Obtained manufacturing and marketing approval for human iPS cell-derived cardiac muscle cell sheets and their commercialization
First written in FY2023. 15 of 24 entries say "Advanced", first in FY2024-Q1. Latest entry: 2026-09-29.
1 other company's latest entry also says "Advanced".
- 2026-09-05Advancedfinance.yahoo.co.jp
「Insurance coverage for the cardiac muscle sheet product “ReHeart” was announced on 1 September.」
Following approval, ReHeart had reached the stage at which insurance coverage was announced, but the article does not confirm that sales had begun. - FY2026AdvancedAnnual report
「In March 2026, we obtained conditional and time-limited marketing approval from the Ministry of Health, Labour and Welfare, with the indication “treatment of severe heart failure caused by ischemic cardiomyopathy inadequately responsive to standard treatments, including drug therapy and invasive treatment.” Going forward, we will prepare the supply system and other arrangements for post-marketing surveillance so that Reheart can be provided to patients as soon as possible.」
Reheart obtained conditional and time-limited marketing approval in Japan. Approval was achieved, but preparations for the supply system required for shipment and commercial launch after reimbursement listing remain. - FY2026-H1AdvancedAnnual report
「During the interim consolidated accounting period under review, we submitted an application for marketing approval to the Ministry of Health, Labour and Welfare in April 2025. Following submission, we have been responding to regulatory review and other procedures. In addition, we applied to have the human iPS cell-derived cardiomyocyte sheet designated as a regenerative medical product for rare diseases, and in October 2025 the Ministry of Health, Labour and Welfare designated it as such (Designation No. (R7再) No. 37).」
The company proceeded to respond to the regulatory review following submission of the manufacturing and marketing approval application and obtained orphan regenerative medical product designation in October 2025. Approval and commercialization had not yet been completed. - FY2025AdvancedAnnual report
「Following the completion of transplantation in the 8 subjects in Cohorts A and B, we conducted efficacy assessments through Week 26 and safety assessments through Week 52, compiled the results, and submitted an application for marketing approval to the Ministry of Health, Labour and Welfare in April 2025.」
The company compiled the 12-month follow-up results for 8 subjects and submitted the marketing-approval application. Approval and commercial launch remained pending regulatory review. - FY2025-H1AdvancedAnnual report
「During the interim consolidated accounting period under review, our directors and employees worked together on the marketing-approval application. In preparing the application materials, we incorporated long-term data into the materials in order to improve the prospects of obtaining an appropriate assessment and approval, taking into account the condition of patients with severe heart failure targeted by the investigator-initiated clinical trial. Going forward, we will consult repeatedly with PMDA and submit the application at an appropriate time.」
The company proceeded with incorporating long-term data into the application materials and moved toward submission following consultations with PMDA. Approval had not yet been obtained. - FY2024RestatedAnnual report
「For the 8 subjects in total, comprising 3 subjects in the first part of the trial (Cohort A) and 5 subjects in the latter part (Cohort B), we compiled the results of 12 months of follow-up after transplantation of the product under development. In April 2025, we submitted an application for marketing approval to the Ministry of Health, Labour and Welfare.」
The 12-month follow-up results for 8 subjects were compiled and the marketing-approval application was submitted. Obtaining approval and commencing commercial sales remained objectives following regulatory review. - FY2024-Q3RestatedAnnual report
「We continue to support the investigator-initiated clinical trial conducted by Osaka University toward obtaining marketing approval for a human iPS cell-derived cardiomyocyte sheet indicated for severe heart failure caused by ischemic heart disease (ICM). Transplantation in the planned 8 subjects was completed in March 2023. During the cumulative third-quarter period under review, 26-week efficacy assessments and safety assessments through Week 52 were conducted. We have also designated the early submission of the marketing-approval application as our top priority, concentrated management resources on it, and are handling the application process.」
Efficacy and safety assessments and preparation of the marketing-approval application continued after transplantation in 8 subjects. The company indicated that it would concentrate resources on early submission, but did not state that an application had been filed. - FY2024-Q2RestatedAnnual report
「We continue to support the investigator-initiated clinical trial conducted by Osaka University toward obtaining marketing approval for a human iPS cell-derived cardiomyocyte sheet indicated for severe heart failure caused by ischemic heart disease (ICM). Transplantation in the planned 8 subjects was completed in March 2023. During the cumulative second-quarter period under review, 26-week efficacy assessments and safety assessments through Week 52 were conducted. We also continued preparing the application documents and related materials for marketing approval.」
Efficacy and safety assessments following transplantation in 8 subjects and preparation of the application documents continued, with no material change in the objective from the previous quarter. - FY2024-Q1AdvancedAnnual report
「We continue to support the investigator-initiated clinical trial conducted by Osaka University toward obtaining marketing approval for a human iPS cell-derived cardiomyocyte sheet indicated for severe heart failure caused by ischemic heart disease (ICM). Transplantation in the planned 8 subjects was completed in March 2023. During the cumulative first-quarter period under review, 26-week efficacy assessments and safety assessments through Week 52 were conducted. We also began preparing the application documents for marketing approval.」
After completing transplantation in 8 subjects, the company conducted 26-week efficacy and 52-week safety assessments and began preparing the marketing-approval application. - FY2023First statedAnnual report
「We are advancing research and development into manufacturing methods for human iPS cell-derived cell-processed products. After establishing advanced production technologies capable of producing stable, efficient, safe and reliable cell-processed products, we aim to obtain marketing approval for the products as regenerative medical products.」
The core product is a human iPS cell-derived cardiomyocyte sheet for severe heart failure, with product development and commercialization at the center of the business.