TGA Cancellation of EndoBarrier Listing
GI Dynamics, Inc. (ASX: GID) (GI Dynamics or the Company), a medical technology company that has developed an innovative device to improve outcomes for patients diagnosed with type 2 diabetes and obesity, has received final cancellation notification from the Therapeutic Goods Administration (TGA) for the listing of EndoBarrier on the Australian Register of Therapeutic Goods (ARTG).
On September 12, 2016, the TGA notified GI Dynamics that it would cancel the EndoBarrier listing on the ARTG. The TGA stated that the Company failed to provide adequate evidence of compliance with certain provisions of the TGA Essential Principles within the required 20 working days.
As previously communicated, the cancellation of EndoBarrier from the ARTG took effect on October 12, 2016. As a result, the Company will not be permitted to supply the EndoBarrier device in Australia for use outside of approved trials. The Company will not be appealing the decision.
This action does not constitute a recall, nor is this action a result of any direct safety concerns associated with the utilization of EndoBarrier. All implanted patients may continue therapy subject to ongoing evaluation and monitoring by their healthcare professionals.
In addition, enrollment will be allowed to continue for a current ongoing randomized controlled trial that has been enrolling for 14 months. The trial is authorized per clinical trial design and approval by the local ethics committee, as well as the Australian New Zealand Clinical Trials Registry. The trial is focused on Nonalcoholic Steatohepatitis (NASH), led by Professor Holtmann, MD from Princess Alexandria Hospital in Brisbane, Australia.
GI Dynamics will continue to support the ongoing trial. In addition, GI Dynamics will continue to support patients and clinicians to help provide for safe removal of all EndoBarrier implants at the date specified by the treating clinicians.
Revenue derived from EndoBarrier units sold in Australia constitutes approximately 15% of GI Dynamics’ worldwide revenue.
“We will continue to provide clinical support to the patients and clinicians who utilized EndoBarrier to ensure that we achieve safe treatment and removal of the devices,” stated Scott Schorer, GI Dynamics president and CEO.
“We look forward to supporting Professor Holtmann and his colleagues in his critical research of a disease state (NASH) that has no current treatment.”