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 -

TOKYO--(BUSINESS WIRE)--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 11^th 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 (NeuCure^TM System) and the dose calculation program (NeuCure^TM 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 NeuCure^TM system and NeuCure^TM Dose Engine.