Under the deal, CMS will distribute GI Dynamics’ EndoBarrier therapy in Brazil, upon the regulatory approval of the product by Agencia Nacional de Vigilancia Sanitaria (ANVISA).
The EndoBarrier device, which is delivered endoscopically during a non-surgical procedure, acts as a physical barrier between food and treats patients who have uncontrolled type 2 diabetes and are obese.
Previously, the device has shown to lower HbA1c (blood glucose) to healthy levels and achieve weight loss of approximately 20% within one year.
To help manage the regulatory process, GI Dynamics is collaborating with CMS’ sister company SciTech Produtos Medicos.
SciTech co-founder Melchiades da Cunha Neto said, "We are excited to be working with GI Dynamics and look forward to leading the commercialization of EndoBarrier Therapy following ANVISA approval."
GI Dynamics chief commercial officer Mark Twyman said, "If all goes well, we expect to launch EndoBarrier Therapy in Brazil in early 2014."
The company said, EndoBarrier Therapy which is available in Europe, Australia, Chile and Israel, has initiated a pivotal ENDO clinical trial of the device in the US.
