March 10, 2025

Sumitomo Heavy Industries, Ltd. (Head Office: Shinagawa-ku, Tokyo; Representative Director, President, and CEO: Shinji Shimomura; hereinafter referred to as “SHI”) announces that “NeuCure^®” and “NeuCure^® Dose Engine” (hereinafter referred to as the “Products”) have received orphan medical device designations as of December 9, 2024. “NeuCure^®” is a boron neutron capture therapy (BNCT) system that utilizes medical accelerator technology and experience in BNCT for aiming at treating of refractory cancer. “NeuCure^® Dose Engine” is a BNCT dose calculation program.

The Products have already been approved as medical devices and are reimbursed by national health insurance for the treatment of unresectable locally advanced or locally recurrent head and neck cancer. Now the Products have also received orphan device designations from the Ministry of Health, Labour and Welfare (MHLW) for recurrent malignant glioma and recurrent meningioma.

The orphan device designation system is designed to support the development of medical devices for which there is a high demand in medicine, but which are not being researched and developed in large numbers due to the small number of patients. The conditions for receiving this designation are: (1) the number of target patients does not reach 50,000 in Japan, (2) there is no suitable alternative medical device or treatment method, or the device is expected to have significantly higher efficacy or safety compared to existing medical devices, and (3) there is evidence that the device is suitable for use in treating treat the target disease, and the development plan is reasonable.
Designation as an orphan device entitles the applicant to benefits such as priority clinical trial consultation and review, subsidies for test and research expenses, and preferential tax treatment.

SHI is developing BNCT for the two additional designated diseases, and has completed the observation period for recurrent meningiomas in a Phase II investigator-initiated clinical trial in recurrent high-grade meningiomas. We will continue to focus its efforts on the further popularization of BNCT and on expanded its indications.