GI Dynamics Lines Up $52M For Key U.S. Study
Summary
Today, GI Dynamics took one step closer to that goal by raising enough cash to support a big clinical trial in the U.S. GI Dynamics is raising $57.5 million in Australian dollars (A$), or about $52.2 million in U.S. dollars, through a private placement of Chess Depository Interests, or CDIs, a type of security that enables international companies to trade on the Australian exchange.GI Dynamics will use the cash to march the EndoBarrier, the name for its intestinal liner, through a pivotal clinical trial in the U.S.—the last study it needs to carry out before it can win FDA approval.The EndoBarrier is a two-foot-long, tube-shaped, flexible liner inserted into the GI tract that is meant to block a portion of the intestine from absorbing the nutrients and calories in food.A doctor inserts the tube into a patient’s mouth via an endoscopic procedure designed to be less invasive than gastric bypass surgery, in which the GI tract is rearranged.GI is enrolling patients between the ages of 21 and 65 who have a body mass index of between 30 and 50, have uncontrolled type 2 diabetes, and currently use either metformin or sulfonylurea or a combination of the two but can’t keep their blood sugar levels in check.