Sound Wave Innovation Co., Ltd. (Headquarters: Chiyoda-ku, Tokyo; President, CEO and CMO: Hiroaki Shimokawa; hereinafter “SWI”), which aims to create safe and effective innovative treatment technologies using ultrasound, announced today that it has completed a Series C financing round raising a total of approximately 2.65 billion JPY.
This funding was secured through a third-party allotment of new shares to complete the pivotal clinical trial for the “LIPUS-Brain Transcranial Low-Intensity Pulsed Ultrasound Therapeutic Device,” targeting early-stage Alzheimer’s disease patients.
The investment was led by Fiducia GrowthTech Investment Limited Partnership, managed by Fiducia Inc. (Headquarters: Chuo-ku, Tokyo; Co-founders: Takumi Shibata, Tokihiko Shimizu), and Sumitomo Heavy Industries, Ltd., along with iGlobe Partners and other domestic and international venture capital firms, medical companies, and individual investors.

■Background of the Financing
Based on the research results of Dr. Hiroaki Shimokawa (Founder, Emeritus Professor of Tohoku University, and current President, CEO and CMO of SWI), SWI has developed a minimally invasive treatment platform technology using Low-Intensity Pulsed Ultrasound (LIPUS).
With this technology, SWI aims to bring innovative medical devices to society that can revolutionize treatments for intractable diseases, such as dementia, severe angina, and arrhythmias.

LIPUS, currently positioned as SWI’s main pipeline, achieved results exceeding targets for both safety and efficacy endpoints in an exploratory clinical trial aimed at evaluating safety for dementia (early-stage Alzheimer’s disease and mild cognitive impairment (MCI)) (*1). Consequently, it was designated as the first “Breakthrough Medical Device” by the Japanese Ministry of Health, Labour and Welfare, and a widespread expansion of target indications is expected in the future.
Subsequently, the final pivotal clinical trial (equivalent to Phase 3 for pharmaceuticals) to confirm the efficacy of “LIPUS-Brain” in patients with early-stage Alzheimer’s disease and MCI, which began in the fall of 2023, is scheduled to be completed by the end of 2026.
Following the confirmation of efficacy in the pivotal clinical trial, Sumitomo Heavy Industries, Ltd. (Headquarters: Shinagawa-ku, Tokyo; President and CEO: Toshiro Watanabe), with which SWI entered into a business alliance in August 2025, plans to promptly proceed with the approval application procedures for the manufacturing and distribution of the medical device for dementia treatment. After obtaining approval, both companies will collaborate to expand treatment availability to medical institutions nationwide, committing to making this entirely new therapeutic device distinct from existing technologies available to patients as soon as possible.

■About LIPUS
Treatment utilizing LIPUS is a highly safe, minimally invasive procedure that uses special ultrasound to activate the human body’s inherent self-healing abilities. It has the potential to become an entirely new therapeutic technology, offering a novel approach for various diseases that are difficult to treat with current pharmaceuticals or medical devices.
The activation of self-healing capabilities by LIPUS is believed to occur by externally applying special low-intensity pulsed ultrasound optimized for each disease site. The physical stimulation of the ultrasound acts on vascular endothelial cells, upregulating the expression of eNOS (endothelial nitric oxide synthase), which leads to vasodilation, and VEGF (vascular endothelial growth factor), which promotes angiogenesis, thereby improving microcirculatory impairment.
Patients undergoing LIPUS treatment simply sit in a chair wearing a LIPUS transmitter (a headset for dementia treatment, or a chest band for cardiac disease treatment) until the session is complete.
The ultrasound intensity used in LIPUS treatment is comparable to that of diagnostic devices like echocardiography, meaning patients experience no stimulation or pain, and no anesthesia is required. The device is compact and can be installed in medical institutions of any size.

*1 The results of Dr. Shimokawa’s exploratory clinical trial on LIPUS therapy for early-stage Alzheimer’s disease were published online in the Tohoku Journal of Experimental Medicine, and a press release was issued by Tohoku University.
https://sw-innovation.com/news/paper/1132/

【About Sound Wave Innovation Co., Ltd.】
Company Name: Sound Wave Innovation Co., Ltd.
Location: 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Representative: Hiroaki Shimokawa
URL: https://sw-innovation.com/en/