MDXG - Mimedx's Epifix secures regulatory approval in Japan

Mimedx Group (MDXG) announces successful regulatory approval by the Japanese Ministry of Health, Labour and Welfare ((JMHLW)) to market Epifix in Japan. Epifix - a bioabsorbable, human amniotic membrane allograft, is applied to affected areas for wound healing.The product uses proprietary methods, including the Purion process, to provide a semi-permeable, protective barrier that supports the healing cascade. Th company submitted a Shonin (pre-market approval) to Japanese regulatory agencies in mid-2020. EPIFIX was approved for hard-to-heal chronic wounds, such as diabetic foot ulcers and venous leg ulcers, which do not respond to conventional therapy.EPIFIX will be classified as a Class IV Medical Device and “Specified Biological Product” under JMHLW guidelines. Epifix is expected to be fully available in Japanese market in early 2022. The Company is currently working with JMHLW to establish reimbursement pricing, a process expected to take up to six months.

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Mimedx's Epifix secures regulatory approval in Japan