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Endobarrier

GI Dynamics suspends shipments of EndoBarrier

The suspension of shipments is not a product recall and does not apply to product currently owned by hospitals or distributors, or product required for use in clinical trials
The company’s securities have been placed in Trading Halt Session State at its request

GI Dynamics has been informed by its Notified Body in the European Union (an organisation that has been accredited by a Member State to assess whether a product meets certain preordained standards), that it has temporarily suspended commercial product shipments labelled with a CE Mark affecting all countries where it is currently selling EndoBarrier, pending a review of its vigilance and reporting systems.

The suspension of shipments is not a product recall and does not apply to product currently owned by hospitals or distributors, or product required for use in clinical trials. GI Dynamics plans to continue its ongoing clinical trial activities, including the ENDO Pivotal Trial currently underway in the US.

 “The company is working diligently with our Notified Body and with Competent Authorities in Europe to remedy our systems and resume product shipments as soon as possible,” said Michael Dale, the company’s president and CEO, “However based on the current schedule established for review of our systems, we do not expect resolution of the stop shipment before end of October.”

The company’s securities have been placed in Trading Halt Session State at its request, pending the release of further announcements by the company. The securities will remain in Trading Halt Session State until the earlier of the commencement of normal trading on Wednesday 8 October 2014 or when the announcement is released to the market.

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