Business Expanding MIMEDX, the largest manufacturer of therapeutic biologics in the U.S. and a leader in the field of advanced wound care, establishes a Japanese subsidiary in Tokyo

Dec 12, 2022

MIMEDX Group, Inc.External site: a new window will open. is a U.S. manufacturer of therapeutic biologics that develops and markets human placental-based tissue allografts for wound care, burns, and various surgery applications to promote healing and reduce inflammation. Since its establishment in 2008, the company has supplied more than 2.5 million allografts in the United States as a pioneer in human placental tissue engineering.

Establishment
2021/08
Destination
Tokyo

  • Biotechnology & Lifescience
  • USA

On June 7, 2021, the company's “EPIFIX” dehydrated human amnion/chorion membrane allograft received Japan’s regulatory approval as the first material using human amniotic membrane to facilitate tissue healing in Japan, and became covered by health insurance on September 1, 2022. This product is classified as a class IV (highly controlled medical device) and “Specified Biological Product,” and is used for the treatment of hard-to-heal chronic wounds such as diabetic ulcers (DFU) and venous leg ulcers (VLU) that do not respond to conventional therapy. Insurance coverage for EPIFIX can provide doctors and patients with new treatment options and optimal wound care. It is sold in more than 20 countries around the world, including the United States, Australia, and other countries in Europe, the Middle East, and Asia.

The company has positioned Japan as an important market and established MiMedx Japan, Godo Kaisha in Tokyo in August 2021 with the purpose of entering the market. It is currently preparing for the start of full-scale sales.

To assist with the company’s market entry to Japan, JETRO's Invest Japan Business Support Center (IBSC) provided consultation on incorporation (registration, taxation and labor), market information, regulatory and institutional information, PR support, and it also introduced service providers (real estate companies).

“EPIFIX” dehydrated human amnion/chorion membrane allograft

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