Application for domestic manufacturing and marketing approval for a cardiac muscle cell sheet for ischemic heart disease
First written in FY2023. 3 of 7 entries say "Restated". Latest entry: FY2025.
No other company in this theme has enough history to compare yet.
- FY2025AchievedAnnual report
「After completing transplantation in these 8 subjects, we conducted efficacy assessments through Week 26 and safety assessments through Week 52 and performed statistical analysis of the trial data. Based on the results, we prepared the marketing-approval application materials for submission to the Ministry of Health, Labour and Welfare. We submitted the application materials to the Ministry in April 2025.」
The domestic marketing-approval application materials for ischemic heart disease were submitted in April 2025, completing the submission milestone. Approval had not yet been obtained. - 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 entered the stage of incorporating long-term data into the application materials and consulting with PMDA. The application had not yet been submitted. - FY2024RestatedAnnual report
「During the consolidated fiscal year under review, we conducted 26-week efficacy assessments, safety assessments through Week 52, statistical analysis of the trial data and other work after transplantation, and proceeded with preparations for the marketing-approval application.」
Evaluation, analysis and application work continued toward the domestic marketing-approval application, with no new milestone such as submission reported. - FY2024-Q3RestatedAnnual report
「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 designated early submission of the marketing-approval application as our top priority, concentrated management resources on it, and handled the application process.」
Assessments and application work continued. No specific new milestone, such as completion or submission of the application, was reported from the previous quarter. - FY2024-Q2RestatedAnnual report
「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.」
Assessments and preparation of the application documents continued, but no new milestone such as submission was reported. - FY2024-Q1AdvancedAnnual report
「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.」
The company moved from evaluating the clinical-trial data to preparing the domestic marketing-approval application. - FY2023First statedAnnual report
「Our most advanced development program is the human iPS cell-derived cardiomyocyte sheet for ischemic heart disease (ICM), for which an investigator-initiated clinical trial is being conducted. We are focusing on submitting the application for marketing approval.」
The company planned to submit the application promptly after completing transplantation in 8 subjects and conducting statistical analysis and other procedures.