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| Courtesy of GI Dynamics |
GI Dynamics is planning a big entry into the massive Brazilian market with its non-surgical device to treat Type 2 diabetes and obesity. And it will use a local distributor to accomplish this: Brazil's CMS Medical. Before that point however, Brazilian regulatory authorities must approve EndoBarrier, and GI Dynamics has that covered, too. The company submitted its registration application for the product to the regulatory agency ANVISA, and a CMS sister company will help manage the regulatory process. If all goes according to plan, EndoBarrier will launch in Brazil in early 2014. Meanwhile, the company is pursuing a U.S. clinical trial for Endobarrier with an eye toward a 2015 FDA regulatory submission. Release