Approval obtained for a myocardial cell sheet in the United States and Europe, with expansion of sales regions

「In countries and regions outside the United States, we aim to sell the product in Indonesia, Australia, Singapore, the Middle East and Europe, among others, and are preparing cooperation with overseas hospitals and consultations with regulatory authorities.」

「For the product adapted for the U.S. market, we held a pre-IND meeting with the U.S. Food and Drug Administration (FDA). We discussed the overall development plan, including quality, preclinical and clinical aspects, and reached broad agreement with the FDA on future policy, including an outline of the First-in-Human trial. We are preparing for submission of an Investigational New Drug (IND) application in the United States.」

「In December 2024, we entered into a joint research and development agreement with the Division of Cardiothoracic Surgery at Stanford University. In the United States, we plan to develop a product adapted from the existing cardiomyocyte sheet for the U.S. market and products derived from iPS cells based on new concepts, and will conduct a joint research program consisting of animal experiments involving transplantation into the hearts of pigs with myocardial infarction. We have also begun discussions with external experts with the aim of holding an FDA consultation in the first half of the following fiscal year.」

「During the interim consolidated accounting period under review, we held discussions with local research institutions regarding joint research agreements and research and development plans for commercialization in the United States. In addition, we established iReheart Inc. as our U.S. subsidiary at the “Japan Innovation Campus,” a business base established by the Ministry of Economy, Trade and Industry in Palo Alto, California, to strengthen local activities including research and development and commercialization of our products and the search for future partners. We aim to hold an FDA consultation in the first half of the next fiscal year as we advance development in the United States.」

「At a meeting of the Board of Directors held on 26 June 2024, we resolved to establish a new subsidiary in the United States. It will be established to strengthen local activities, including research and development and commercialization of our products in the United States and the search for future partners.」

「For the human iPS cell-derived cardiomyocyte sheet, we have long been working to secure a U.S. base in order to obtain marketing approval not only in Japan but also overseas. During the cumulative third-quarter period under review, the Ministry of Economy, Trade and Industry opened a business base in Silicon Valley, United States, and invited companies to move in. We applied and were selected as a tenant.」

「For the human iPS cell-derived cardiomyocyte sheet, we plan to obtain marketing approval not only in Japan but also in the United States and other markets. We are currently preparing overseas research and development bases and systems, formulating development plans and selecting alliance partners.」

「For the above human iPS cell-derived cardiomyocyte sheet, we plan to expand the sales territories beyond Japan and obtain marketing approval in the United States and Europe. We are currently preparing overseas development bases and systems, formulating development plans and selecting alliance partners.」

「We plan to expand the sales territories for a human iPS cell-derived cardiomyocyte sheet for ischemic heart disease, the same indication as PJ1, beyond Japan and obtain marketing approval in the United States and Europe.」