MiMedx announces regulatory approval to commercialize products in Australia
MiMedx announced that it received regulatory approval from the Therapeutics Goods Administration in Australia to market and sell a broad array of the company's dehydrated Human Amnion/Chorion Membrane products. This includes EpiFix, AmnioFix, EpiBurn, AmnioFix Injectable, and AmnioFix Wrap, among others. MiMedx products are classified as a Biological in Australia and are regulated by the TGA, a part of the Australian Government Department of Health that is responsible for regulating the import, supply, manufacture, export and advertising of therapeutic goods. The approval of the company's products enables MiMedx's local partner to market, distribute and sell the breadth of its capabilities to serve physicians and help treat their patients in the areas of wound care, surgery, sports medicine and pain management. Christopher Cashman, MiMedx EVP and Chief Commercialization Officer, said, "The approval of our EpiFix and AmnioFix product lines by the TGA is an important step in ensuring that Australian patients are able to gain access to innovative products in a timely manner. We look forward to formally launching our products in that market."