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HOME >> Investor Relations >> Top Message >> Message Archive (April 1, 2012)

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To Our Investors - April 1, 2012 -

The new fiscal year has begun. Fiscal 2012 will be an important year for Japan Tissue Engineering Co., Ltd. (J-TEC) in regard to our effort to promote the industrialization of regenerative medicine.

A Second Piece of Good News

Yosuke Ozawa The first piece of good news came in April 2010, when the insurance reimbursement standards for the autologous cultured epidermis, JACE, were revised, and the institutional standards were reviewed as well. Now there is a second piece of good news: Based on the April 2012 revision of medical fees, the number of JACE sheets covered by insurance has increased. Until now, insurance covered a maximum of 20 sheets, but now up to 40 sheets will be covered. The welcome news for our company is that we will be able to sell JACE at the same insurance-reimbursed price of 306,000 yen per sheet.

I am pleased that an environment has been created in which people who have unfortunately suffered burn injuries can have access to the quantities of JACE necessary for effective treatment. Until now, from a humanitarian standpoint, J-TEC has filled orders for 21 or more sheets at no charge. However, now that the quantity covered by insurance has increased, our profit-and-loss situation will certainly improve. In the past, the Board of Directors vigorously discussed the significance of our JACE business, including the pros and cons of providing JACE at no charge. I am glad that we did not give up on our JACE business along the way. Little by little, the industrialization of regenerative medicine is moving ahead. Perseverance makes one stronger.

The Goal for Autologous Cultured Cartilage

It has been 12 years since J-TEC embarked on the development of autologous cultured cartilage, and it has been two-and-a-half years since we applied to the Ministry of Health, Labor and Welfare for approval to manufacture and sell the product. We have set the approval of autologous cultured cartilage--something hoped for by medical practitioners, patients and shareholders alike--as our most important goal for fiscal 2012.

Because J-TEC has been listed on the JASDAQ market of the Osaka Securities Exchange, we publicly disclosed our three-year medium-term plan as well as our goal of obtaining approval for autologous cultured cartilage. Initially, we intended to obtain approval within two years of our application to the Ministry of Health, Labor and Welfare (August 2009). It took three years to obtain approval for JACE, and therefore, planning to utilize that experience, we set the goal of obtaining approval for cartilage in two years. The review by the Pharmaceuticals and Medical Devices Agency is ongoing, and we hope to attain approval by September, in the second half of fiscal 2012. Once we obtain approval, the insurance talks await us. We are managing the company so as to smoothly market autologous cultured cartilage as Japan’s second regenerative medicine product.

April 1, 2012
Yosuke Ozawa
President & CEO
Japan Tissue Engineering Co., Ltd.