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GI Dynamics completes AUS$57.5 million funding

Company to use revenues to finance The ENDO Trial

GI Dynamics has raised AUS$57.5 million in its latest round financing. The company plans to use the proceeds to fund The ENDO Trial its US pivotal clinical trial and for general working capital purposes.

“We are very pleased with the successful completion of this financing,” said Stuart A Randle, chief executive officer of GI Dynamics. “This financing allows us too fully and rapidly resource our pivotal trial (The ENDO Trial) in the United States while continuing to expand our commercial footprint and sales ramp in Europe, Australia, South America and the Middle East and build the case for reimbursement in key markets.”

The multi-centre, pivotal clinical trial of the EndoBarrier (GI Dynamics), the ENDO Trial, started in the US in January 20123. The study, which was approved by the FDA in October 2012, is investigating the EndoBarrier’s efficacy in treating obese patients who have uncontrolled type 2 diabetes.

The ENDO trial is a randomised, double-blind, sham-controlled trial, which will enrol approximately 500 people with uncontrolled diabetes at 25 sites in the US. The trial is designed to assess improvements in patients’ diabetes during a study period of up to 12 months.

The primary endpoint for the trial is an improvement in patients’ HbA1c levels. Secondary endpoints include weight loss and improvements in some cardiovascular risk factors.

The trial is an important step in the company’s bid to secure marketing approval for the EndoBarrier in the US. Data gathered during the trial will be used to support a premarket application for the device. If this is approved, GI Dynamics will be able to market the device in the US.

The device has already been approved for marketing in Australia and the EU.

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