FOR IMMEDIATE RELEASE: 2022/9/1"RECELL® Autologous Cell Harvesting Device" Insurance Coverage Begins in Japan~ Medical Device for Acute Burns and Donor Sites ~M3, Inc. (Headquarters: Tokyo, Japan; CEO: Itaru Tanimura; URL: https://corporate.m3.com/;“M3” below) has announced that its subsidiary COSMOTEC Co., Ltd. (Headquaters: Tokyo, Japan;
CEO: Tatsuro Tsusumi; “COSMOTEC” below) gained approval of "RECELL® Autologous Cell
Harvesting Device" (“RECELL” below), a medical device for acute burns and donor sites, formanufacturing and marketing in Japan on February 17, 2022, is now covered by insurance as oftoday.
RECELL is the first medical device that the M3 Group has marketed as its own product andhas carried out the entire process from seed development to insurance coverage. In the future, inaddition to its own products, the M3 Group will accelerate its efforts to expand its presence as apartner in the launch strategies of new technologies and products from domestic and foreign
medical device manufacturers and ventures in Japan.
【Summary of marketing approval and insurance coverage for RECELL 】
Brand name：RECELL Autologous cell harvesting and non-cultured cell suspension preparation kit
Generic name： Kits for autologous skin cell transplantation
Medical device approval number： 30400BZX00039000
Class classification： Highly controlled medical devices Class III
Insurance reimbursement category： C2 (New features and technologies)
Insurance reimbursement price： RECELL1920： 897,000 yen / RECELL640： 836,000 yen*For use, please review RECELL's notes on material price calculation.

Intended use/Method of use：
This product is a medical device intended to produce a non-cultured cell suspension from skinfragments taken from patients and to promote wound healing in acute burns and skin grafts. The
Central Social Insurance Medical Council has also published documents on this matter.
【About RECELL】
RECELL is a medical device used in burn cases, mainly for deep degree II and III burns. It
can separate harvested skin on a cellular level to produce an autologous cell suspension, requiring
donor skin of only 1/80 times the size of the burn area. By directly spraying this suspension onto
the burn site, it allows the cells necessary for skin formation, such as keratinocytes, pigment cells,and fibroblasts, to grow evenly under homogeneous physiological conditions.
RECELL makes it possible to minimize the size of the required donor skin, while providing thesame treatment outcome (epithelization) as standard skin grafting. It can also be applied to thedonor site, which leads to better results in accelerating wound healing. In addition, the suspension
can be prepared in about 30 to 60 minutes in the operating room utilizing RECELL, allowing fortreatment to be initiated sooner upon doctor discretion.
2. Immerse in heatedenzyme solution

1. Harvest healthy skin

3. Scrape with scalpel

6. Provides even supplyof various autologus skincells

4. Cellular levelseparation of skin

5. Spray cell suspension
onto burn site

Figure 1：Treatment process using RECELL.

During operation:

Meshed graft: Donor site size is 1/2 of the burned area
RECELL: Donor site size is 1/80 of the burned area

52 weeks post-operation:

Meshed graft: Prominent meshed scarring
RECELL: No meshed scar despite equivalent cure rate

RECELL 単独
RECELL 単独

RECELL Alone

RECELL Alone
網状植皮

網植皮
Meshed graft

Meshed graftFig. 2) Case from a U.S. clinical trial: RECELL alone vs. doubled meshed graft in the same patient.
(Photographs courtesy of Kevin Foster, MD, MBA, FACS, Arizona Burn Center, Phoenix, AZ, USA)Post skin harvesting for meshed graft:
Deeply invasive, painful, and high risk for scars

12 weeks post-harvest:
Wounds heal faster and epithelialize with no scarringFig. 3) RECELL treatment at the donor site (Courtesy of AVITA MEDICAL, the manufacturer)

Comment by Tatsuro Tsutsumi, CEO of COSMOTEC.
RECELL is the first medical device to be marketed as an in-house product by the M3 Group,
which handles the entire process from seed development to insurance coverage. The process ofbringing the product to market involves a wide range of steps, including the development of productseeds, the formation of partnerships using capital alliances, obtaining regulatory approval,
obtaining insurance reimbursement, e-promotion and the implementation of distribution processes.
The product has been launched as a result of the skills and know-how possessed by each company
across divisions and group companies within the M3 Group, and also as a result of the generous
support of doctors from related academic societies.
We will continue to contribute to saving the lives of as many patients with burns as possible andreturning them to their daily lives as soon as possible through this product. We will also combine
the Group's capabilities to support the launch strategies of new technologies and products in Japan,
not only our own products, but also those of domestic and foreign medical device manufacturers
and ventures.
Comment by Avita Medical CEO Dr. Mike Perry
We are very pleased that the Japanese Ministry of Health, Labour and Welfare has grantedmarketing approval under favourable conditions. We look forward to continuing to work with ourvalued partner, Cosmotec, in promoting RECELL in the Japanese market.
■COSMOTEC Overview
Established: December 1992
Location: Tokyo, Japan
CEO: Tatsuro Tsutsumi
Business Type：Type 1 medical device manufacturing and sales business (Cardiac Surgery,General Surgery, Sales of medical equipment mainly for endovascular treatment / Sales ofgeneral medical equipment and hospital equipment）