BOSTON and SYDNEY — 23 July 2019 — GI Dynamics® Inc. (ASX:GID), a medical device company that is developing EndoBarrier® for patients with type 2 diabetes and obesity, is pleased to announce execution of its contract with Thomas Jefferson University in Philadelphia, Pennsylvania as the fourth clinical site of the U.S. pivotal trial of EndoBarrier.
The U.S. pivotal trial of EndoBarrier, STEP-1 (Single Therapy Euglycemic Procedure), formally known as GID 18-1, will begin enrolling patients with type 2 diabetes and obesity during the second half of 2019. The primary endpoint of STEP-1 is reduction in average blood sugar levels (HbA1c) at 12 months of treatment. The pivotal trial will consist of randomized EndoBarrier implant and control arms; both arms will receive identical lifestyle therapy that complies with the most current American Diabetes Association guidelines.
Thomas Jefferson University Hospital (Thomas Jefferson) is a medical institution frequently recognized for its dedication to patient care and the quality of its healthcare professionals, coupled with its drive for innovation and clinical research. Ranked in the top 10 facilities in Pennsylvania by the U.S. News & World Report and the top 100 facilities in America by Becker’s Hospital Review, Thomas Jefferson was commended for the quality of its clinicians by Philadelphia Magazine’s 2019 Top Doctors.
Thomas Jefferson’s Principal Investigator, Austin Lee Chiang, M.D., M.P.H., is an assistant professor and director of the endoscopic bariatric program at Thomas Jefferson. Dr. Chiang’s expertise as a board-certified specialist in gastroenterology, internal medicine, and obesity medicine will provide valuable leadership to the study.
“I am excited for Thomas Jefferson University Hospital to participate in this very important trial in helping identify solutions for patients with type 2 diabetes and other metabolic diseases,” said Dr. Chiang.
“We are pleased to have secured Thomas Jefferson as our fourth clinical site for the STEP-1 trial,” said Steve Linhares, vice president of clinical and regulatory affairs of GI Dynamics. “The team at Thomas Jefferson, lead by Dr. Chiang, will prove to be a solid clinical site with patient safety as their top priority.”
About GI Dynamics
GI Dynamics®, Inc. (ASX:GID) is the developer of EndoBarrier®, the first endoscopically-delivered device therapy for the treatment of type 2 diabetes and obesity. EndoBarrier is not approved for sale and is limited by federal law to investigational use only. Founded in 2003, GI Dynamics is headquartered in Boston, Massachusetts. For more information please visit www.gidynamics.com.
This announcement may contain forward-looking statements. These 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 our ability to continue to operate as a going concern; our ability to raise sufficient additional funds to continue operations and to conduct the planned pivotal trial of EndoBarrier in the United States (STEP-1); our ability to execute STEP-1 under FDA’s Investigational Device Exemption; our ability to enlist clinical trial sites and enroll patients in accordance with STEP-1; the risk that the FDA stops STEP-1 early as a result of the occurrence of certain safety events or does not approve an expansion of STEP-1; our ability to maintain compliance with our obligations under our existing convertible note and warrant agreements executed with Crystal Amber Fund Limited, including our obligations to make payment on the relevant note that is due on 1 October 2019; our ability to restructure the terms of the convertible note with Crystal Amber Fund Limited that is due on 1 October 2019 if we are unable to raise sufficient funds to enable us to fully repay such note when due; obtaining and maintaining regulatory approvals required to market and sell our products; 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; intellectual-property risk; risks related to excess inventory; 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.