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
Saturday, June 11 | 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) Katharina Laubner, Universitätsklinikum Freiburg, Germany | ||
326-LB Sunday, June 12 12 to 2 p.m. |
EndoBarrier Therapy is Associated with Glycemic Improvement, 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 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.
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