First patient dosing in the Phase 1/2 company-sponsored clinical trial of HS-005 cardiac regenerative therapy (catheter administration)
Heartseed Inc.
HS-005 (catheter administration of allogeneic iPS cell-derived cardiomyocyte spheroids), EMERALD trial, Shinshu University Hospital, and the cohort of patients with heart failure due to dilated cardiomyopathy
No revision has been made to the forecast for the fiscal year ending December 2026.
Related procedures
Domestic Phase 1/2 company-sponsored clinical trial
Company response
The Independent Safety Evaluation Committee evaluated the four-week post-dose data and approved continuation of the clinical trial in the dilated cardiomyopathy cohort. The chair's name and establishment date are Not disclosed.
The company will confirm safety and efficacy in the planned 14-patient study, comprising 7 patients in the ischemic heart disease cohort and 7 patients in the dilated cardiomyopathy cohort, and continue the clinical evaluation of HS-005.
| Item | Details |
|---|---|
| Event name | First patient dosing in the Phase 1/2 company-sponsored clinical trial of HS-005 cardiac regenerative therapy (catheter administration) |
| Date of occurrence | Late March 2026 (the first patient was dosed at Shinshu University Hospital; specific date Not disclosed) |
| Subject Entity | Heartseed Inc. |
| Target Locations / Products | HS-005 (catheter administration of allogeneic iPS cell-derived cardiomyocyte spheroids), EMERALD trial, Shinshu University Hospital, and the cohort of patients with heart failure due to dilated cardiomyopathy |
| Impact on Earnings Forecast | No revision has been made to the forecast for the fiscal year ending December 2026. |
| Type of litigation or proceeding | Domestic Phase 1/2 company-sponsored clinical trial |
| Investigation structure | The Independent Safety Evaluation Committee evaluated the four-week post-dose data and approved continuation of the clinical trial in the dilated cardiomyopathy cohort. The chair's name and establishment date are Not disclosed. |
| Outlook | The company will confirm safety and efficacy in the planned 14-patient study, comprising 7 patients in the ischemic heart disease cohort and 7 patients in the dilated cardiomyopathy cohort, and continue the clinical evaluation of HS-005. |
Items this document does not state (17)
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.To confirm the safety and efficacy of dosing while seeking to expand the indication to dilated cardiomyopathy in addition to ischemic heart disease.