August 24, 2009
PRESS RELEASE
Company Name: Japan Tissue Engineering Co., Ltd. (J-TEC)
Representative: Yosuke Ozawa, President and CEO(Stock Code: 7774 NEO)
Headquarters:
6-209-1 Miyakitadori, Gamagori, Aichi, Japan
Contact:
Masahito Obayashi
Director, Corporate Management & Administration Dept.
URL:
http://www.jpte.co.jp/english/

ANNOUNCEMENT: J-TEC HAS SUBMITTED AN APPLICATION FOR
MANUFACTURING AND SALES OF AUTOLOGOUS CULTURED CARTILAGE
Japan Tissue Engineering Co., Ltd. (also known as J-TEC), which is headquartered in Gamagori, Aichi, Japan andrepresented by Yosuke Ozawa, has submitted to Japan's Ministry of Health, Labour and Welfare (MHLW) anapplication for manufacturing and sales of autologous cultured cartilage on August 24, 2009. Autologous cultured
cartilage is a tissue-engineered medical product with the aim of complementing or repairing of damaged knee
cartilage as well as improving the knee function.
BACKGROUND
Due to its lack of blood vessels, cartilage tissue does not cure well once it is damaged in an accident or injury.
Drugs and surgery to relieve symptoms has thus been the standard of care. On the other hand, different kinds ofjoint problems have been on the rise due to various sports injuries and aging of the society, emphasizing the needfor radical therapy. Under the conviction that autologous cultured cartilage will make great contribution to thequality of life of these patients, J-TEC has committed to the commercialization of such medical product.
We have introduced related techniques from Professor Mitsuo Ochi, MD, Director of Hiroshima University
Hospital, who has demonstrated the efficacy of autologous cultured cartilage through intensive clinical research.
AUTOLOGOUS CULTURED CARTILAGE
With autologous cultured cartilage, a cartilage defect is repaired as follows: A small amount of cartilage cells isobtained from an unloaded part of the patient's own knee joint. The cells are then cultivated in atelocollagen, agel-like material, before being implanted into the defect. This method is characteristic in two aspects: The
three-dimensional cultivation in a gel produces a cartilage tissue with a stable shape, which, unlike fluidal material,
does not leak after being implanted. The other characteristic is that the use of patient's own cells significantly
reduces the risk of immunologic rejection.
Some part of the development of this product was accepted by Japan Science and Technology Agency (also knownas JST) as one of its contract development projects. The result was accredited as successful in February 2008.
MILESTONES IN THE APPROVAL PROCESS
September 2001

Clinical trial application submitted to MHLW

February 2004

Clinical trial application approved by MHLW

April 2004

Clinical trial protocol submitted to MHLWMarch 2007

Clinical trial completion notification submitted to MHLWINFLUENCE ON FINANCIAL STATUS
This matter does not have influence on projections for J-TEC's financial figures of the second quarter and full-year of
the fiscal year that ends in March 2010.
Timing of approval for manufacturing and sales of autologous cultured cartilage is unknown due to its fulldependence on the regulatory review process.
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PHOTOGRAPH OF CULTURED CARTILAGE

FLOWCHART OF CULTURED CARTILAGE TRANSPLANTATIONFOR MORE INFORMATION ON THE CONTENTS OF THIS PRESS RELEASE:
Norio Sakakibara
PIR Manager, General Administration
Corporate Management & Administration Dept.
Japan Tissue Engineering Co., Ltd.
E-mail: jtec-info@jpte.co.jp