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HOME >> Investor Relations >> Top Message >> Message Archive (January 5, 2015)

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To Our Investors - January 5, 2015 -

Happy New Year! The year 2015 will be an eventful year for Japan Tissue Engineering (J-TEC). We ask for your continued support this year.

Changes in the external environment

Yosuke Ozawa

The Ministry of Health, Labour and Welfare, Ministry of Economy, Trade and Industry and Ministry of Education, Culture, Sports, Science and Technology cooperated to enact two laws on November 25, 2014: the Pharmaceutical and Medical Device Act and the Act on the Safety of Regenerative Medicine. In addition, multiple industry groups are actively carrying out activities to ensure that an appropriate assessment of innovations, including regenerative medicine products, will be reflected in the Japanese insurance system.

In 2015, J-TEC will properly take advantage of these changes in the business environment. We will engage in the clinical trials and approval review of our next-generation products, with an eye to the early approval system of products including regenerative medicine products that was newly defined in the Pharmaceutical and Medical Device Act. We will also make efforts in our consulting services to medical institutions and commissioning of cell culturing, under the Act on the Safety of Regenerative Medicine, to assist the provision of a practitioners-led regenerative medicine.

Overseas regulatory authorities and companies are also keeping a keen eye on the changes in the environment surrounding regenerative medicine in Japan. Although we expect that there will be entrants into the Japanese market from overseas, at J-TEC we will first strive to establish success cases.

Fourth floor construction of the headquarters building

The construction of the fourth floor of J-TEC’s headquarters building is well underway. On the fourth floor, we will introduce a new manufacturing facility in preparation for the increased production of our Autologous Culture Cartilage "JACC". Although we are having a slow start in launching the JACC business, which is now in its second year after going on the market, orders are steadily increasing. In the 2014 fiscal year, we plan on receiving orders for around 100 cases, but we will make efforts to increase this number by tenfold within the next few years.

The manufacturing of products including regenerative medicine products requires a clean room similar to a semiconductor manufacturing plant. Conducting the construction of our fourth floor while simultaneously running our third-floor manufacturing facility is a very challenging task. We are probably the first to attempt this rare type of construction in Japan. We will aim for the completion of the construction in spring 2015, while fostering close cooperation between our employees and the partner company working on the construction.

Going forward as a member of the Fujifilm Group

As of December 26, 2014, J-TEC became a consolidated subsidiary of Fujifilm Holdings Corporation. At the end of the year, we had a meeting with Fujifilm Chairman, Mr. Shigetaka Komori, during which we expressed our gratitude and also received advice on J-TEC’s management in the future.

Although the promotion of the practical application of regenerative medicine is positioned as one of Japan’s growth strategies, the regenerative medicine industry is still in its early days. Through our exchange of opinions with Chairman Komori, I recognized that J-TEC needs to tackle changes more dynamically.

At J-TEC, we will accelerate our businesses while exerting further synergy with Fujifilm. Furthermore, we will strive toward the industrialization of regenerative medicine, which is a common goal of Fujifilm and J-TEC.

 

January 5, 2015
Yosuke Ozawa
President & CEO
Japan Tissue Engineering Co., Ltd.