FOR IMMEDIATE RELEASE: 2022/02/25"RECELL® Autologous Cell Harvesting Device"
Gains Regulatory Approval 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, for manufacturing and marketing in Japan on February 17, 2022.
About Burns
Burns are classified into three categories according to the depth of injury: first-degree burns, superficial second-degreeburns, deep second-degree burns, and third-degree burns (Fig. 1). Extensive or deep burns can cause damage not only toskin tissue but also to major organs of the body, resulting in an extremely poor prognosis for the patient. For such patients, thenecrotic tissue is removed and replaced with a graft of healthy skin harvested from the patient in order to both shorten thetreatment duration and prevent infection (Fig. 2).
With the above treatment method, healthy donor skin the size of approximately 1/2 to 1/4 of the burn area is required tobe harvested. The patient must endure significant consequences such as pain during and after the procedure as well as therisk of extensive scarring (Fig. 3).

Fig.1) Depth of injury: Third-degree or extensive deep second-degree burns require skin grafting.

Harvest skin

Make slits

Expand into mesh

Graft to burnFig.2) Skin grafting: Several slits are made in the harvested skin and expanded for grafting.
A mesh patterned scar may be left after grafting.

1Fig.3) Donor site: Harvested area can be severely painful. Scarring and other disfiguring issues may occur.

About RECELL
RECELL is a device which 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 underhomogeneous physiological conditions. In addition, the suspension can be prepared in about 60 minutes in the operating room
utilizing RECELL, allowing for treatment to be initiated sooner upon physician discretion.
RECELL makes it possible to minimize the size of the required donor skin (Fig. 4, 5, 6), while providing the same
treatment outcome (epithelization) as standard skin grafting. It can also be applied to the donor site, which leads to better
results in accelerating wound healing.

1. Harvest healthy skin

2. Immerse in heatedenzyme solution3. Scrape with scalpel

6. Provides even supply ofvarious autologous skin cells

4. Cellular levelseparation of skin

5. Spray cell suspension
onto burn siteFig.4) Treatment process using RECELL

2During operation:
52 weeks post-operation:
Meshed graft: Donor site size is 1/2 of the burned area Meshed graft: Prominent meshed scarring
RECELL: Donor site size is 1/80 of the burned area
RECELL: No meshed scar despite equivalent cure rate

RECELL Alone

RECELL Alone

Meshed graft
Meshed graftFig. 5) 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)
12 weeks post-harvest:
Wounds heal faster and epithelialize with no scarring

Post skin harvesting for meshed graft:
Deeply invasive, painful, and high risk for scars

Fig. 6) RECELL treatment at the donor site (Courtesy of AVITA MEDICAL, the manufacturer)
In 2015 Taiwan's water park fire accident, provision of RECELL quickly saved the lives of many burn victims. We hopethat in the future in Japan as well, prompt treatment with RECELL will contribute as an option for physicians, not only in caseof accidents, but also in times of natural disasters or acts of terrorism.
Comment by Tatsuro Tsutsumi, CEO of COSMOTEC
We would like to express our sincere gratitude for the immense cooperation we have received from our fellow
collaborators such as medical professionals both domestic and overseas, along with government officials, for introducing thisproduct to Japan. We hope to contribute to the advancement of treatment technologies in the fields of emergency and plastic
surgery through this product. In addition, we will continue to strive to contribute to the realization of M3's group mission in the
spread of advanced medicine.
■COSMOTEC Overview
Established: December 1992 (a consolidated subsidiary of M3)
Location: Tokyo, Japan
Employees: Approx. 60 (including executives)
CEO: Tatsuro Tsutsumi

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