BOSTON and SYDNEY — 14 August 2017 — GI Dynamics® Inc. (ASX:GID), a medical device company that has commercialized EndoBarrier® in Europe, the Middle East and South America for patients with type 2 diabetes and obesity, welcomed new members to the GI Dynamics Scientific Advisory Board (SAB), bringing together distinguished physicians and scientists specializing in endocrinology, gastroenterology and bariatric/metabolic surgery. Gerald Holtmann, MD, and Thomas Rösch, MD, have joined the GI Dynamics SAB.
The GI Dynamics SAB was designed to advance the body of evidence and state of patient care through EndoBarrier utilization. The SAB will serve as a key resource to GI Dynamics during its Investigational Device Exemption clinical trial in the United States and will support ongoing clinical studies and commercialization in the United Kingdom, Germany, the Middle East and select European countries.
“We are honored to have Dr. Holtmann and Dr. Rösch join the GI Dynamics SAB,” said Scott Schorer, president and chief executive officer of GI Dynamics. “Dr. Holtmann has developed a rich experience with EndoBarrier, and is currently the primary investigator of the ’Effects and Mechanisms of Action of an Endoscopically Placed Duodenal-Jejunal Sleeve Device (EndoBarrier) in Obese Patients with Type 2 Diabetes: Focus on Intraluminal Triglyceride Digestion’ in Brisbane, Australia. Dr. Rösch has extensive gastroenterology and endoscopy experience; he conducted the first EndoBarrier procedures in Germany, and is leading the refinement of understanding mechanisms of action and the improvement of gastroenterological treatment protocols.”
Dr. Holtmann is associate dean clinical at The University of Queensland and director of gastroenterology and hepatology at the Princess Alexandra Hospital in Brisbane. He also serves as director on boards of the West Moreton Hospital and Health Service and the Gallipoli Foundation.
In addition to Dr. Holtmann’s training in medicine and gastroenterology, he completed a Master of Business Administration degree at the University of South Australia and is certified by the German Board of Physicians in Medical Informatics and Biostatistics. He has published more than 300 articles and book chapters in leading journals including the New England Journal of Medicine, Lancet, Gut and Gastroenterology, and has garnered more than 16,000 citations.
In May 2016, Dr. Holtmann presented a poster on ‘Endoscopic Treatment of Obesity with a Duodenal-Jejunal Bypass Sleeve: Does Impairment of Fat Absorption Explain Weight Loss?’ at Digestive Disease Week (DDW). He also presented a poster on ‘Improvements of Liver and Glycemic Parameters After Duodenal-Jejunal Bypass Sleeve (DJBS) Insertion’ at DDW.
“With my current research focused on the role of gut microbiome and brain–gut interactions, I’m excited to contribute to the GI Dynamics SAB,” said Dr. Holtmann. “Understanding the role of EndoBarrier should produce interesting research that will hopefully help patients.”
Dr. Rösch is director of the Department of Interdisciplinary Endoscopy at the University Hospital Eppendorf in Hamburg, Germany. He previously was the chief of endoscopy and professor of diagnostic and therapeutic endoscopy at Charité Berlin, Campus Virchow Hospital from 2004 to 2008.
Dr. Rösch has performed experimental studies on the topic of the secretion of pancreatic enzymes and has conducted scientific activity with endoscopy and endosonography in gastrointestinal diagnostics. His gastrointestinal research has been featured in over 230 publications, numerous review articles and more than 1,500 lectures. Dr. Rösch is also the editor of two endoscopic ultrasonography books and was editor in chief of the Endoscopy journal from 2004 to 2013, as well as deputy editor of endoscopy for the Gut journal. He is a board member of the German Society of Gastroenterology (DGVS) and of the DGVS Endoscopic Section.
Dr. Rösch’s most recent study, ‘Performance Measures for Lower Gastrointestinal Endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative,’ is a multi-center approach by the ESGE and United European Gastroenterology. The study presented a list of key performance measures for lower gastrointestinal endoscopy to be adopted by pan-European endoscopy services.
“The innovation of endoscopic procedures continues to advance treatments in many disease states,” said Dr. Rösch. “By being part of the GI Dynamics Scientific Advisory Board, I will have the opportunity to help understand these innovations and hopefully advance treatment for the many people diagnosed with obesity and type 2 diabetes.”
About GI Dynamics
GI Dynamics, Inc. (ASX:GID) is the developer of EndoBarrier, the first endoscopically-delivered device approved for the treatment of type 2 diabetes and obesity. 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 Boston, Massachusetts. For more information, please visit www.gidynamics.com.
This announcement contains forward-looking statements concerning the potential for EndoBarrier as an important treatment option for patients with type 2 diabetes and obesity. These forward-looking 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 obtaining funding from third parties; the consequences of stopping the ENDO trial and 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; risks associated with commercial product sales, including product performance, competition, market acceptance of products, intellectual-property risk; risks related to excess inventory; and 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.