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.
GI Dynamics said that yesterday it received “formal notification from the TGA” that the device’s clearance had been cancelled and that the company will not be permitted to supply the device in Australia.
Lexington, Mass.-based GI Dynamics said in a regulatory filing that it received notice that the “inclusion of the EndoBarrier device on the Australian Register of Therapeutic Goods (ARTG) may be cancelled” earlier this week.
The company said it has been in “ongoing communication” with the TGA over compliance-related matters, and has submitted all information as requested.
The notice comes a month after the company said it’s hoping to make another run at FDA approval for the flagship EndoBarrier after its 1st try failed last year.
In a presentation accompanying the release of its 2nd-quarter numbers, the medical device company said it’s busy repairing its relationship with the FDA and plans to finalize a bid for another investigational device exemption during the 1st half of 2017; GI Dynamics said it hopes to begin enrollment in the IDE trial by the end of June 2017.
A higher-than-expected rate of liver abscesses forced the halt of a U.S. trial last year.
The company managed to pare its Q2 losses despite a more than 50% top-line plunge, thanks in part to a 30% workforce cut initiated by new CEO Scott Schorer, a medical device veteran with stints as an executive or advisor at a raft of companies under his belt. Losses were down -62.0% to -$3.9 million, or -41 per share, on sales of $132,000 for the 3 months ended June 30, compared with the same period last year.