GI Dynamics (ASX:GID), in its first earnings release as a publicly traded firm, said it’s hoping to start a U.S. clinical trial of its EndoBarrier weight-loss and diabetes device this year.
The Lexington, Mass.-based company posted losses of $26.4 million, or $1.29 per share, on sales of $234,000 for the year ended Dec. 31, 2011.
GI Dynamics went public in September 2011, netting nearly $80 million (A$74 million) in an initial public offering on the Australian stock exchange. The company said it had about $66 million in the bank at the end of the year.
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“In the United States, the company is engaged in conversations with the FDA to further define its U.S. clinical program. Following the conclusion of these conversations, the company expects to begin a clinical study of the EndoBarrier in the U.S. later this year,” according to a press release.
CEO Stuart Randle said the company is focused on adding to its roster of “Centers of Excellence” for the EndoBarrier procedure.
“Having established a solid commercial foundation in 2011 upon which to build, we are well positioned to continue to advance our sales and business objectives in 2012 and expect to have approximately 30 Centers of Excellence established by year-end,” Randle said in prepared remarks.
The EndoBarrier is a plastic gut-lining sleeve that hangs from the outlet of the stomach and lines the small intestine. It’s designed to slow the uptake of nutrients to effect weight loss, and has been shown in small clinical trials to also mitigate the symptoms of diabetes. It’s on the market in the U.K., Netherlands, Austria, Germany and Chile; GI Dynamics said it’s planning to begin sales in “a select number of new countries,” including Australia, some time in 2012.
