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As introduced in the Top Message dated July 1, our company completed the post-marketing surveillance of Autologous Cultured Cartilage “JACC” in June. This means that the Ministry of Health, Labour and Welfare has certified that the product’s effectiveness status remains unchanged (no change necessary) in the light of the post-marketing surveillance that has been conducted in the approximately 7 years since we received marketing approval, and the analysis of the data. Of course, the safety and effectiveness of the product did undergo evaluation in the clinical trials conducted prior to approval. However, we are very pleased and truly grateful that our product has been used by many more doctors since its product launch and has still been shown to be effective. Even among regenerative medical products, those that are administered through injection or infusion of cells can be handled like ordinary medicines. However, that is not the case with the kinds of frontier products that we are supplying – those in which the patients themselves provide tissue for transplantation. The cooperation of the doctors who are in charge of the transplant is very important after marketing approval has been obtained for a product. Beginning with the selection of appropriate patients and on through the establishment and spread of stable operating procedures and optimization of post-operative management, etc., none of it could have been accomplished without the assistance of the doctors at all of the medical institutions. It truly makes us happy that it was possible to treat patients for lost tissue functions with their own cells. We believe that this not only is the ultimate tailor-made medicine, but also the kind of medical treatment that the patients themselves want. We have been able to open the door of regenerative medicine and take another step forward. We would like to take the many experiences we have accumulated since the market launch and utilize them broadly and effectively in the regenerative medicine business in the future.

In closing, we would like once again to thank the principals who contributed to these surveillance results. Of course, by this we mean the patients who received this treatment and diligently underwent the post-operative management and rehabilitation. To further meet the demands of everyone concerned, our company would like to go on making efforts to “create a future for regenerative medicine”.

July 20, 2022