Gunze launches Dehydrated Human Amnion/Chorion Membrane (dHACM) Allografts for wound care, the first and only approved product in Japan, through its subsidiary “Gunze Medical“
News
Gunze launches Dehydrated Human Amnion/Chorion Membrane (dHACM) Allografts for wound care, the first and only approved product in Japan, through its subsidiary “Gunze Medical“ A novel approach to refractory ulcers not responding to conventional therapies, leading to a better patient outcome
Osaka-Gunze Limited (Headquarters: Osaka, Japan, President: Toshiyasu Saguchi)[TOKYO: 3002] is pleased to announce that a subsidiary “Gunze Medical limited” will start selling EPIFIX®, Dehydrated Human Amnion/Chorion Membrane (dHACM) Allografts, as the first and only approved product in Japan on February 1, 2023. *EPIFIX® is a registered trademark of MIMEDX Group, Inc. (Georgia, USA).
Background of sales launch
MIMEDX received regulatory approval for EPIFIX by the Japanese Ministry of Health, Labor and Welfare (JMHLW) in June 2021 and reimbursement approval in September 2022. EPIFIX is classified as a Class IV medical device and “Specified Biological Product” under JMHLW guidelines. It is the first and only amniotic tissue product approved for use in Japan. MIMEDX has decided to promote the product in the Japanese market with Gunze Medical which has experiences in wound care field over 30 years together making an exclusive distributor agreement.
Features of “EPIFIX”
EPIFIX is a PURION® processed placental tissue allograft that supports the healing cascade by providing a semi-permeable, protective barrier over wounds. The product protects the wound bed to aid in the development of granulation tissue and provides a human biocompatible extracellular matrix that retains 300+ regulatory proteins including extracellular matrix (ECM) proteins, growth factors, and cytokines, which contribute to reducing scar tissue formation, suppressing inflammation, and promoting wound healing. The target indications are approved for the treatment of refractory diabetic foot ulcers (DFU) and venous leg ulcers (VLU) that do not respond to conventional therapies. It is the first human amniotic membrane product in the wound therapy field in Japan. With 2 million units already sold in the U.S. and MIMEDX has the largest share of the U.S. market for human placenta-derived tissue products. Applicable reimbursement conditions are as follows: the wound area must not shrink by more than 50% even after four or more weeks of conventional therapy, the product must be used under inpatient supervision for the first application for each patient, the maximum treatment area must be 224 cm2 from the start of treatment to 12 weeks and per series of treatment plans, and physicians who have attended the EPIFIX course sponsored by the Japanese Society for Foot Care and Podiatric Medicine must be affiliated with the department of podiatry.
EPIFIX® Dehydrated Human Amnion/Chorion Membrane (dHACM) Allografts
Product outline
Product name
EpiFix
Intended use
It is intended for use in refractory ulcers that do not respond to conventional therapies to promote wound healing. 【Precautions】 ・For patients not responding well to conventional therapies for a certain period of time. Conventional therapies include basic wound management (removal of necrotic tissue, infection control, wound cleansing, etc.), blood sugar control for DFU, compression therapy for VLU, and moisture control with wound dressings. ・The application to patients should be considered that conventional therapy for ulcers should be 4 weeks or longer. ・Total applicable area should be kept to the minimum necessary up to 224㎠ based on the evidence of biocompatibility tests.
The number of patients with diabetic foot ulcers in Japan is estimated to be about 250,000 and some undergo lower limb amputation. Gunze Medical, as a specialist in the wound care field, will promote this innovative product to contribute to improvement of patient clinical outcome.
・Sales of medical instruments (Plastic and Reconstructive surgery, Neurosurgery, Oral surgery, Cardiovascular surgery, Cosmetic surgery, Pediatric surgery, Dermatology etc.) ・Consultation for opening medical facilities
Gunze was founded in Kyoto, Japan in 1896, and today operates diverse businesses as a leading developer and manufacturer of Medical Devices, Plastic Films, Engineering Plastics, Electronic Components, Apparel, and various other segments. Gunze employs more than 5,600 people worldwide throughout 10 countries. The Medical Device business, established in 1985, has a substantial footprint in over 35 countries. Its head office and manufacturing facility are located in Kyoto, Japan, and has subsidiaries in the U.S., EU, and China. By applying innovative fiber and polymer processing technologies, Gunze manufactures a comprehensive range of medical products focused on bioabsorbable and biocompatible materials such as skin substitutes, tissue reinforcement felt, bone fixation devices, dural substitutes, and suture thread. Gunze’s mission will continue to be centered on advancing the quality of life of patients by providing innovative solutions to improve clinical outcomes.
About MIMEDX
MIMEDX is a pioneer and leader in placental biologics, developing and distributing placental tissue allografts to help address unmet clinical needs in multiple sectors of healthcare, including the Advanced Wound Care market as well as in surgical recovery settings. MIMEDX is also focused on advancing a promising late-stage pipeline opportunity targeted at decreasing pain and improving function for patients with knee osteoarthritis. Our products are derived from human placental tissues and processed using our proprietary methods, including the Company’s own PURION® process. We employ Current Good Tissue Practices, Current Good Manufacturing Practices, and terminal sterilization to produce our allografts. MIMEDX has supplied over two million allografts, through both direct and consignment shipments. For additional information, https://www.mimedx.com
Contacts
Press
Gunze Limited Corporate Communication Department TEL: 81-6-6348-1314 (Shinji Nonaka)
Information posted here (product information, market launch date, contact, URL, etc.) is as of release date. Posted information is subject to change without notice.
