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.
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
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
GI Dynamics, Inc.
Shields, +1 781-357-3280