Sumitomo Heavy Industries, Ltd. (Headquarters: Shinagawa-ku, Tokyo; President and CEO: Shinji Shimomura; hereinafter "SWI") has invested in Soundwave Innovation Inc. (Headquarters: Chuo-ku, Tokyo; President and CEO: Hiroaki Shimokawa; hereinafter "SWI"), a university-originated DeepTech startup aiming to implement a therapeutic device for early Alzheimer's disease, through a third-party allotment of new shares.
At the same time, the two companies have entered into a strategic business partnership agreement for the manufacture and sale of the "LIPUS-Brain" transcranial low-intensity pulsed ultrasound therapy device for early Alzheimer's disease patients.
[1. Background and Purpose of the Investment and Business Partnership]
Due to the global aging population, dementia, including Alzheimer's disease, has become a social issue in the medical and welfare fields. Dementia not only places a burden on patients, but also significantly impacts the lives of their families and caregivers. There is a strong demand for new treatment options that contribute to improving quality of life (QOL).
In our "Medium-Term Management Plan 2026," we have identified strengthening our new business exploration capabilities as one of our key priorities, aiming to "build a resilient business entity." This investment is part of our new business exploration efforts in the "advanced medical equipment field," one of our four key investment areas (*1) where we are concentrating our management resources.
By combining the technical capabilities we have cultivated over many years in the manufacture of medical devices such as cancer diagnostic and treatment equipment with the innovative technologies of DeepTech startups, we will work to rapidly develop and provide products.
We will continue to explore new businesses in areas surrounding our core business, such as this one, and through investments and business partnerships with startups, we will expand into new business areas, address social issues, and strengthen our revenue structure.
This investment and business partnership with SWI will involve participation in minimally invasive (*3) treatment for dementia using low-intensity pulsed ultrasound (LIPUS) (*2). In the future, we also aim to participate in the research and development of innovative medical devices for diseases such as severe angina and arrhythmias, which SWI is working on (Figure 1).
The safety of the "LIPUS-Brain" transcranial low-intensity pulsed ultrasound treatment device for early-stage Alzheimer's disease patients, which we have partnered on, was confirmed in an exploratory clinical trial led by Professor Emeritus Hiroaki Shimokawa of Tohoku University, which concluded in 2022, with results suggesting its effectiveness.
Following these results, the device was designated as the first "pioneering medical device" by the Ministry of Health, Labour and Welfare in September of the same year (*4). Confirmatory clinical trials began in October 2023, and the target number of registered cases was achieved by November 2024, progressing as planned.
Through this partnership, both companies will leverage their respective strengths to jointly promote manufacturing and sales of SWI's LIPUS technology, aiming to provide society with a new medical option for Alzheimer's disease treatment, thereby contributing to improving the quality of life of patients and their families.
[2. Overview of the Investment and Business Alliance and Future Outlook]
SWI will conduct confirmatory clinical trials for the treatment and license intellectual property related to the device, while the Company will manufacture and sell the device.
The confirmatory clinical trials are scheduled to be completed by the end of 2026, after which the Company plans to obtain manufacturing and marketing approval for the medical device promptly. Once approved, the Company will proceed with a phased rollout to begin sales in medical institutions nationwide.
(*1) The Company has positioned four key investment areas—robotics and automation, semiconductors, advanced medical devices, and environment and energy—as growth drivers, aiming to create new value and enhance its corporate value.
(*2) LIPUS is an advanced medical technology that uses external irradiation of special low-power pulsed ultrasound waves optimized for each disease site. The physical stimulation of ultrasound acts on vascular endothelial cells, enhancing the expression of eNOS (vascular endothelial nitric oxide synthase), which leads to vasodilation, and VEGF (vascular endothelial growth factor), which leads to angiogenesis, thereby improving microcirculatory disorders. For more details, please refer to the following paper:
Shindo T, and Shimokawa Ann Vasc Dis. 2020;13(2):116–125.
http://www.cardio.med.tohoku.ac.jp/pdf/13_ra.20-00010.pdf
(※3) Patients undergoing this treatment simply wear a low-power pulsed ultrasound transmitter (or a headset in the case of dementia treatment) and lie in bed. The ultrasound output used in LIPUS treatment is similar to that of diagnostic devices such as echocardiography, so patients experience no stimulation or pain, no anesthesia is required, and the treatment places minimal strain on the body. The device is compact and can be installed in medical institutions of all sizes.
Exploratory clinical trials have confirmed the safety and suggested efficacy of this treatment for dementia (early Alzheimer's disease and mild cognitive impairment (MCI)). Currently, a confirmatory clinical trial (Protocol Number: LB1101, Clinical Research Plan Number: jRCT2032230125) has reached the target number of registered cases (220) and is currently underway. Furthermore, there is strong pre-clinical evidence for the treatment of heart disease (HFpEF, myocardial infarction, severe angina, etc.), and a wide range of applications is expected in the future.
(*4) For details on the designation, please see below.
SWI "LIPUS-Brain, a medical device for the treatment of early Alzheimer's disease, has been designated as the first "Pioneering Medical Device" by the Ministry of Health, Labour and Welfare" (October 14, 2022) https://sw-innovation.com/news/info/1175/