MiMedx Group Announces U.S. Court Issues Favorable Ruling In Co.'s Litigation Against FDA's Regulatory Classification Of AXIOFILL

MiMedx Group, Inc. (Nasdaq: MDXG) ("MIMEDX" or the "Company") today announced that the U.S. District Court for the Northern District of Georgia issued a favorable ruling in the Company’s litigation challenging the U.S. Food and Drug Administration’s ("FDA") regulatory classification of AXIOFILL, the Company’s human placental-derived extracellular matrix particulate product.

The Court vacated FDA’s determination that AXIOFILL is not a Section 361 HCT/P because it is more than minimally manipulated and FDA’s determination that AXIOFILL should be classified as a biological product rather than a medical device. The Court remanded both matters to FDA for further consideration consistent with its order.