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HOME >> Investor Relations >> Top Message >> Message Archive (October 30, 2009)

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To all of our investors - October 30, 2009 -

Yosuke Ozawa, President and CEO Japan within the worod, J-TEC within Japan

Looking back over the first half of this fiscal year for the Japan Tissue Engineering Co., Ltd. (J-TEC), we have two major achievements. One: a striking increase in orders for the autologous cultured epidermis JACE; Two: submission of the application for the sale and manufacture of the autologous cultured cartilage.

Due to the limits imposed on health insurance coverage for treatment using JACE, the amount of orders does not necessarily correspond with our sales. However, as the premier launch of regenerative medicine in Japan, we believe that we have gotten off to a successful start. In the last six months, we have provided JACE to dozens of severe burn patients ranging from an infant to a patient over 80 years old. Despite the fact that shipments provided without charge for humanitarian reasons actually outnumbered the sales we were able to register, without a doubt, we were able to reaffirm the presence of a growing regenerative medicine market in Japan. Regardless of the insurance coverage for JACE, it is the favorable recovery of patients that encourages J-TEC members, and it is the duty of the management to develop the JACE business into a profitable operation for J-TEC.

On August 24, we submitted an application for the sale and manufacture of the autologous cultured cartilage, which we had originally promised to you, our stockholders, to submit by the end of the last fiscal year, but regrettably we had to ask for a six-month extension. The inquiries and confirmations between the government agency PMDA (Pharmaceuticals and Medical Devices Agency) and J-TEC are now in progress. Eight years have already passed since J-TEC submitted an application to start clinical trials on cartilage. In other countries of the world, TiGenix of Belgium has obtained approval from the European Medicines Agency (EMEA) for their cartilage product, as the first Advanced Therapy Medicinal Product in Europe. We, at J-TEC, hope to follow in their successful footsteps and further develop our business here in Japan.

The pictures shown at the top were taken when I gave a special presentation, as a result of a wonderful opportunity given to me at the 18th Research Council Meeting of the Japan Society of Plastic and Reconstructive Surgery (Oct. 1-2). The excitement at the Meeting made me realize that regenerative medicine therapy has come under the spotlight in clinical practice, and JACE is definitely starting to penetrate. The “Regenerative Medicine Industry in Japan” was the title of my presentation. In this presentation, I asked: can regenerative medicine in Japan bridge the gap with the foreign countries that have preceded us in its development? What is the role of J-TEC? It is my strong hope that, a variety of tissue-engineered medical products will be commercialized in a competitive environment in Japan, providing widely expanded clinical treatment options for patients.

October 30, 2009
Yosuke Ozawa
President & CEO
Japan Tissue Engineering Co., Ltd.