Sept. 15, 2021
Japan Tissue Engineering Co., Ltd.

Announcing approval of Autologous Cultured Oral Mucosal Epithelium “Ocural”
for NHI listing
Listing effective December 1 creates new option for treatment of bilateral limbal stem cell deficiency

Japan Tissue Engineering Co., Ltd. (J-TEC, headquarters in Gamagori, Aichi Prefecture;
President & CEO Ken-ichiro Hata) announces the approval of Autologous Cultured Oral Mucosal
Epithelium “Ocural” for inclusion in the National Health Insurance price list effective December 1,
2021, at the general meeting of Central Social Insurance Medical Council (Chuikyo) held today.
Ocural” is expected to be of benefit as a new treatment
method for patients who have had marked declines in visualacuity owing to extensive corneal damage from limbal stem
cell deficiency. *1
With the corporate vision of “creating a future forregenerative medicine”, J-TEC is building a regenerative
medicine industry while contributing to the improvement ofpatients’ quality of life (QOL) by continually developing andlaunching new regenerative medical products in addition topromoting the spread of its existing products.
[Insurance reimbursement price (dated December 1, 2021)]

Autologous Cultured Oral Mucosal
Epithelium “Ocural”① Tissue transport kit *2
4,280,000 yen*35,470,000 yen②Cultured oral mucosal epithelium package[Product Features]
1. This is the world’s first regenerative medical product that uses oral mucosal epithelial cells to treat
limbal stem cell deficiency.
2. It is a domestic product that represents the commercial application of technology introduced byOsaka University.
3. “Ocural” expands treatment options for corneal epithelial disorders, for which no radical treatment
method has existed heretofore. It will make it possible to treat patients for whom our previously
approved product Autologous Cultured Corneal Epithelium “Nepic*4” is not indicated.
[Background/history of development]
In the development of this product, an investigator-initiated clinical trial was conducted by aresearch team led by Professor Kohji Nishida and Lecturer Yoshinori Oie of the Department ofNeural and Sensory Organ Surgery (Ophthalmology) , Graduate School of Medicine, Osaka
University, with the support of AMED.*5 Together with introducing the autologous cultured oral
mucosal epithelial cell sheet transplantation technology that Professor Kohji Nishida was the first in
the world to develop, J-TEC took over the investigator-initiated clinical trial in the new form of acorporate clinical trial of “Ocural” in September 2016. In September 2020, J-TEC submitted amarketing approval application to the Ministry of Health, Labour and Welfare for “Ocural” as its
second regenerative medical product in the ophthalmology area, and in June 2021 marketing
approval was obtained. “Ocural” was designated a regenerative medical product for orphan
diseases, *6 specifically, the treatment of limbal stem cell deficiency, in 2020.
“Ocural” will be marketed by ophthalmological medical device maker Nidek Co., Ltd. (Gamagori,Aichi; President and CEO Motoki Ozawa)
Japan Tissue Engineering Co., Ltd., 6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan. URL: https://www.jpte.co.jp

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[Summary of NHI listing]
Brand name
OcuralDate of NHI listing

December 1, 2021

Insurance reimbursement ① Tissue transport kit*2 4,280,000 yen
price② Cultured oral mucosal epithelium package*3 5,470,000 yen
Classification category

C2 (new function/new technology)

Main purposes of use

This product is “Autologous Cultured Oral Mucosal Epithelium” inwhich the patient’s own oral mucosal tissue is harvested and theisolated oral mucosal epithelial cells are cultured and formed into asheet for use by the patient himself. This product is indicated for limbal
stem cell deficiency, and it is applied to the ocular surface that
includes the corneal limbal region to repair the corneal epithelium.

