LEXINGTON, Mass. and SYDNEY – 17 September 2013 – GI Dynamics, Inc. (ASX: GID) today announced recent clinical research presentations and peer-reviewed publications about EndoBarrier® Therapy and an update from the successful, inaugural meeting of its European Union Advisory Board.
“The progressive nature of type 2 diabetes and obesity poses a significant challenge in clinical practice,” said David Maggs, M.D., chief medical officer, GI Dynamics, Inc. “EndoBarrier Therapy provides the first endoscopically-delivered device treatment for obese patients with type 2 diabetes. The growing interest in this unique therapeutic approach is clearly represented by these most recent clinical disclosures in reputable journals and international congresses, involving endocrinologists, surgeons and allied health care professionals worldwide.”
Recent clinical achievements include:
- Multiple presentations at the 18th World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) held in Istanbul, Turkey, including:
- “EndoBarrier Registry Results – Australia” (H. Frydenberg, M.D., Australia)
- “Gut hormone responses after implantation of a duodenal-jejunal bypass liner and the role in remission of type 2 diabetes in obese patients” (B. Betzel, M.D., the Netherlands)
- “Improvement of type 2 diabetes after implantation of a duodenal-jejunal bypass liner” (B. Betzel, M.D., the Netherlands)
- “Dynamics of lipid profile changes after duodenal-jejunal bypass liner placement” (R. Muñoz, Chile)
- “Is re-implantation of the duodenal-jejunal bypass liner feasible?” (B. Betzel, M.D., the Netherlands)
- “Feasibility of endoscopic implantation of duodenal-jejunal bypass liner under conscious sedation” (B. Betzel, M.D., the Netherlands)
- Publications in peer-reviewed journals:
- Endoscopic duodenal−jejunal bypass liner rapidly improves plasma parameters of nonalcoholic fatty liver disease. de Jonge C. Clinical Gastroenterology and Hepatology. August 2013.
- The feasibility of delivering a duodenal-jejunal bypass liner (endobarrier) endoscopically with patients under conscious sedation. Koehestanie, P. Surgical Endoscopy. August 2013.
- Multiple abstracts accepted for presentation at the 49th Annual Meeting of the European Association for the Study of Diabetes (EASD), which will be held 23-27 September 2013, in Barcelona, Spain.
In addition, GI Dynamics convened the first meeting of its newly formed European Union Advisory Board (EUAB) to discuss current issues in type 2 diabetes care and treatment considerations. Specialists in endocrinology, diabetology and surgery from five countries comprise this multi-disciplinary Advisory Board.
“We were very pleased with the support and feedback we received from our European advisors during the EUAB meeting last month,” stated Dr. Maggs. “We look forward to expanding this group and continuing to engage with them, benefitting from their medical and scientific expertise and their respective insights into local health care delivery needs.”
About GI Dynamics
GI Dynamics, Inc. (ASX: GID) is the developer and marketer of EndoBarrier®, a breakthrough device that represents an entirely new class of non-surgical, non-pharmaceutical therapy for the treatment of type 2 diabetes and/or obesity. EndoBarrier is approved and commercially available in multiple countries outside the U.S. EndoBarrier is not approved for sale in the U.S. and is limited by federal law to investigational use only in the United States. GI Dynamics is conducting a pivotal clinical trial of EndoBarrier in the U.S. for the treatment of patients who have uncontrolled type 2 diabetes and are obese. Founded in 2003, GI Dynamics is headquartered in Lexington, Massachusetts. For more information, please visit www.gidynamics.com.
This announcement contains or may contain forward-looking statements that are based on management’s beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to our ability to commercialize our EndoBarrier® including our estimates of potential revenues, costs, profitability and financial performance; our ability to develop and commercialize new products including our ability to obtain reimbursement for our products; our expectations with respect to our clinical trials, including enrollment in or completion of our clinical trials and our associated regulatory submissions and approvals; our expectations with respect to the integrity or capabilities of our intellectual property position. Management believes that these forward-looking statements are reasonable as and when made. You should not place undue reliance on forward-looking statements because they speak only as of the date when made. GI Dynamics does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. GI Dynamics may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, described in “Risk Factors” in our Prospectus lodged with the Australian Securities & Investments Commission on 3 August 2011.