ryder et al., Sandwell and West Birmingham Hospitals NHS Trust, UK

   

“We are very excited to release the final results of our ENDO Trial at the American Diabetes Association meeting and to have the opportunity to discuss our data with diabetes experts from around the world,” said Scott Schorer, president and CEO of GI Dynamics, Inc.

“We’re also pleased to have additional aspects of EndoBarrier Therapy – namely, its effect on non-alcoholic fatty liver disease and 10-year cardiovascular risk – presented at ADA, and we’re proud to be included in a moderated discussion on the benefits of bariatric surgery and bypass liners in treating obese type 2 diabetes. We look forward to the presentations of Drs. Laubner, Kaplan and Ryder and appreciate their and their colleagues’ contributions to the body of work supporting EndoBarrier Therapy.”

The company will release further details regarding these presentations following the ADA meeting.

About GI Dynamics
GI Dynamics, Inc. (ASX: GID) is the developer of EndoBarrier®, the first endoscopically delivered device therapy approved for the treatment of type 2 diabetes and obesity. EndoBarrier is approved and commercially available in multiple countries outside the United States. EndoBarrier is not approved for sale in the United States and is limited by federal law to investigational use only in the United States. Founded in 2003, GI Dynamics is headquartered in Lexington, Massachusetts. For more information, please visit www.gidynamics.com.

Forward-Looking Statements
This announcement contains forward-looking statements concerning: our development and commercialization plans; our potential revenues and revenue growth, costs, excess inventory, profitability and financial performance; our ability to obtain reimbursement for our products; our clinical trials, and associated regulatory submissions and approvals; the number and location of commercial centers offering the EndoBarrier; and our intellectual property position. These forward-looking statements are based on the current estimates and expectations of future events by the management of GI Dynamics, Inc. as of the date of this announcement and are subject to a number of 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 the consequences of terminating the ENDO Trial and the possibility that future clinical trials will not be successful or confirm earlier results; risks associated with obtaining funding from third parties; risks relating to 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, and the timing and extent of third-party reimbursement; risks associated with commercial product sales, including product performance; competition; risks related to market acceptance of products; intellectual property risks; risks related to excess inventory; risks related to assumptions regarding the size of the available market, 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, you 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, future events or otherwise, unless required by law.