GI Dynamics (ASX:GID) said Swiss and German regulators took the 1st steps toward reimbursement in those countries for its EndoBarrier weight loss and diabetes device.
Lexington-Mass.-based GI Dynamics said the German Institute of Medical Documentation & Information granted preliminary codes for the EndoBarrier to treat Type II diabetes and/or obesity. In Switzerland, the Federal Office for Statistics published a unique code for EndoBarrier implantation, according to a press release.
"The designation and implementation of these codes allow government authorities to track costs and align reimbursement codes for EndoBarrier therapy," according to the release. "Once data on a sufficient number of EndoBarrier procedures have been accumulated, these will be evaluated and the company expects that the codes will be mapped to procedure codes and costs consistent with EndoBarrier therapy."
"These designations represent the next, vital step to achieving appropriate reimbursement at the national level," president & CEO stated Stuart Randle added in prepared remarks. "EndoBarrier therapy continues to gain interest and traction among physicians, patients, health insurers and government agencies, as demonstrated by this recent action by the German and Swiss health authorities. These actions confirm our strategy to invest and commercialize in reimbursed markets, and we look forward to continued growth and activity in these markets."
Earlier this summer, French authorities agreed to fund a trial examining the cost and utility of the device as part of a government program to evaluate reimbursement policies for devices already on the shelves.
The EndoBarrier won CE Mark approval in the European Union in 2010. GI Dynamics launched a U.S. trial of the EndoBarrier device in January to back a pre-market approval application with the FDA. Clinical trial results released in February showed that the EndoBarrier helps control blood sugar in "mildly obese" patients with Type II diabetes.
The device is a plastic sleeve designed to line the gut to prevent the absorption of nutrients from food.
