BOSTON & SYDNEY--(BUSINESS WIRE)--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 the selection of Intertek as the company’s notified body to continue working toward attaining the EndoBarrier CE Mark.
GI Dynamics selected Intertek for its medical device expertise and availability to support the clinical and regulatory requirements of EndoBarrier and GI Dynamics. Intertek, a leading total quality assurance provider, has over 1,000 laboratories and offices and over 42,000 employees in over 100 countries worldwide. Intertek delivers innovative and bespoke assurance, testing, inspection and certification solutions.
As GI Dynamics notified body1, Intertek will confirm that EndoBarrier conforms to the requirements of the European Medical Device Directive MDD93/42/EEC. The confirmation process includes an evaluation of the EndoBarrier technical file including relevant clinical data. Furthermore, Intertek will ensure that the GI Dynamics quality management system is compliant with ISO 13485:2016 requirements.
“Initiating work with Intertek represents a significant step towards achieving an EndoBarrier CE Mark and brings us closer to commercialization in Europe and the Middle East,” said Scott Schorer, president and chief executive officer of GI Dynamics. “This is an important step as we continue to develop EndoBarrier as the lead implant for the treatment of type 2 diabetes and obesity.”
GI Dynamics plans to attain the EndoBarrier CE Mark during the second half of 2019 with the support of Intertek.
About GI Dynamics
GI Dynamics Inc. (ASX: GID) is the developer of EndoBarrier, an 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 investigative use only. Founded in 2003, GI Dynamics is headquartered in Boston, Massachusetts. For more information, please visit gidynamics.com.
Forward-Looking Statements
The 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 clinical trial of EndoBarrier in the United States (GID 18-1 Trial); our ability to execute the GID 18-1 Trial under FDA IDE; our ability to enlist clinical trial sites and enroll patients in accordance with the GID 18-1 Trial; the risk that the FDA stops the GID 18-1 Trial early as a result of the occurrence of certain safety events or does not approve an expansion of the GID 18-1 Trial; 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 notes that are due in December 2018; 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 including the timing and attainment of the EndoBarrier CE Mark; 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.
1 A notified body is an organization designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required. European Commission
