First administration in the ischemic heart disease cohort of the Phase 1/2 company-sponsored clinical trial of cardiac regenerative medicine HS-005 (catheter administration)
Heartseed Inc. (the Company)
HS-005 (allogeneic iPS cell-derived cardiomyocyte spheroids; administration using a catheter or other device) / EMERALD trial / ischemic heart disease cohort
There is no change to the earnings forecast for the fiscal year ending December 2026.
Company response
The Independent Safety Evaluation Committee approved continuation of the clinical trial in the cohort based on data from 4 weeks after dosing (chairperson's name and establishment date: Not disclosed)
Following approval by the Independent Safety Evaluation Committee, the clinical trial in the ischemic heart disease cohort will continue.
| Item | Details |
|---|---|
| Event name | First administration in the ischemic heart disease cohort of the Phase 1/2 company-sponsored clinical trial of cardiac regenerative medicine HS-005 (catheter administration) |
| Subject Entity | Heartseed Inc. (the Company) |
| Target Locations / Products | HS-005 (allogeneic iPS cell-derived cardiomyocyte spheroids; administration using a catheter or other device) / EMERALD trial / ischemic heart disease cohort |
| Impact on Earnings Forecast | There is no change to the earnings forecast for the fiscal year ending December 2026. |
| Investigation structure | The Independent Safety Evaluation Committee approved continuation of the clinical trial in the cohort based on data from 4 weeks after dosing (chairperson's name and establishment date: Not disclosed) |
| Outlook | Following approval by the Independent Safety Evaluation Committee, the clinical trial in the ischemic heart disease cohort will continue. |
Items this document does not state (19)
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 Independent Safety Evaluation Committee approved continuation of the clinical trial in the cohort based on data from 4 weeks after dosing.