June 18, 2020

- World’s first BNCT treatment covered by national health insurance system -

TOKYO-Sumitomo Heavy Industries, Ltd. (TOKYO:6302)(President: Shinji Shimomura, referred to as “SHI” hereinafter) announced today, two Japanese BNCT facilities have started clinical treatments by BNCT (Boron Neutron Capture Therapy) ^*1) for an unresectable, locally advanced, and recurrent carcinoma of the head and neck region under the national health insurance system. SHI installed the products at Southern Tohoku BNCT Research Center and Kansai BNCT Research Center and obtained approval of new medical device for manufacturing and sales of accelerator based BNCT system (NeuCure™ System) and the dose calculation program (NeuCure™ Dose Engine) from Japanese Ministry of Health, Labor and Welfare on 11^th March 2020. These products were approved for reimbursement by the national health insurance system on 1^st June 2020.
SHI expects that the cutting-edge products contribute to treatment of cancer patients as the new treatment method.

Features of SHI’s products

NeuCure™ BNCT System
This system uses high current 30MeV proton AVF-cyclotron based on 50-year technical development experience of SHI for medical and physics research fields. SHI has been developing NeuCure™ system since 2007 together with Institute for Integrated Radiation and Nuclear Science, Kyoto University. ^*2) Beryllium is used for the translation from proton to neutron in order to realize safety and reliable system which shall be required by hospitals. And NeuCure™ system has become the world’s first medical system which can be installed in hospitals.

BNCT dose calculation program NeuCure™ Dose Engine
Dose calculation of BNCT essentially requires Monte Carlo method which enables to reproduce reactions between neutron and atoms in human body in detail. NeuCure™ Dose Engine uses PHITS code which was developed by Japan Atomic Energy Agency ^*3). SHI has developed additional functions enabling BNCT dose calculation and data I/F including data security. General functions as a treatment planning system such as; image importing, plan creation, contouring, plan evaluation, and reporting, etc. are provided by means of the combination with RayStation ^*4), which is a product of RaySearch laboratories, AB.

^*1 BNCT is a type of cancer radiotherapy. In this therapy method, a boron medical agent for BNCT is given to cancer patients whereby cancer cells selectively absorb boron (Boron-10). The results is that low-energy neutrons are radiated which in turn causes fission of the boron (Boron-10) nuclei inside the body. This reaction releases α particles (helium nuclei) and Li recoil nuclei (lithium nuclei), which possess enough energy to damage cancer cells. The range of these charged particles is approximately 9μm and 4μm respectively. This range is approximately the size of a cancer cell. This makes it possible to selectively destroy cancer cells, which have absorbed the boron (Boron-10), while minimizing damage to surrounding healthy cells.

^*2 SHI has been developing accelerator based BNCT system together with Integrated Radiation and Nuclear Science, Kyoto University since 2007. In 2009, SHI installed the first system in the institute. In 2015, SHI installed the second system in Southern Tohoku Hospital, Fukushima, and in 2019, SHI installed the third system in Osaka medical college, Osaka. On the other hands, SHI started phase II clinical trial in 2016 together with the partners following preclinical and phase I clinical trial. In 2017, this project was specified as one of the subjects for SAKIGAKE Designation System.

^*3 PHITS (Particle and Heavy Ion Transport code System) is well known Monte Carlo calculation code developed by Japan Atomic Energy Agency (JAEA). It has many references of research for the simulation of various radiation behavior and it has more than 4,000 users globally,

^*4 RayStation is an advanced treatment planning system which has been marketed by RaySearch laboratories, AB (Stockholm, Sweden), who is a medical technology company that develops advanced software solutions for improved radiation therapy of cancer. RayStation is used at clinics all over the world in good reputation because of its flexible platform with advanced tools including optimization tool. RaySearch’s products are distributed through licensing agreements with leading medical technology companies. RaySearch’s software is used by over 2,600 clinics in more than 65 countries. RaySearch was founded in 2000 as a spin-off from the Karolinska Institute in Stockholm.