Sumitomo Heavy Industries, Ltd. Obtains Medical Device Approval for Manufacturing and Sales of Accelerator Based BNCT System and the Dose Calculation Program in Japan

- World’s first BNCT systems as medical device -

Accelerator based BNCT system and its cyclotron (Graphic: Business Wire)

TOKYO--()--Sumitomo Heavy Industries, Ltd. (TOKYO:6302)(President: Shinji Shimomura, referred as SHI hereinafter) has performed clinical trial of the BNCT*1) (Boron Neutron Capture Therapy) system using an accelerator (cyclotron), targeting carcinoma of the head and neck region in collaboration with STELLA PHARMA CORPORATION (President: Tomoyuki Asano). And SHI has applied the system for new medical device approval on 11th October, 2019. Today, we would like to announce that Sumitomo Heavy Industries, Ltd. obtains new medical device approval for manufacturing and sales of accelerator based BNCT system (NeuCureTM System) and the dose calculation program (NeuCureTM Dose Engine) from Japanese Ministry of Health, Labor and Welfare. These are the world’s first medical devices for BNCT.

Market and SHI’s target

BNCT is unique radiation therapy method which is led by Japanese researchers. SHI believes better treatment will be provided to patients in the world. Once STELLA PHARMA CORPORATION obtains the drug application approval, SHI would like to develop BNCT market globally together with partners by means of sending information of BNCT and the clinical outcome to the world. It may take years for obtaining global common recognition. However, SHI would like to install more than 100 systems globally as a long term target. SHI will keep making efforts to improve and develop NeuCureTM system and NeuCureTM Dose Engine.

Contacts

Sumitomo Heavy Industries, Ltd.
Corporate Communication Dept.
Takuto Ono, +81-3-6737-2332
shi.zshi_koho@shi-g.com

Release Summary

SHI has performed clinical trial of the BNCT system using an accelerator, targeting carcinoma of the head and neck region

Contacts

Sumitomo Heavy Industries, Ltd.
Corporate Communication Dept.
Takuto Ono, +81-3-6737-2332
shi.zshi_koho@shi-g.com