BOSTON and SYDNEY — 7 March 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, announced the creation of the GI Dynamics Scientific Advisory Board (SAB). The GI Dynamics SAB will endeavor to bring together distinguished physicians and scientists specializing in endocrinology, gastroenterology and metabolic surgery to advance the evidence-based understanding of EndoBarrier and support its optimal usage. Professor Carel Le Roux, MD, PhD and Professor Jan Willem Greve, MD, PhD, are the first two members to join the SAB.
The GI Dynamics SAB was created to help the company advance the body of evidence supporting clinical use of EndoBarrier, ask and answer relevant questions about the treatment paradigm and advance the state of patient care for type 2 diabetes and obesity. The group will serve as a critical resource to GI Dynamics during the investigational device exemption trial of EndoBarrier in the United States, and will support ongoing clinical studies and commercialization in the United Kingdom, Germany, the Middle East and additional European countries.
“We look forward to working with professors Le Roux and Greve to help us improve clinical options for patients with type 2 diabetes and obesity with EndoBarrier,” said Scott Schorer, GI Dynamics president and CEO. “As an endocrinologist, professor Le Roux brings a deep understanding of the disease states we are treating. Professor Greve, who has been a primary investigator on two EndoBarrier trials, brings the perspective of an experienced bariatric / metabolic surgeon.”
Le Roux serves as the head of pathology at the University College Dublin in Ireland. He graduated from medical school in Pretoria, South Africa, where he completed his specialist training in metabolic medicine at St. Bartholomew’s Hospitals and Hammersmith Hospitals. He completed his PhD at Imperial College London and was later promoted to Reader. He received a Clinician Scientist Award from the UK National Institute of Health Research and a Wellcome Trust Clinical Research Fellowship for his work on how the gut communicates with the brain.
“Type 2 diabetes remains one of the most challenging chronic diseases people struggle with. Novel and scalable treatments that can have a positive impact on people’s lives are urgently needed,” said Le Roux. “EndoBarrier has broken the mold of how we used to think about novel treatments for diabetes.”
Greve serves as medical director of the Dutch Obesity Clinics South and chair of the Metabolic and Bariatric Surgery Unit at the Zuyderland Medical Center in the Netherlands. Greve received his PhD at the Academic Hospital in Maastricht, Netherlands, has served on numerous committees, supervised 15 doctoral theses and authored more than 185 peer-reviewed papers and numerous book chapters on intensive care medicine, nutrition and bariatric and metabolic surgery. He was principal investigator of two European EndoBarrier clinical trials and other single-center and multicenter studies.
“Obesity and its co-morbidities are an immense challenge for modern health care,” said Greve. “Bariatric or metabolic surgery is a proven tool to treat morbidly obese patients with type 2 diabetes. However, the majority of these patients may have a BMI that is too low or have serious contraindications that preclude them from being candidates for such an invasive surgical procedure. As a bariatric / metabolic surgeon, I believe EndoBarrier is a powerful addition to our treatment armamentarium.”
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 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 stopping 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.