GI Dynamics (ASX:GID) earned a thumbs-up from the Israeli Ministry of Health for its EndoBarrie device to treat obesity and Type II diabetes.
Lexington, Mass.-based GI Dynamics said it’s engaged \Lavi-Medical Agencies as exclusive distributor for the EndoBarrier in Israel, where Sheba Medical Center at Ramat-Gan is currently the only hospital offering the device.
The EndoBarrier is plastic sleeve that lines the small intestine to prevent the uptake of food. Originally designed to treat obesity, the device has shown in clinical trials that it can help control the symptoms of Type II diabetes.
"Our 1st patient cases in Israel mark yet another milestone in the global commercialization of EndoBarrier therapy," chief commercial officer Mark Twyman said in prepared remarks. "In the coming months, we will continue to cultivate and train additional centers in Israel and work closely with our distributor to provide EndoBarrier therapy to the many patients living with uncontrolled Type II diabetes and obesity."
The EndoBarrier is already on the market in Europe, Chile and Australia. In the U.S., GI Dynamics won conditional FDA approval to skip pilot trials, using clinical data from former trials for a pivotal trial announced last month.
That study will span 25 states and enroll 500 obese patients. President & CEO Stu Randle told MassDevice.com at the time that the company hopes to submit pre-market approval to the FDA by late 2015.
