GI Dynamics is looking to raise between $80 to $95 million (AUS), which is about $86 million to $102 million (USD), through an initial public offering in Australia.
The company filed a prospectus with Australian regulators this morning, although shares will not be issued until Aug. 11, 2011, according to the filing.
Dan Budwick, spokesman for the Lexington, Mass.-based device maker told MassDevice that the company was "in a quiet period in the U.S. and cannot comment at this time."
GI Dynamics’ EndoBarrier gastrointestinal sleeve won Australian approval for treatment of type 2 diabetes and obesity just last week. The device won CE Mark in Dec., 2009, for six months of treatment, which prompted a $15 million investment from Minneapolis, Minn.-based medical device giant Medtronic Inc. (NYSE:MDT), which joined other investors in backing the firm as it prepared for commercial launch in the European Union.
The Endobarrier has since been approved for 12 months of treatment in the European Union, and is commercially available in Chile, Germany, the United Kingdom and the Netherlands. The company has also received an investigational device exemption approval to commence a pilot trial of the EndoBarrier in the United States.
The EndoBarrier is a plastic sleeve inserted endoscopically into the small intestine, where it slows the uptake of nutrients from food to induce weight loss and help control the symptoms of diabetes.
The device can be implanted without surgery, which company president & CEO Stuart Randle views as the next wave for medical devices. "I think the next generation of technologies is going to be combinations of devices, combinations of drugs and combinations of devices and drugs, all focused on effecting multiple mechanisms of action simultaneously — and less invasively than surgery," Randle told MassDevice in a June 2009 interview.
A series of clinical studies in 2009, as well as more recent research, has showed that patients treated with the EndoBarrier reduced their average blood glucose levels and lowered other diabetic factors including fasting blood glucose, and morbidly obese patients lost significant amounts of weight.