CICS Co., Ltd. (a consolidated subsidiary of Resorttrust, Inc.) Announces Application for Manufacturing and Marketing Approval of Accelerator-based BNCT Treatment System as Medical Device
CICS Co., Ltd., a consolidated subsidiary of Resorttrust, Inc., announced that it has applied for manufacturing and marketing approval for its accelerator-based Boron Neutron Capture Therapy (BNCT) neutron irradiation system, "CICS-1," as of April 30, 2026. This application is based on the results of a domestic Phase II clinical trial for cutaneous angiosarcoma, and due to its designation as an orphan medical device, rapid provision to medical sites is expected.
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- 📰 Published: May 1, 2026 at 01:00
- 🔍 Collected: April 30, 2026 at 16:31
- 🤖 AI Analyzed: April 30, 2026 at 17:05 (33 min after Collected)
CICS Co., Ltd. (Representative Director and President: Tetsuya Furukawa; Headquarters: Koto-ku, Tokyo; hereinafter "CICS"), a consolidated subsidiary of Resorttrust, Inc., announced that it has applied for manufacturing and marketing approval for its accelerator-based Boron Neutron Capture Therapy (BNCT) neutron irradiation system, "CICS-1" (hereinafter "this system"), as of April 30, 2026. This application is based on the results of a domestic Phase II clinical trial (hereinafter "this trial") targeting intractable cutaneous angiosarcoma*1.
This trial was conducted at the National Cancer Center Hospital, using this system and Stella Pharma's boron drug (SPM-011) for intractable cutaneous angiosarcoma.
This system was designated as an "orphan medical device" for cutaneous angiosarcoma by the Ministry of Health, Labour and Welfare in 2023, making it eligible for priority review. Therefore, it is expected to be rapidly provided to medical sites. Furthermore, the impact of this matter on our consolidated performance for the current fiscal year is minor.
The Resorttrust Group entered the medical business in 1994, starting the operation of a membership-based comprehensive medical club. At Yamanakako Clinic, Positron Emission Tomography (PET), which was then a research device, was introduced for cancer screening, greatly contributing to the widespread use of PET in Japan. Currently, in addition to screening, we are expanding solutions in treatment and supporting the operation of advanced immune therapy facilities for cancer. Also, under the brand identity of "Let's share a good life together," and with the desire to "create a society where no one loses loved ones to cancer," we have been involved in cancer screening and treatment. Moving forward, we aim to bring new hope to cancer treatment both in Japan and internationally, with a focus on the entire Asian region.
*1 About Angiosarcoma
It is a cancer that originates from the endothelial cells of blood vessels. It can occur anywhere in the body, but most commonly appears on the skin. It is considered a very rare and highly malignant cancer, and effective treatment methods have not yet been established.
【About BNCT】
BNCT is a type of radiation therapy and a new cancer treatment method. When a boron drug is administered to the patient, boron (10B) accumulates in cancer cells. Subsequently, the affected area is irradiated with neutron beams from outside the body. The neutron beams used have very low energy and have almost no effect on the human body, but when they collide with boron (10B), a nuclear reaction occurs, generating radiation (alpha particles and 7Li nuclei). This radiation selectively destroys cancer cells. Furthermore, treatment is generally completed with a single neutron beam irradiation, making it a promising treatment method with less burden on the body.
【About CICS-1】
CICS-1 is an accelerator-based neutron irradiation device for Boron Neutron Capture Therapy, jointly developed by CICS and the National Cancer Center Hospital. It generates neutrons by colliding protons accelerated by an RFQ (Radio Frequency Quadrupole) linear accelerator with a lithium target. A key feature is the minimal admixture of high-speed neutrons, which have harmful effects on the human body. Additionally, since the generated neutron energy is low, below 800keV, it has enabled the miniaturization of the moderator system to decelerate neutrons to approximately 10keV, suitable for BNCT. Unlike existing devices that irradiate neutrons horizontally to the patient, CICS's device can irradiate vertically, making it applicable to diseases that were previously difficult to irradiate.
CICS-1 BNCT Irradiation Room at National Cancer Center Hospital
This trial was conducted at the National Cancer Center Hospital, using this system and Stella Pharma's boron drug (SPM-011) for intractable cutaneous angiosarcoma.
This system was designated as an "orphan medical device" for cutaneous angiosarcoma by the Ministry of Health, Labour and Welfare in 2023, making it eligible for priority review. Therefore, it is expected to be rapidly provided to medical sites. Furthermore, the impact of this matter on our consolidated performance for the current fiscal year is minor.
The Resorttrust Group entered the medical business in 1994, starting the operation of a membership-based comprehensive medical club. At Yamanakako Clinic, Positron Emission Tomography (PET), which was then a research device, was introduced for cancer screening, greatly contributing to the widespread use of PET in Japan. Currently, in addition to screening, we are expanding solutions in treatment and supporting the operation of advanced immune therapy facilities for cancer. Also, under the brand identity of "Let's share a good life together," and with the desire to "create a society where no one loses loved ones to cancer," we have been involved in cancer screening and treatment. Moving forward, we aim to bring new hope to cancer treatment both in Japan and internationally, with a focus on the entire Asian region.
*1 About Angiosarcoma
It is a cancer that originates from the endothelial cells of blood vessels. It can occur anywhere in the body, but most commonly appears on the skin. It is considered a very rare and highly malignant cancer, and effective treatment methods have not yet been established.
【About BNCT】
BNCT is a type of radiation therapy and a new cancer treatment method. When a boron drug is administered to the patient, boron (10B) accumulates in cancer cells. Subsequently, the affected area is irradiated with neutron beams from outside the body. The neutron beams used have very low energy and have almost no effect on the human body, but when they collide with boron (10B), a nuclear reaction occurs, generating radiation (alpha particles and 7Li nuclei). This radiation selectively destroys cancer cells. Furthermore, treatment is generally completed with a single neutron beam irradiation, making it a promising treatment method with less burden on the body.
【About CICS-1】
CICS-1 is an accelerator-based neutron irradiation device for Boron Neutron Capture Therapy, jointly developed by CICS and the National Cancer Center Hospital. It generates neutrons by colliding protons accelerated by an RFQ (Radio Frequency Quadrupole) linear accelerator with a lithium target. A key feature is the minimal admixture of high-speed neutrons, which have harmful effects on the human body. Additionally, since the generated neutron energy is low, below 800keV, it has enabled the miniaturization of the moderator system to decelerate neutrons to approximately 10keV, suitable for BNCT. Unlike existing devices that irradiate neutrons horizontally to the patient, CICS's device can irradiate vertically, making it applicable to diseases that were previously difficult to irradiate.
CICS-1 BNCT Irradiation Room at National Cancer Center Hospital