Announced details
BNCT treatment for unresectable cutaneous angiosarcoma
Neutron energy of 800 keV or less; approximately 10 keV after moderation, an energy level suitable for BNCT
CICS is a consolidated subsidiary of RESORTTRUST,INC. CICS-1 was jointly developed by CICS and National Cancer Center Hospital. The clinical trial was conducted using CICS-1 and Stella Pharma’s SPM-011.
National Cancer Center Hospital is the medical institution where the clinical trial was conducted. Stella Pharma provides the boron agent “SPM-011.” Other information: not disclosed
Designation as an orphan medical device
Ministry of Health, Labour and Welfare
not disclosed (designated in 2023)
株式会社CICS head office: 17F, TOC Ariake West Tower, 3-5-7 Ariake, Koto-ku, Tokyo. Clinical trial site: National Cancer Center Hospital
The impact on the consolidated results for the current fiscal year is expected to be immaterial.
The company does not address Contract Value / Offering price.
| Item | Details |
|---|---|
| Names of Products / Services Covered | Accelerator-based neutron irradiation device for boron neutron capture therapy (BNCT), “CICS-1”; boron agent “SPM-011” |
| Counterparty | Stella Pharma, National Cancer Center Hospital |
| Counterparty overview | National Cancer Center Hospital is the medical institution where the clinical trial was conducted. Stella Pharma provides the boron agent “SPM-011.” Other information: not disclosed |
| Relationship with the Company | CICS is a consolidated subsidiary of RESORTTRUST,INC. CICS-1 was jointly developed by CICS and National Cancer Center Hospital. The clinical trial was conducted using CICS-1 and Stella Pharma’s SPM-011. |
| Launch date | not disclosed (application date: 30 April 2026; timing of provision has not been determined) |
| Applicable area | BNCT treatment for unresectable cutaneous angiosarcoma |
| Award/certification name | Designation as an orphan medical device |
| Awarding / certifying body | Ministry of Health, Labour and Welfare |
| Registration number and expiry date | not disclosed (designated in 2023) |
| Location | 株式会社CICS head office: 17F, TOC Ariake West Tower, 3-5-7 Ariake, Koto-ku, Tokyo. Clinical trial site: National Cancer Center Hospital |
| Quantitative Effects | Neutron energy of 800 keV or less; approximately 10 keV after moderation, an energy level suitable for BNCT |
| Impact on Business Performance | The impact on the consolidated results for the current fiscal year is expected to be immaterial. |
Items this document does not state (6)
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 application for marketing approval was filed based on the results of a domestic Phase II clinical trial for cutaneous angiosarcoma. CICS-1 has been designated as an orphan medical device and is eligible for priority review, and the company expects this will enable the device to be provided to medical institutions promptly.