GI Dynamics Receives CE Certificate of Conformity Withdrawal Notice for EndoBarrier
November 12 2017 - 5:09PM
Business Wire
GI Dynamics®, Inc. (ASX:GID), a medical device company that has
commercialized EndoBarrier® in Europe, the Middle East and South
America has received notification from its notified body SGS United
Kingdom, Limited (SGS) that SGS will withdraw the CE Certificate of
Conformity for EndoBarrier effective 12 November 2017.
As previously announced, on 17 May 2017 the company received
notification from SGS that the EndoBarrier CE Certificate of
Conformity was being suspended pending resolution of
nonconformances related to ISO 13485 compliance. The company has
been working diligently to address the issues raised by SGS. On
Saturday 11 November 2017 (AEDT) the company received notification
that SGS will withdraw the CE Certificate of Conformity issued to
the company for EndoBarrier effective 12 November 2017.
The company is evaluating its options including grounds for
appeal of the decision, consulting with its advisors and has
initiated communications with SGS to clarify certain procedural and
substantive matters relating to the notice.
Withdrawal of the CE Certificate of Conformity means that the
company will not be able to affix the CE Mark and sell EndoBarrier
in European Union countries until another Certificate of Conformity
is issued by SGS or another notified body or any appeal is
successful.
The company will provide further updates as information becomes
available.
About GI Dynamics
GI Dynamics, Inc. (ASX:GID), is the developer of EndoBarrier,
the first endoscopically-delivered device therapy 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. 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
and maintaining regulatory approvals required to market and sell
our products; 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.
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Investor RelationsUnited States:GI Dynamics, Inc.Janell
Shields, +1 (781) 357-3280investor@gidynamics.comorMedia
RelationsUnited Kingdom:Walbrook PR Ltd+44 (0)20 7933
8780GID@walbrookpr.com
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