GI Dynamics has ambitious plans to gain regulatory approvals to treat two global epidemics—obesity and type 2 diabetes—with its experimental intestinal liner. The reversible, minimally invasive procedure to place the device in patients could appeal to an even wider market than permanent surgeries such as gastric bypass that are currently popular options.
The Lexington, MA, medical devices startup unveiled significant results from a pilot study of its liner in patients with type 2 diabetes this week. (Check out Luke’s story on the trial, which showed that the so-called EndoBarrier device dramatically reduced blood sugar levels.) But GI Dynamics CEO Stuart Randle says that the first major health problem the company aims to tackle with the device is obesity. Randle also detailed how the firm, which has remained somewhat quiet during its five-odd years in operation, has convinced some of the best-known venture capitalists in the Boston area to bet on the potential of the EndoBarrier.
The EndoBarrier is a two-foot long, flexible sleeve designed to limit absorption of calories and nutrients by physically blocking food from coming in contact with a segment of the small intestine. Using endoscopic tools, doctors can slip the device into place via a patient’s mouth; to remove the liner they essentially reverse the procedure. (For more details on the device, here is a list of U.S. patents assigned to the company.) Given that there are about 24 million American diabetics and some 70 million obese Americans, GI’s technology could tap huge markets worth billions of dollars.
“I think the bottom line is we are very excited about where we are,” Randle says. “We have a single technology that we can apply to two global epidemics in obesity and diabetes. We’re going to continue to expand our clinical trials and continue moving forward.”
Within the next few months, Randle says, the company plans to begin further studies, outside the U.S., of EndoBarrier for weight loss. He adds that the firm plans to have discussions with the FDA in the next year about the design of a pivotal clinical trial of the device for that indication. As is typical in the medtech business, the firm expects to gain a CE Mark for European marketing clearance before the FDA gives it a green light to begin sales in this country.
And what about all those folks here and abroad who aren’t considered obese but would like to lose some weight anyway, I asked Randle, will the company seek approval for the device to be marketed to them? “We expect that we will. We will work with the regulatory agency to work on that,” he said, though he … Next Page »
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