OrthogenRx develops and commercializes class-III orthopedic medical devices.
OrthogenRx Inc. is a late-stage, product-development company focused on the commercialization of class-III orthopedic medical devices. Its business model is to obtain exclusive licenses for products currently on the market outside the United States and seek FDA regulatory approval through a novel regulatory pathway. OrthogenRx is positioned by the end of 2014 to be the first company to obtain an approval for a generic Class III medical device using this pathway. The Company will launch it’s first product in early 2015 and file for 2-3 additional product approvals by the end of 2015.