BOSTON & SYDNEY--(BUSINESS WIRE)--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 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. Francesco Rubino, MD, and Philip Schauer, 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 delighted to have Dr. Rubino and Dr. Schauer join the GI Dynamics SAB and we look forward to collaborating with them,” said Scott Schorer, GI Dynamics president and chief executive officer. “Dr. Rubino is a pioneer in the field and has helped lead the evolution of bariatric surgery towards metabolic surgery, created the thought process regarding GI tract involvement in the pathophysiology of type 2 diabetes, and independently developed the animal model proof of the EndoBarrier mechanism of action. Dr. Schauer brings a focus on severe obesity and the pathophysiology of type 2 diabetes, is a leading researcher in the disease state, and has performed over 7,000 procedures for type 2 diabetes and obesity.”
Dr. Rubino is internationally recognized as one of the world leaders in the research, education, and practice of metabolic and weight-loss surgery. He received his MD and completed his residency in general surgery at the Catholic University in Rome, Italy. Dr. Rubino completed fellowships in laparoscopic surgery at the European Institute of Telesurgery in Strasbourg, France, at Mount Sinai Medical Center, New York, and at the Cleveland Clinic.
A member of many professional organizations, Dr. Rubino is the recipient of numerous awards, has given hundreds of presentations throughout the world, and is the author of over 100 articles in peer-reviewed journals as well as numerous book chapters. His experimental studies provided the first evidence of a direct effect of gastrointestinal surgery on glucose metabolism independent of weight loss, uncovering a biological link between the gut and diabetes. Dr. Rubino was the main organizer and co-director with Dr. Lee Kaplan and GI Dynamics SAB members Dr. Cummings and Dr. Schauer of the Diabetes Surgery Summit (DSS), an influential consensus conference. The recently released DSS guidelines have been adopted by the American Diabetes Association, and have been endorsed by over 50 scientific societies around the world. Dr. Rubino also served as Congress Director and organizer of the first three editions of the World Congress on Interventional Therapies for Type 2 Diabetes, an international forum for discussion of both conventional surgical interventions and novel endoluminal approaches.
“The potential impact of EndoBarrier for the treatment of both type 2 diabetes and obesity in less obese patients is truly exciting,” says Dr. Rubino. “I look forward to working with the GI Dynamics SAB to further study EndoBarrier and its many benefits for patients.”
Dr. Schauer is the past president of the American Society for Metabolic and Bariatric Surgery and immediate past chair of Obesity Week. He has also served as a co-director of the DSS with Drs. Cummings, Kaplan and Rubino. His clinical areas of expertise include laparoscopic and gastrointestinal surgery. Dr. Schauer received his medical degree from the Baylor College of Medicine, completed his residency in surgery at The University of Texas at San Antonio, and completed his fellowship in laparoscopic surgery at Duke University Medical Center.
Dr. Schauer is board certified in surgery by the American Board of Surgery. He has been the principal investigator or co-investigator on numerous research grants and has published numerous papers, abstracts, and book chapters related to gastrointestinal and laparoscopic surgery. His memberships in professional and scientific societies include the American College of Surgeons, Association of Academic Surgery, Society of University Surgeons, Society of Laparoendoscopic Surgeons, American Society of Bariatric Surgery, Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), and Society for Surgery of the Alimentary Tract.
“EndoBarrier is bridging the gap in care for patients struggling to control their HbA1c levels with ever-increasing doses of insulin but do not meet the criteria for gastric bypass surgery”, says Dr. Schauer. “I am excited to help advance the tools that will provide a powerful treatment option for this patient population.”
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.
Forward-Looking Statements
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.
