GI Dynamics (ASX:GID) said today that Australia’s Therapeutics Goods Administration removed the EndoBarrier weight loss device from the Register of Therapeutic Goods, effectively stopping commercialization of the device in the region.
The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract to treat Type II diabetes and obesity.
The Lexington, Mass.-based company received notification of the delisting in September, based on a lack of “adequate evidence of compliance with certain provisions of the TGA Essential Principles,” which it was asked to supply within 20 working days.
“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,” GI Dynamics wrote in an SEC Filing.
The delisting went into effect October 12, the company said, restricting the device to use in approved trials only. The company said it will not be appealing the decision.
GI Dynamics said it will continue to support ongoing trials, including a randomized, controlled trial exploring the treatment of nonalcoholic steatohepatitis which has been enrolling patients for 14 months.
“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,” prez & CEO Scott Schorer said in a press release. “We look forward to supporting Professor Holtmann and his colleagues in his critical research of a disease state (NASH) that has no current treatment.”
GI Dynamics said its sales in Australia constituted approximately 15% of its worldwide revenue.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.