Announced details
Treatment of severe heart failure associated with ischemic heart disease; cardiac regenerative medicine
Average relative change in LVEDVI: 12.4% reduction; average increase in LVEF: 7.3 percentage points; KCCQ-OS: maintained or improved in 7 of 10 patients; six-minute walk test: increased distance in 6 of 9 evaluable patients; NYHA class: maintained or improved in 10 of 10 patients
10 patients enrolled in the LAPiS trial (5 in the low-dose group and 5 in the high-dose group)
The company presented the trial results in an invited lecture at ESC Congress 2026. Capital, personnel and business relationships were not disclosed.
Organizer of the European Society of Cardiology Congress 2026 (ESC Congress 2026). Other details were not disclosed in the documents.
jRCT registration number: 2033210163; ClinicalTrials.gov registration number: 04945018. Registered trademark No. 6932696 for the cardiac spheroids and registered trademark No. 6367938 for SEEDPLANTER. The expiration dates were not disclosed.
5F, Seavans S Building, 1-2-3 Shibaura, Minato-ku, Tokyo
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.
Invited lecture at ESC Congress 2026 (European Society of Cardiology Congress), jRCT, ClinicalTrials.gov, and the Japan Agency for Medical Research and Development (AMED)
| Item | Details |
|---|---|
| Names of Products / Services Covered | Allogeneic iPSC-derived cardiac spheroids (HS-001), SEEDPLANTER® |
| Counterparty | European Society of Cardiology (ESC) |
| Counterparty overview | Organizer of the European Society of Cardiology Congress 2026 (ESC Congress 2026). Other details were not disclosed in the documents. |
| Relationship with the Company | The company presented the trial results in an invited lecture at ESC Congress 2026. Capital, personnel and business relationships were not disclosed. |
| Applicable area | Treatment of severe heart failure associated with ischemic heart disease; cardiac regenerative medicine |
| Registration number and expiry date | jRCT registration number: 2033210163; ClinicalTrials.gov registration number: 04945018. Registered trademark No. 6932696 for the cardiac spheroids and registered trademark No. 6367938 for SEEDPLANTER. The expiration dates were not disclosed. |
| Location | 5F, Seavans S Building, 1-2-3 Shibaura, Minato-ku, Tokyo |
| Quantitative Effects | Average relative change in LVEDVI: 12.4% reduction; average increase in LVEF: 7.3 percentage points; KCCQ-OS: maintained or improved in 7 of 10 patients; six-minute walk test: increased distance in 6 of 9 evaluable patients; NYHA class: maintained or improved in 10 of 10 patients |
| Usage history | 10 patients enrolled in the LAPiS trial (5 in the low-dose group and 5 in the high-dose group) |
| Impact on Business Performance | No revision has been made to the earnings forecast for the fiscal year ending December 2026. |
| Source | Invited lecture at ESC Congress 2026 (European Society of Cardiology Congress), jRCT, ClinicalTrials.gov, and the Japan Agency for Medical Research and Development (AMED) |
Items this document does not state (7)
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 LAPiS trial produced safety and efficacy results supporting the policy toward filing an application for marketing approval.