GI Dynamics (ASX:GID) sealed a deal with CMS Medical to distribute its EndoBarrier weight loss and diabetes device in Brazil, hoping to hit the market there by early 2014.
The deal will have to wait until the EndoBarrier is formally approved by the Agência Nacional de Vigilância Sanitária, Brazil’s regulatory agency. Following that regulatory green light, CMS Medical will be the exclusive distributor of the EndoBarrier in the Carioca State. CMS Medical is currently working with a sister company, SciTech Medical, to make sure the EndoBarrier sails through ANVISA’s approval process, according to a press release.
"We are very pleased to establish this partnership with SciTech and CMS, with the combined entity being recognized as a premier distributor and manufacturer of minimally-invasive medical products in Brazil," chief commercial officer Mark Twyman said in the release. "Their proven track record of bringing innovative healthcare solutions to physicians throughout Brazil, coupled with their knowledge and understanding of the ANVISA registration process will be invaluable as we work toward regulatory approval and commercialization in this market."*
The EndoBarrier is inserted through the mouth into the stomach lining, acting as a physical wall between food and the intestines. It’s been shown to lower blood glucose levels and has been approved in several countries outside the U.S.
GI Dynamics recently published positive results from a study of the effects in mildly obese patients. Last month the product hit the market in Israel, and in January the Lexington, Mass.-based company launched a pivot trial in the U.S. in the pursuit of pre-market approval.
*Correction, march 12, 2013: This article originally identified Mark Twyman as GI Dynamics’ chief technology officer. Twyman is the company’s chief commercial officer. Return to the corrected sentence.