Business
MIMEDX EPIFIX® Receives Reimbursement Approval in Japan
Provides Favorable Access to a New $500 Million Market for the Treatment of Refractory Diabetic and Venous Ulcers for EPIFIX – the First and Only Amniotic
About this update from Mimedx Group, Inc
[{"type":"text","content":"Provides Favorable Access to a New $500 Million Market for the Treatment of Refractory Diabetic and Venous Ulcers for EPIFIX – the First and Only Amniotic Tissue Product Approved for Use in Japan MARIETTA, Ga., Sept. 12, 2022 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), a transformational placental biologics company, today announced that the Japanese Ministry of Health, Labour and Welfare (JMHLW) approved reimbursement of EPIFIX® to treat refractory or hard-to-heal lower extremity diabetic and venous ulcers. The Company is in the last stages of preparing for full product launch, anticipated in the fourth quarter. The Company estimates the Japanese total addressable market associated with the scope of the JMHLW reimbursement decision to be approximately $500 million based on a recently completed third party market study. The study estimated that there are more than 400,000 hard-to-heal wounds that present each year in Japan that can be treated by EPIFIX and which qualify for reimbursement under the JMHLW’s decision. “Achieving reimbursement was a key pre-requisite to launch EPIFIX in Japan, and we think the awarded rate of 35,100 Yen/cm2 will be very favorable in supporting market adoption,” said Rohit Kashyap, Ph.D., MIMEDX President, Wound Care & Surgical. “We view the Japanese market as a meaningful new stream of future revenue. With this positive reimbursement decision now secured, we are moving quickly to finalize our launch sequence, which includes completing distributor agreements and training, gaining local patient experience, and building market awareness. We have been very encouraged by early physician interest and are well positioned to penetrate the market leveraging the strength of our clinical and economic data, established Key Opinion Leader relationships, and strong local society support.” Dr. Hiroto Terashi, Chief Professor in the Department of Plastic Surgery at Kobe University, Chairman of the Japanese Society for Foot Care and Podiatric Medicine and Chairman of the Japan Society for Surgical Wound Care, said, “Physicians need products that are clinically effective in wound closure and that can prevent complications such as infection, wound recurrence, surgical intervention, and amputation. I am very excited to have reimbursement acceptance for EPIFIX in Japan, and I believ...