Announced details
Severe heart failure associated with ischemic heart disease
Results across multiple endpoints relating to cardiac pump function and reduction in the enlarged heart supported the Company's policy of seeking a marketing authorization application.
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.
Readout data, including imaging assessments conducted by an independent third-party organization
| Item | Details |
|---|---|
| Names of Products / Services Covered | Allogeneic iPSC-derived cardiac spheroids (HS-001) |
| Applicable area | Severe heart failure associated with ischemic heart disease |
| Quantitative Effects | Results across multiple endpoints relating to cardiac pump function and reduction in the enlarged heart supported the Company's policy of seeking a marketing authorization application. |
| Impact on Business Performance | No revision has been made to the earnings forecast for the fiscal year ending December 2026. |
| Source | Readout data, including imaging assessments conducted by an independent third-party organization |
Items this document does not state (13)
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.The prespecified analyses for the LAPiS Trial and the verification of readout data, including imaging assessments conducted by an independent third-party organization, have been completed.