Expansion of indications for JACC autologous cultured cartilage to secondary osteoarthritis of the knee
First written in FY2019-Q1. 7 of 20 entries say "Restated". Latest entry: FY2026.
No other company in this theme has enough history to compare yet.
- FY2026AchievedAnnual report
「JACC autologous cultured cartilage obtained approval for partial changes in May 2025 to add osteoarthritis of the knee as an indication, and was listed for reimbursement in January 2026.」
For the expansion of JACC indications to osteoarthritis of the knee, the company achieved reimbursement listing in January 2026 following approval. - FY2026-H1AdvancedAnnual report
「Toward expanding indications to osteoarthritis of the knee, we are steadily advancing discussions with the Ministry of Health, Labour and Welfare with the aim of obtaining reimbursement listing during the third quarter of the fiscal year ending March 2026. Briefings and other activities for medical institutions highlighting efficacy and safety are also progressing smoothly so that product supply can begin promptly after reimbursement listing.」
Following approval obtained in May 2025 for the expansion of JACC indications to osteoarthritis of the knee, the company progressed to the discussion stage targeting reimbursement listing during the third quarter of the fiscal year ending March 2026, and briefings for medical institutions after reimbursement listing are also progressing. - FY2025AchievedAnnual report
「JACC autologous cultured cartilage obtained approval for partial changes to add osteoarthritis of the knee as a new indication, effective 13 May 2025. Going forward, we will build the supply structure with the aim of obtaining reimbursement listing during the fiscal year ending March 2026.」
For the expansion of JACC indications to osteoarthritis of the knee, the company obtained approval for partial changes effective 13 May 2025, achieving its target of obtaining approval for the expanded indication. Reimbursement listing and establishment of the supply structure remain ongoing tasks. - FY2025-H1AdvancedAnnual report
「On 17 June 2024, we submitted to the Ministry of Health, Labour and Welfare an application for partial change approval to expand the indications for JACC autologous cultured cartilage to include osteoarthritis of the knee. We are targeting a launch in the fiscal year ending March 2026 and are also preparing to strengthen our manufacturing system ahead of increased sales.」
For the expansion of JACC indications to osteoarthritis of the knee, following submission of the application for partial changes to the marketing approval in June 2024, the company specified a launch target for the fiscal year ending March 2026 and strengthening of its manufacturing structure in preparation for higher sales. - FY2024AdvancedAnnual report
「We conducted a clinical trial from July 2018 to expand indications to osteoarthritis of the knee and submitted a clinical trial completion notification to the Pharmaceuticals and Medical Devices Agency (PMDA) in February 2024. In this study, statistically significant improvement in clinical symptoms was demonstrated, and repair with hyaline cartilage-like tissue was confirmed at cartilage defects caused by osteoarthritis of the knee. We compiled these data and submitted an application for partial changes to the marketing approval to PMDA in June 2024.」
For the expansion of JACC indications to osteoarthritis of the knee, the company progressed through submission of the clinical trial completion notification, confirmation of improvement in clinical symptoms and tissue repair, and submission of the application for partial changes to the marketing approval in June 2024. - FY2024-Q2AdvancedAnnual report
「We are conducting a clinical trial for secondary osteoarthritis of the knee caused by trauma and other factors in preparation for expanding JACC indications. The trial is progressing as planned, treatment of the final patient has been completed, and follow-up of all patients has been completed. We will promptly compile the data and prepare the application.」
The clinical trial to expand indications to secondary osteoarthritis of the knee progressed to the stage of preparing the marketing approval application after treatment of the final patient and follow-up of all patients were completed. - FY2023-Q2AdvancedAnnual report
「We are conducting a clinical trial with the aim of expanding indications to secondary osteoarthritis of the knee caused by trauma. The trial is progressing as planned, and we will promptly compile the data and prepare the application.」
The clinical trial to expand JACC indications to secondary osteoarthritis of the knee progressed as planned to the stage of compiling data and preparing the marketing approval application. - FY2023-Q1RestatedAnnual report
「We are conducting a clinical trial for secondary osteoarthritis of the knee caused by trauma and other factors in preparation for expanding JACC indications. Through this expansion, we aim to enter a market with a large target patient population.」
The company continues the clinical trial to expand JACC indications to secondary osteoarthritis of the knee and its target of entering a market with a large target patient population. - FY2022-Q1RestatedAnnual report
「We are conducting a clinical trial for secondary osteoarthritis of the knee caused by trauma and other factors in preparation for expanding JACC indications. Through this expansion, we aim to enter a market with a large target patient population.」
The company continues the clinical trial to expand JACC indications to secondary osteoarthritis of the knee and its market expansion target. - FY2021-Q2RestatedAnnual report
「Although progress has been delayed compared with the plan due to a decline in outpatients, we are conducting a clinical trial for secondary osteoarthritis of the knee caused by trauma and other factors and will continue working to expand the JACC market.」
The clinical trial to expand JACC indications to secondary osteoarthritis of the knee is behind schedule, but the company continues the trial and its market expansion policy. - FY2021-Q1SoftenedAnnual report
「Although progress has been delayed compared with the plan due to a decline in outpatients, we are conducting a clinical trial for secondary osteoarthritis of the knee caused by trauma and other factors and will continue working to expand the JACC market.」
The clinical trial to expand JACC indications to secondary osteoarthritis of the knee continues, but has been delayed compared with the plan due to a decline in outpatients. - FY2020RestatedAnnual report
「We are conducting a clinical trial for secondary osteoarthritis of the knee caused by trauma and other factors and will continue working to expand the JACC market.」
For the expansion of JACC indications to secondary osteoarthritis of the knee, the company continues the clinical trial and its market expansion target. - FY2020-Q3RestatedAnnual report
「We are conducting a clinical trial for secondary osteoarthritis of the knee caused by trauma and other factors and will continue working to expand the JACC market.」
For the expansion of JACC indications to secondary osteoarthritis of the knee, the company continues the clinical trial and its market expansion target. - FY2020-Q2RestatedAnnual report
「We are also conducting a clinical trial for secondary osteoarthritis of the knee caused by trauma and other factors, and will continue working to expand the JACC market.」
For the expansion of JACC indications to secondary osteoarthritis of the knee, the company continues the clinical trial and its market expansion target. - FY2019-Q3AdvancedAnnual report
「Also, in July, we submitted a clinical trial notification for an expansion of indications to include secondary osteoarthritis of the knee caused by trauma and other factors, and are currently conducting the clinical trial.」
For the expansion of JACC indications to secondary osteoarthritis of the knee, the company progressed to the clinical trial stage after submitting the clinical trial notification. - FY2019-Q2RestatedAnnual report
「Also, in July, we submitted a clinical trial notification for an expansion of indications to include secondary osteoarthritis of the knee caused by trauma and other factors, and will aim to further promote JACC and expand its market.」
For the expansion of JACC indications to secondary osteoarthritis of the knee, the company continues to pursue the July 2018 submission of the clinical trial notification and its market expansion target. - FY2019-Q1First statedAnnual report
「Also, in July 2018, we submitted a clinical trial notification for an expansion of indications to include secondary osteoarthritis of the knee caused by trauma and other factors, in preparation for future sales growth.」
For JACC, a clinical trial notification was submitted in July 2018 to expand indications to secondary osteoarthritis of the knee caused by trauma and other factors.