GI Dynamics, Inc., developer of the EndoBarrier® insertable sleeve for treatment of obesity and type 2 diabetes, has seen its product suspended from European marketing by its notified body. The news comes on the back of third quarter financials in which revenues are estimated to be between $550,000 and $575,000 a decrease from the Q2 2014 revenues of $840,000.
Background
A frequent visitor to our pages over the past few years, EndoBarrier is the first endoscopically-delivered device therapy approved and commercially available in multiple countries outside the U.S. for the treatment of type 2 diabetes and/or obesity.
GI Dynamics has announced that its European Notified Body has temporarily suspended commercial product shipments labeled with a CE Mark affecting all countries where the Company is currently selling EndoBarrier®, pending a review of its vigilance and reporting systems.
The company is keen to point out that the action 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. Indeed it plans to continue its ongoing clinical trial activities, including the ENDO Pivotal Trial currently underway in the United States.
Predictably enough, the news that GI Dynamics’ quality system had serious deficiencies, coupled with a less than rosy sales picture, contrived to see the company’s share price endure a pretty dramatic fall, closing at about half its June high.
Company comments
Michael Dale, the Company’s president and Chief Executive Officer, said, “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, 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.”
Source: GI Dynamics, Inc.
published: October 10, 2014 in: Gastroenterology, Regulatory