MIMEDX Group Inc., an industry leader in utilizing amniotic tissue as a platform for regenerative medicine, has 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 where they live,” said Stan Micek, MIMEDX senior vice president, business development and international. “We are extremely pleased with JMHLW’s decision to grant Shonin approval for EPIFIX, and we are glad to be one step closer to bringing EPIFIX to market in Japan. Our focus will now shift toward obtaining appropriate reimbursement and establishing logistical and distribution networks for commercialization, which we hope will result in full availability of EPIFIX in the 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. Once a reimbursement pricing policy is approved and the reimbursement rate is listed, the Company can begin offering EPIFIX to patients and providers in Japan.
 
Timothy R. Wright, MIMEDX CEO, commented, “EPIFIX can only benefit patients with hard-to-heal wounds if they can access its life-improving properties, and regulatory approval is a significant milestone in addressing unmet need for people in Japan. With today’s announcement, EPIFIX now has the potential to reach as many as 100,000 additional patients each year. This critical step helps us fulfil our mission of bringing advanced regenerative medicine to suffering patient populations and is important in the Company’s global expansion.”