Announced details
Treatment of severe heart failure caused by ischemic cardiomyopathy inadequately controlled by standard drug therapy. Eligible patients are those who have undergone coronary artery bypass grafting (CABG) and have a left ventricular ejection fraction (LVEF) of 40% or less at rest.
The Ministry of Health, Labour and Welfare designated HS-001 as a product covered by the “pioneering regenerative medical products” designation.
Pioneering regenerative medical products
Ministry of Health, Labour and Welfare
Designation date: 9 November 2026. Expiration date and registration number: not disclosed.
No revision has been made to the earnings forecast for the fiscal year ending December 2026.
The company does not address Contract Value / Offering price.
| Item | Details |
|---|---|
| Names of Products / Services Covered | Allogeneic iPS cell-derived cardiac muscle spheroid “HS-001”, remumiocel |
| Counterparty | Ministry of Health, Labour and Welfare |
| Relationship with the Company | The Ministry of Health, Labour and Welfare designated HS-001 as a product covered by the “pioneering regenerative medical products” designation. |
| Applicable area | Treatment of severe heart failure caused by ischemic cardiomyopathy inadequately controlled by standard drug therapy. Eligible patients are those who have undergone coronary artery bypass grafting (CABG) and have a left ventricular ejection fraction (LVEF) of 40% or less at rest. |
| Award/certification name | Pioneering regenerative medical products |
| Awarding / certifying body | Ministry of Health, Labour and Welfare |
| Registration number and expiry date | Designation date: 9 November 2026. Expiration date and registration number: not disclosed. |
| Impact on Business Performance | No revision has been made to the earnings forecast for the fiscal year ending December 2026. |
Items this document does not state (10)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Under a development promotion program designed to accelerate the practical application of regenerative medical products in Japan, government support measures including priority consultation, preliminary evaluation and priority review apply.