Points to note (Draft)

150 Human autologous tissue(6) Autologous cultured oral mucosal epithelium
I. Fee can be calculated for one-time use in one eye only, in cases oflimbal stem cell deficiency with severity of severe Stage IIA disease(limited to cases where reconstruction of corneal epithelium is notachieved even with removal of conjunctival scar tissue (whennecessary, amniotic membrane graft)), Stage IIB, or Stage III.
II. The fee for the autologous cultured oral mucosal epithelium
preparation and transplantation kit can be calculated only in cases ofuse by a physician to whom one of the following applies.
a Full-time physician with no less than 5 years of experience inophthalmology and no less than 5 years of experience performing
corneal transplants.
b Has completed the necessary training, which consists of thefollowing.
i Items related to the indications of autologous cultured oral
mucosal epithelium
ii Items related to determination of the severity of limbal stem cell
deficiency
iii Items related to method of harvesting oral mucosal tissue
iv Items related to method of transplantation
III. The fee for the autologous cultured oral mucosal epithelium
harvesting and culturing kit can be calculated only in cases of use bya physician who has completed the training on the method ofharvesting oral mucosal tissue.
IV. A detailed description of symptoms, including the severity of limbal
stem cell deficiency, must be attached to the invoice when billing for
medical service fees for patients using human autologous tissue(autologous cultured oral mucosal epithelium).

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

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Transplantation of autologous cultured oral mucosal epithelium “Ocural”
Patient
Harvesting of oral mucosal tissue
Isolation of oral mucosal epithelial cells

Feeder cells: cells used to create thenecessary environment for proliferation oforal mucosal epithelial cells

Seeding of oral mucosal epithelial cells

Feeder cells

Transplantation

Sheet formation

Culturing[Earnings Estimate]
J-TEC announced its business plan for this product in the Mid-Term Management Plan (Items
related to Business Plans and Growth Potential) dated May 11, 2021, and because the project isproceeding according to plan, it will have no effect on the earnings forecast for the full year ending inMarch 2022. We will promptly notify you of any new facts that will have a major impact on J-TEC’s
business results.
*1*2*3*4*5*6

A disease in which corneal epithelial stem cells, which exist in the corneal limbus at the border between the cornea and theconjunctiva, are lost owing to congenital or exogenous factors. LSCD presents with clinical symptoms such as clouding of the cornea,
decline in visual acuity, and eye pain.
Kit consisting of the materials used from the time the oral mucosal epithelial tissue is harvested from the patient to the time that cell
culturing ends.
Kit consisting of the materials used after cell culturing ends, through the preparation of the oral mucosal epithelial sheet and up until
the end of the transplantation procedure.
NEPIC is made by culturing corneal epithelial stem cells harvested from the patient’s own corneal limbic tissue into the form of sheetsthat are transplanted back into the patient’s eyes to reconstruct the corneal epithelium. NEPIC was included in the National Health
Insurance price list in June of 2020, and it is marketed by Nidec Co., Ltd.
Japan Agency for Medical Research and Development
Regenerative medical products for the treatment of orphan diseases that are designated by the Minister of Health, Labour andWelfare in accordance with the Pharmaceuticals and Medical Devices Law. Products with this designation receive preferentialtreatment, such as grants for research, priority clinical trial consultation and review, and extension of the reexamination period. Inorder for a product to be designated a regenerative medical product for orphan diseases, it must have a target disease that affects
fewer than 50,000 patients in Japan and lacks a suitable alternative treatment method, and the product must have exceptional
medical utility value, such as efficacy and safety that can be expected to greatly surpass those of existing treatment methods.

(Reference: About J-TEC)
J-TEC is a maker of regenerative medical products whose corporate vision is “creating a future forregenerative medicine”. As Japan’s top runner in regenerative medicine, J-TEC obtained marketing
approval for autologous cultured epidermis “JACE”, Japan’s first regenerative medical product, inOctober of 2007, and began marketing the product in January of 2009. J-TEC then went on to obtainmarketing approval for Autologous Cultured Cartilage “JACC” in July of 2021, for AutologousCultured Corneal Epithelium “Nepic” in March of 2020, and for Autologous Cultured Oral Mucosal
Epithelium “Ocural” in June 2021. “JACC” was Japan’s first regenerative medical product for use inorthopedic surgery, and “Nepic” was the first for use in ophthalmology. Of the 13 regenerative
medical products that have been approved in Japan, four are J-TEC products.
END OF DOCUMENT[Contact information for inquiries about this announcement]
Japan Tissue Engineering Co., Ltd.
Business Planning Department
TEL0533-66-2020
E-mail jtec-info@jpte.co.jp
Japan Tissue Engineering Co., Ltd., 6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan. URL: https://www.jpte.co.jp

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