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MIMEDX Receives Regulatory Approval to Commercialize EPIFIX® in Japan
Availability of EPIFIX Allografts Expected Early 2022 Approval Makes it Possible to Bring EPIFIX’s Healing Properties to as Many as 100,000 New Patients
About this update from Mimedx Group, Inc
[{"type":"text","content":"Availability of EPIFIX Allografts Expected Early 2022 Approval Makes it Possible to Bring EPIFIX’s Healing Properties to as Many as 100,000 New Patients Annually MARIETTA, Ga., June 08, 2021 (GLOBE NEWSWIRE) -- MIMEDX Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), an industry leader in utilizing amniotic tissue as a platform for regenerative medicine, today announced 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. EPIFIX protects the wound bed to aid in the development of granulation tissue and delivers a human biocompatible extracellular matrix that retains 300+ regulatory proteins. MIMEDX submitted a Shonin (pre-market approval) to the JMHLW, Japan’s primary regulatory body for creating and implementing safety standards for drugs and medical devices, and the Pharmaceutical and Medical Device Agency (PMDA), an independent administrative agency that works with JMHLW to ensure the safety and quality of drugs and medical devices, in mid-2020. EPIFIX was approved for hard-to-heal chronic wounds, such as diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs), which do not respond to conventional therapy. EPIFIX will be classified as a Class IV Medical Device and “Specified Biological Product” under JMHLW guidelines. Dr. Hiroto Terashi, Chief Professor in Department of Plastic Surgery at Kobe University, Chairman of the Japanese Society for Foot Care and Podiatric Medicine (JFCPM), and Chairman of the Japan Society for Surgical Wound Care (JSSWC) said, “As a plastic surgeon and wound care physician for my entire career, I am delighted with EPIFIX’s approval in Japan. EPIFIX will greatly expand treatment options for chronic wounds caused by lower extremity venous and diabetic ulcers in patients in Japan, providing opportunities for increased limb salvage.” \"Diabetic foot ulcers and venous leg ulcers that are unable to heal on their own pose a serious long-term health risk to people around the world. Our vision is to provide access to EPIFIX technology that can change people’s lives, no matter w...