Weight loss: GI Dynamics CEO says FDA decision could speed up U.S. launch

Thu, 08/23/2012 - 3:22pm
Mass Device

GI Dynamics CEO Stuart Randle tells that the FDA's decision to let the company jump to a pivotal trial for its EndoBarrier weight loss device could speed up the medical device company's commercial launch in the U.S.


A clearly elated Stu Randle told today that the FDA's decision to allow GI Dynamics (ASX:GID) to skip directly to a pivotal trial for its EndoBarrier gastrointestinal liner represented a "huge milestone" for the medical device company.

GID announced earlier that the company won conditional FDA approval for a U.S. pivotal clinical trial of the EndoBarrier in treatment of diabetes and obesity, skipping the pilot trial process, a move the CEO of the Lexington, Mass.-based company said could help speed up a U.S. launch.

"This is something we were hopeful for and we're thrilled with the outcome," Randle told us in a telephone interview.


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