Worth reading
28Immaterial
0–100. This measures how worthwhile something is to read, not how good or bad the company is.Direction
Improvement
Direction inferred from the company’s description.Scale
10
Cases (completion of dosing in the HS-001 LAPiS trial)Wording
Conditional
How definitive the wording is.Items stated in the management plan
Annual updateKey initiatives
01Early launch of myocardial replacement therapy in Japan
02Penetrate global markets with a less invasive myocardial replacement therapy
03Develop tailor-made medicine using autologous iPS cells
04Expand into other regenerative medicine fields
05Jointly develop a catheter system with Japan Lifeline Co., Ltd.
Plan assumptions65 million heart failure patients worldwide; target patient population of approximately 7 million, 20% applicability rate for HS-001 in Japan, 60% applicability rate for HS-005 in dilated cardiomyopathy and 10% applicability rate in ischemic heart disease, These figures are estimates and assumptions by the Company and may differ materially from actual results
Non-financial targetsIndicator name Number of cases dosed in the HS-001 LAPiS trial / Target value 5 cases at the low dose, 5 cases at the high dose, 10 cases in total / Timing Dosing completed for all 10 cases as of March 2026, Indicator name HS-001 marketing authorization application / Target value Marketing authorization application / Timing By the end of 2026, Indicator name Number of cases in the HS-005 EMERALD trial / Target value 7 cases of ischemic heart disease, 7 cases of dilated cardiomyopathy, 14 cases in total / Timing Preparations underway to begin dosing in 2026
Size of the Target MarketHeart Failure Patients 65 million worldwide / Target Patient Population Approximately 7 million / Applicable Patients in Japan HS-001 3,400 people / HS-005: Dilated Cardiomyopathy 12,000 people / HS-005: Ischemic Heart Disease 16,000 people / Applicable Patients in the United States HS-005: Dilated Cardiomyopathy 48,000 people / HS-005: Ischemic Heart Disease 70,000 people / Growth rate Not disclosed / Source N.L. Bragazzi et al., ESC European Journal of Preventive Cardiology 2020, Number of patients classified as III–IV under the NYHA classification: pubmed.ncbi.nlm.nih.gov/33760037/, Japanese Registry Of All cardiac and vascular Diseases, Survey of Actual Cardiovascular Disease Care (February 2025), Guidelines for the Diagnosis and Treatment of Cardiomyopathies (2018 revised edition), Reports from research firms commissioned by Heartseed and materials obtained from its partners
| Item | Details |
|---|---|
| Plan name | Business Plan and Growth Potential |
| Progress against the plan | Annual update |
| Non-financial targets | Indicator name Number of cases dosed in the HS-001 LAPiS trial / Target value 5 cases at the low dose, 5 cases at the high dose, 10 cases in total / Timing Dosing completed for all 10 cases as of March 2026, Indicator name HS-001 marketing authorization application / Target value Marketing authorization application / Timing By the end of 2026, Indicator name Number of cases in the HS-005 EMERALD trial / Target value 7 cases of ischemic heart disease, 7 cases of dilated cardiomyopathy, 14 cases in total / Timing Preparations underway to begin dosing in 2026 |
| Plan assumptions | 65 million heart failure patients worldwide; target patient population of approximately 7 million, 20% applicability rate for HS-001 in Japan, 60% applicability rate for HS-005 in dilated cardiomyopathy and 10% applicability rate in ischemic heart disease, These figures are estimates and assumptions by the Company and may differ materially from actual results |
| Key initiatives | Early launch of myocardial replacement therapy in Japan, Penetrate global markets with a less invasive myocardial replacement therapy, Develop tailor-made medicine using autologous iPS cells, Expand into other regenerative medicine fields, Jointly develop a catheter system with Japan Lifeline Co., Ltd. |
| Size of the Target Market | Heart Failure Patients 65 million worldwide / Target Patient Population Approximately 7 million / Applicable Patients in Japan HS-001 3,400 people / HS-005: Dilated Cardiomyopathy 12,000 people / HS-005: Ischemic Heart Disease 16,000 people / Applicable Patients in the United States HS-005: Dilated Cardiomyopathy 48,000 people / HS-005: Ischemic Heart Disease 70,000 people / Growth rate Not disclosed / Source N.L. Bragazzi et al., ESC European Journal of Preventive Cardiology 2020, Number of patients classified as III–IV under the NYHA classification: pubmed.ncbi.nlm.nih.gov/33760037/, Japanese Registry Of All cardiac and vascular Diseases, Survey of Actual Cardiovascular Disease Care (February 2025), Guidelines for the Diagnosis and Treatment of Cardiomyopathies (2018 revised edition), Reports from research firms commissioned by Heartseed and materials obtained from its partners |
Items this document does not state (19)
Plan periodSales TargetOperating profit targetOperating profit margin targetNet income targetROE targetROIC targetPayout ratio / DOE policyTreasury share acquisition policyCost of capitalSelf-assessment of PBR and share priceTotal investment planInvestment amount by sectorSegment targetResults under the previous planReason for revision or withdrawalRisks identifiedDate of board resolutionPublication date
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 establish proof of concept for the efficacy and safety of myocardial cell transplantation with HS-001 and pursue an early launch in Japan, while using HS-005 to bring a less invasive myocardial replacement therapy to markets worldwide, not only Japan.
How to read this page
This is not the documentKomori reads the disclosure the company filed and writes this summary. Figures are as stated by the company and are not audited.
Weight is not a verdictIt measures how much this changes what the company had already told the market. It is not a view on the shares.
Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.