July 30, 2012
PRESS RELEASE
Company Name: Japan Tissue Engineering Co., Ltd. (J-TEC)
Representative: Yosuke Ozawa, President and CEO(Stock Code: 7774 JQ)
Headquarters:
6-209-1 Miyakitadori, Gamagori, Aichi, Japan
Contact:
Masahito Obayashi
Director, Corporate Management & Administration Dept.
URL:
http://www.jpte.co.jp/english/index.html

J-TEC Received Government Approval to Manufacture and Sell
Autologous Cultured Cartilage JACC® in JapanOn July 27, 2012, Japan Tissue Engineering Co., Ltd. (also known as J-TEC), which is headquartered inGamagori, Aichi, Japan and represented by Yosuke Ozawa, received an approval by Japan's Ministry of Health,Labour and Welfare (MHLW) for manufacturing and sales of autologous cultured cartilage JACC® in Japan.
JACC® is a tissue-engineered medical product with the aim of improving people’s quality of life.
OUTLINE OF APPROVAL
Approval Number

22400BZX00266000

Approval Date

July 27, 2012

Generic Name

Human Autologous Tissue for Transplantation

Product Name

JACC®

Structure, Principle

This product is autologous cultured cartilage created by sampling the patient’sown cartilage tissue, culturing separated cartilage cells in atelocollagen, for use
by the same patient.

Purpose, Indications

Relief of symptoms of traumatic cartilage defects and osteochondritis dissecans(exclude osteoarthritis) for knee joints. The use of this product is limited topatients with a defect area of over 4cm2 with no alternative therapy.

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 theneed for radical therapy. Under the conviction that autologous cultured cartilage will make great contribution to
the quality of life of these patients, J-TEC has introduced related techniques from Professor Mitsuo Ochi, MD.
(Professor of Orthopaedic Surgery in the Hiroshima University Graduate School of Biomedical Sciences), thepioneer in this field who has demonstrated the efficacy of autologous cultured cartilage through intensive
clinical research, and committed to the commercialization of such medical product.
Professor Ochi started therapy for knee-joint cartilage defects using tissue-engineering technique in Japan since
1996, and has experience of over 100 cases of clinical treatment. His research results are highly evaluatedamong academies all over the world. Since 2003 he has advised J-TEC on the development of autologous
cultured cartilage in his capacity as a consultant.

ABOUT JACC®
A small amount of cartilage cells is obtained from an unloaded part of the patient's own knee joint. The cells arethen cultivated in atelocollagen, a gel-like material, before being implanted into the defect. This method ischaracteristic 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 useof patient's own cells significantly reduces the risk of immunologic rejection.
Some part of the development of this product was approved by Japan Science and Technology Agency (alsoknown as JST) as one of its contract development projects. The result was accredited as successful in February
2008.
INFLUENCE ON FINANCIAL STATUS
This matter has been progressing as planned, and 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 2013.

PHOTOGRAPH OF CULTURED CARTILAGE

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