September 17, 2024
Japan Tissue Engineering Co., Ltd.

Announcement on the Progress of the Clinical Trial of
Allogeneic Cultured Epidermis Allo-JaCE03
Japan Tissue Engineering Co., Ltd. (Headquarters: Gamagori, Aichi Prefecture; President andCEO: Ken-ichiro Hata) is developing Japan’s first dried allogeneic cultured epidermis made fromthe skin tissue of another person (development name: Allo-JaCE03, medical device). We haverecently notified the Pharmaceuticals and Medical Devices Agency (PMDA) of the completionof our clinical trial targeted at deep dermal burn*1 (hereinafter referred to as "the Trial"). The
progress of the Trial is as follows.
1. Overview of the Trial
The Trial was targeted at patients with deep dermal burn and intended to verify the efficacy
and safety of Allo-JaCE03. The Trial ended with the treatment and follow-up of all cases
completed. We have fixed the data obtained through the Trial concerning the cases andconducted a data analysis with regard to efficacy and safety. The results are outlined below.
2. Key analysis resultsl The primary endpoint was the epithelialization rate*2 at the Allo-JaCE03 application siteon the 7th day after initial application. This parameter demonstrated a statisticallysignificant improvement compared to the one estimated with existing treatments(p=0.0123, Student’s t-test).
l No adverse events of concern were observed.
The Trial showed that, in patients with deep dermal burn, epithelialization was recognized as
early as on the 7th day after initial application. No adverse events of concern were observed
during about the 3-month period after initial application, which is immensely significant.
*1: Skin burns are classified into three categories by depth: epidermal burn, deep dermal burn, and deep burn. A deep
dermal burn, which injures skin deep down to the dermis, takes time to heal and may inflict permanent damage attimes. Depending on circumstances, even surgery may be necessary.
*2: The epithelialization rate means the percentage of the epithelialized area where defected skin is re-covered byepidermis.

[Comment from President Ken-ichiro Hata]
This is an Off-The-Shelf product which can be manufactured and stored in advance, and I
think it provides a simpler means of treatment of mild degrees of burn injury. Building on thestable cell culture techniques that we have developed over the years has made us ready formass production. Since this product does not contain living cells, its treatment effect is different
from that of the autologous cultured epidermis JACE. So, I think it represents a new step inmedicine that the clinical trial has demonstrated the efficacy of the product. We are going to put
together the data and submit a marketing approval application as quickly as possible. We will
stay committed to the development of regenerative medicine by making full use of thetechnologies we possess.

Japan Tissue Engineering Co., Ltd., 6-209-1 Miyakitadori, Gamagori, Aichi 443-0022 Japan. https://www.jpte.co.jp/en1/2

About allogeneic cultured epidermis
J-TEC is developing Japan’s first allogeneic cultured epidermis madefrom the skin tissue of another person (development name: AlloJaCE03). A clinical trial targeted at deep dermal burn has been
underway since November 2021, and the treatment and follow-up of
all cases have been completed recently.
[Features of the product]
1. Since the raw material is allogeneic cells, systematic massproduction of a product that meets certain quality requirements ispossible.
2. Once dried, the cultured product can be stored at room temperature
for long periods of time. Medical institutions can keep it in stock sothat it can be used without delay whenever needed.
3. Taking advantage of the features of Off-The-Shelf product, J-TEC
is going to accelerate the marketing of this product not only in Japanbut also in overseas markets.

Before being moistened with water

After being moistened with water[Contact information for inquiries about this announcement]
Japan Tissue Engineering Co., Ltd.
E-mail. jtec-info@jpte.co.jp

Japan Tissue Engineering Co., Ltd., 6-209-1 Miyakitadori, Gamagori, Aichi 443-0022 Japan. https://www.jpte.co.jp/en2/2