Weight loss: GI Dynamics CEO says FDA decision could speed up U.S. launch
GI Dynamics CEO Stuart Randle tells MassDevice.com 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 MassDevice.com 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.