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| GI Dynamics is teaming with Medtronic and GlaxoSmithKline to further investigate its EndoBarrier implant--courtesy of GI Dynamics |
GI Dynamics ($GID) is in the midst of a pivotal trial to get FDA approval for its EndoBarrier device, and now the company has inked deals with luminaries in devices and drugs to flesh out how the anti-obesity tech could help diabetics.
GI has signed on with Medtronic ($MDT) to research how the device affects continuous glucose levels and entered a separate arrangement with GlaxoSmithKline ($GSK) to investigate hormonal changes in patients implanted with EndoBarrier.
Founder and Chief Technology Officer Andy Levine said the big-name deals speak to EndoBarrier's promise and could lead to future team-ups.
"We expect these collaborations will lead to a better understanding of the [mechanism of action] of EndoBarrier and may lead to improvements in the device, as well as potential combinations of drug treatment and EndoBarrier therapy to optimize patient outcomes," Levine said in a statement.
GI got the FDA's blessing for a pivotal trial back in October, planning to enroll 500 patients to test its tube-shaped weight-loss device, which is implanted non-surgically with an endoscope. EndoBarrier has paced a quick trek through the stateside regulatory process, getting an FDA waiver on a pilot trial and moving right into the pivotal phase, progressing well ahead of the company's internal schedule, CEO Stuart Randle has said.
GI touts the device as capable of rapidly and dramatically reducing blood sugar levels in patients and spurring 20% weight loss in the first year after implantation. The device got its CE mark back in 2010 and is commercially available in countries around Europe and Latin America.
- read the statement
Correction: An earlier version of this story misstated when GI Dynamics got FDA approval for its pivotal trial. We regret the error.