NEWS RELEASE
Towards the Creation of Novel Regenerative Medical Products in the Field of Ophthalmology

Marketing Approval Application for Autologous Cultured Oral Mucosal Epithelium(Development Name: COMET01)
September 14, 2020
Japan Tissue Engineering Co., Ltd.

The Fujifilm subsidiary Japan Tissue Engineering Co., Ltd. (J-TEC, head office: Gamagori City, Aichi Prefecture, President &CEO: Kenichiro HATA) has announced that it has made a marketing approval application to the Ministry of Health, Labour andWelfare for autologous cultured oral mucosal epithelium (development name: COMET01), a regenerative medical product for*1

the treatment of corneal epithelial stem cell deficiency .
J-TEC has introduced techniques for autologous cultivated oral mucosal
epithelial cell sheet transplantation developed by Professor Koji NISHIDA of Osaka
University Graduate School of Medicine (Department of Ophthalmology) andperformed a sponsor-initiated clinical trial of COMET01 since September 2016
following an investigator-initiated clinical trial performed by Professor Nishida’sgroup.
COMET01 is a cell sheet derived from autologous oral mucosal epithelium
prepared by cultivating cells collected and isolated from patients’ own oral mucosal
tissue. It is transplanted to enable the regeneration and proliferation of theAutologous cultured oral mucosal epithelium(Development name: COMET01)

patient's own oral mucosal epithelial cells and reconstruction of missing corneal
epithelium. COMET01 is anticipated as a new treatment for patients with extensive corneal opacity in both eyes and markedly
reduced visual function due to corneal epithelial stem cell deficiency.
COMET01 is to be marketed by the ophthalmological medical device manufacturer NIDEK Co., Ltd. (Gamagori City, AichiPrefecture, President and CEO: Motoki OZAWA).
As a pioneer in regenerative medicine in Japan, J-TEC obtained marketing approval for the first regenerative medical productin Japan, the autologous cultured epidermis “JACE,” in 2007 and began marketing in 2009. With the aim of promoting thespread of regenerative medicine, the autologous cultured cartilage “JACC” came on the market in 2013 and the autologous*2

cultured corneal epithelium “NEPIC ” was introduced in 2020. JACC and NEPIC were the first regenerative medical products inJapan in the fields of orthopedic surgery and ophthalmology, respectively.
By further consolidating sales of its existing products and accelerating the development of new regenerative medicalproducts, J-TEC will continue to promote the commercialization of regenerative medicine and contribute to improving qualityof life (QOL).
*1 A disease that occurs due to the disappearance of corneal epithelial stem cells present in the corneal limbus, the boundary region between the conjunctiva and the cornea, as aresult of congenital or external factors. Clinical symptoms such as corneal opacity, reduced visual acuity, and ophthalmalgia are observed.
*2 NEPIC is marketed by the ophthalmological medical device manufacturer NIDEK Co., Ltd.

Inquiries concerning this topic:
Japan Tissue Engineering Co., Ltd.
Corporate Planning Department, Corporate Management HQ
TEL: 0533-66-2020

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