MIMEDX Receives Regulatory Approval to Commercialize EPIFIX® in Japan
June 08, 2021 at 08:30 am EDT
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MIMEDX Group, Inc. 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.
MiMedx Group, Inc. is a placental biologics company. The Company is engaged in developing and distributing placental tissue allografts with patent-protected, processes for multiple sectors of healthcare. Its product portfolio categories include Wound Care Products, and Surgical and Other Products. Its Wound Care Products include EPIFIX, EPICORD and EPIEFFECT, which are all marketed for external use, such as in advanced wound care applications. Its Surgical and Other product offering includes AMNIOFIX, AMNIOCORD and AMNIOEFFECT, which are positioned for use in a variety of applications and surgical settings, including lower extremity repair, plastic surgery, vascular surgery and multiple orthopedic repairs and reconstructions. The Company's platform technologies include tissue allografts derived from the human placental membrane, tissue allografts derived from the human umbilical cord, and a particulate extracellular matrix derived from the human placental disc.