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HOME >> Investor Relations >> Top Message >> Message Archive (April 1, 2010)

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To all of our investors - April 1, 2010 -

Yosuke Ozawa, President and CEO Good News

We have entered a new fiscal year. I am pleased to note that this new fiscal year will also bring many opportunities, so to all of the shareholders who have supported Japan Tissue Engineering (J-TEC) and our many stakeholders, please continue to hold high expectations for J-TEC.

13 New Employees

Based on medical treatment fee modifications effective from April 1st, insurance reimbursement standards for the autologous cultured epidermis “JACE” have been revised. JACE is a regenerative medical product developed for the purpose of treating serious burn injury patients. Although this product has been sold as a product eligible for insurance coverage since January 2009, up until now the insurance reimbursement was subject to certain institutional standards, with the result that only 25 medical institutions within Japan were actually able to receive insurance reimbursement. For institutions wishing to order JACE who did not meet these standards, it was felt that from an ethical standpoint, J-TEC should provide such institutions with JACE on a non-commercial basis, and this is what we have done. However, with this new modified medical treatment fee plan, it is projected that institutions which will be able to meet the newly established standards and therefore be eligible for insurance reimbursement, will now number more than 100. As a result, the major emergency medical care facilities and burn injury centers in Japan will be able to use JACE as a medical treatment which is covered by insurance. With the inclusion of these newly added institutions, it is projected that J-TEC’s sales will increase significantly.
Knowing that Japan’s medical insurance resources are limited, we appreciate this decisive action and consideration given to our product by the Health, Labor and Welfare Ministry. At the same time, we also extend our heartfelt gratitude to the Japanese Society for Burn Injuries, who negotiated with the Health, Labor and Welfare Ministry, as well as individuals affiliated with the Society, everyone at the Burn Patient Foundation, and our shareholders, who worked with us to form public opinion about this important issue.

Progress with Autologous Cultured Cartilage

Thirteen new employees, some who are new graduates and some who come with previous experience, have joined our company from April 1st. Although they come from various backgrounds, they have all come together to support the goal of the commercialization of regenerative medicine. Employees have been assigned to sales and manufacturing divisions, as we look to put the JACE project on track in earnest. Although it is called a bio-venture company, J-TEC is a manufacturer and seller of regenerative medical products. We now have more than 130 employees, aiming to be as professional as we can be, in our efforts to deliver high quality and safe products.

One important focus of the new fiscal year at J-TEC is the progress in the area of autologous cultured cartilage. It has been about 7 months since we filed for approval of the manufacture and sale of autologous cultured cartilage. The Pharmaceuticals and Medical Devices Agency is continuing with its review of our application. Although I am not able to disclose the details of the review to our shareholders and investors, I would like to take advantage of such vehicles as the NEO Milestone Disclosure to inform you as much as I can of the progress in this endeavor. Although J-TEC is a small scale operation, we already have some production equipment for the autologous culturing of cartilage. However, in order to be able to respond to the many orders expected after approval is obtained, this year we will carry out construction to expand our autologous cultured cartilage production facilities. In addition, we will accelerate the establishment and execution of our sales strategy. We are working hard to swiftly bring this new medical option to patients with knee joint problems.

April 1, 2010
Yosuke Ozawa
President & CEO
Japan Tissue Engineering Co., Ltd.

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