MiMedx (Marietta, Ga.) recently received regulatory approval from the Therapeutics Goods Administration in Australia to market its dehydrated Human Amnion/Chorion Membrane products. The approval includes the company’s EpiFix, AmnioFix, EpiBurn, AmnioFix Injectable and AmnioFix Wrap.
MiMedx’s product line approval allows the company to market, distribute and sell its products to physicians to help treat patients with wound care, surgery, sports medicine and pain management.
“This regulatory approval in Australia marks another commercial milestone for MiMedx as we continue to expand our global footprint,” Christopher Cashman, executive VP and chief commercialization officer at MiMedx, said in a press release. “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.”
AmnioFix and EpiFix grafts are now able to be marketed for the treatment of acute and chronic wounds to enhance healing. AmnioFix Sports Med and AmnioFix Injectable were both approved to be used for the treatment of chronic plantar fasciitis.
“As a prerequisite to the approval process, MiMedx received a Certificate of Good Manufacturing Practice Compliance from the TGA, indicating that all of our sites comply with the requirements of the Australian Code of GMP for human tissue products,” Cashman said. “This is similar to the GMP requirements in the United States, and further validates the quality of our processing and manufacturing systems and procedures.”
MiMedx has also recently partnered with LifeHealthcare Group to enter the Australian market.
“We have been building our international presence over the last several years. Given the complexity of the regulatory process for human tissue in certain regions outside the U.S., it can take years to get through the regulatory approval and reimbursement process,” John Harris, senior VP of international at MiMedx, said. “We receive regular and strong interest from clinicians and caregivers in numbers international regions, and we remain committed to our long-term strategy of building a presence for MiMedx products outside of the U.S.”
