GI Dynamics Announces EndoBarrier CE Mark Suspension
May 17 2017 - 06:07PM
Business Wire
GI Dynamics®, Inc. (ASX:GID) today announced that it received
notification from its notified body SGS United Kingdom Limited
(SGS) that the CE Mark for its EndoBarrier® system has been
suspended pending closure of nonconformances related to its quality
management system required under ISO 13485:2003 and 93/42/EEC.
“This action does not call the safety and efficacy of
EndoBarrier into question and this action does not constitute a
recall,” said Scott Schorer, CEO and president. “We are working
swiftly to address issues within our quality management system that
were detailed in a corrective action report from SGS; we will have
these nonconformances resolved and have our CE Mark reinstated as
quickly as possible.”
Since the new management team at GI Dynamics assumed leadership
last spring, the company has been working diligently to address
these and other issues. The company has shipped what it believes
will be sufficient inventory to its customers to ensure
uninterrupted service during the suspension. In addition, all
implanted patients may continue treatment subject to normal ongoing
evaluation and monitoring by their healthcare professional.
Specific plans and actions have been initiated to address the
nonconformances identified by SGS.
“We hired a chief compliance officer with experience in these
matters as well as quality and regulatory experts to help us
address the issues while maintaining compliant surveillance and
vigilance,” Schorer said. “We have made significant progress over
the past year and are focused on continuous improvement to the
quality management system.”
“We are committed to ensuring EndoBarrier is available for our
patients and clinicians.”
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 concerning
our expectations regarding the effect of the CE mark suspension,
our ability to resolve nonconformance issues to the satisfaction of
our notified body, and the timing of any reinstatement of our CE
mark. 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 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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version on businesswire.com: http://www.businesswire.com/news/home/20170517006431/en/
GI Dynamics, Inc.Investor RelationsUnited States:Janell
Shields, +1-781-357-3246Investor
Relationsinvestor@gidynamics.comorMedia RelationsUnited
States:Nicole Franklin, +1-617-657-1312nfranklin@jpa.com
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