be removable. Plans are to ask the FDA next year to begin a large U.S. pivotal trial that will hopefully lead to permission to sell the EndoBarrier to a market hungry for weight-loss and diabetes-control treatments.
More than a third of American adults are obese, which can lead to multiple other conditions such as diabetes, cancer, and heart disease. Meantime, the number of adults in the U.S. with diabetes is 23.5 million.
The potential for the EndoBarrier to treat both these U.S. health problems with a simple 20-minute procedure could make it a big winner. In February, there were reports that GI Dynamics’ venture backers provided the startup with an additional $15 million in venture capital to continue development of its technology; that brings the total that investors have now pumped into the company to more than $60 million since its launch in 2003. Still, the company will need to raise additional cash to complete its expected U.S. clinical trial needed for FDA approval, Levine says.
Levine, a former engineer at medical devices firms such as Natick, MA-based Boston Scientific (NYSE:[[ticker:BSX]]), was the founding CEO of GI Dynamics and is one of the main inventors of the small firm’s technology.
