BOSTON and SYDNEY — 8 May 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, has announced additional members of the GI Dynamics Scientific Advisory Board (SAB), bringing together distinguished physicians and scientists specializing in endocrinology, gastroenterology and bariatric/metabolic surgery. Ricardo Cohen, MD, and Christopher Thompson, MD, MHES, have joined the GI Dynamics SAB.
The GI Dynamics SAB was created to further advance the body of evidence regarding EndoBarrier and advance the state of patient care with EndoBarrier. The SAB will serve as a key resource for GI Dynamics during the Investigational Device Exemption clinical trial of EndoBarrier in the United States as well as supporting ongoing clinical studies and the commercialization process in the United Kingdom, Germany, the Middle East, and select European countries.
“Dr. Cohen and Dr. Thompson will be valued members of the GI Dynamics SAB,” said Scott Schorer, GI Dynamics president and CEO. “Dr. Cohen is a leader in the type 2 diabetes and obesity field and has developed a rich history with EndoBarrier, starting with early clinical work. Dr. Thompson is a gifted gastroenterologist with deep experience in complex primary and revision procedures. He is highly experienced in new technology development and generates significant research through his clinical team,” concluded Schorer.
Dr. Cohen is the director for the Center for Obesity and Diabetes at the Oswaldo Cruz German Hospital located in São Paulo, Brazil. Dr. Cohen is also the former president of the Brazilian Society of Bariatric and Metabolic Surgery, and is the current president of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), Latin America Chapter.
Dr. Cohen has been the primary investigator (PI) for 15 studies, including two EndoBarrier studies. He has published more than 150 papers and is considered a leader in the field of surgery for patients with type 2 diabetes and non-severe obesity.
“GI Dynamics with EndoBarrier has produced an excellent adjuvant tool to achieve diabetes control,” said Dr. Cohen. “I look forward to helping GI Dynamics continue to develop EndoBarrier to provide a safe and effective device in a treatment area that is growing rapidly.”
Dr. Thompson is the director of Therapeutic Endoscopy at Brigham Women’s Hospital and an associate professor of Medicine at Harvard Medical School in Massachusetts. He is also the current chair of the Association of Bariatric Endoscopy (ABE). He started his career in medicine after receiving his MD from Pennsylvania State University, College of Medicine in Hershey, Pennsylvania. He went on to receive his MSc in health evaluation science.
Dr. Thompson has more than 200 academic publications to his name, and he has been the PI in numerous clinical trials. He is particularly well-known for his work on metabolic therapies for obesity. He is the editor of the first textbook on bariatric endoscopy, and he has trained numerous fellows in the field.
“EndoBarrier is an exciting and novel technology that fills a rapidly expanding treatment gap in the management of type 2 diabetes and obesity. The GI Dynamics team has pioneered the advancement of our understanding of disease and treatment mechanisms over the past decade, and this device holds tremendous promise,” said Dr. Thompson. “I am thrilled to be joining such an accomplished group of clinicians and look forward to collaborating with them.”
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 Boston, Massachusetts. For more information, please visit www.gidynamics.com.
This announcement contains forward-looking statements concerning our development and commercialization plans, potential revenues and revenue growth, costs, excess inventory, profitability and financial performance, ability to obtain reimbursement for our products, 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 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 the consequences of terminating the ENDO trial and the possibility that future clinical trials will not be successful or confirm earlier results. Further risks are associated with obtaining funding from third parties; the timing and costs of clinical trials; the timing of regulatory submissions; and 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 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.