Soundwave Innovation Secures 2.65 Billion Yen in Series C Funding to Complete Clinical Trials for LIPUS-Brain, an Alzheimer's Treatment Device
Soundwave Innovation (SWI) has raised approximately 2.65 billion yen in a Series C round to complete the confirmatory clinical trial of its 'LIPUS-Brain' medical device for treating early-stage Alzheimer's disease. The funding involves domestic and international investors including Fiducia, Sumitomo Heavy Industries, and iGlobe Partners. SWI aims to complete the trial in 2026 and proceed with regulatory approval application through its partner, Sumitomo Heavy Industries.
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- 📰 Published: May 18, 2026 at 20:00
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Soundwave Innovation Co., Ltd. (Headquarters: Chiyoda-ku, Tokyo; President: Hiroaki Shimokawa; hereinafter "SWI"), which aims to create innovative, safe, and effective treatment technologies using ultrasound, has completed a Series C funding round totaling approximately 2.65 billion yen. The investment was led by the Fiducia GrowthTech Investment Limited Partnership, operated by Fiducia Co., Ltd. (Headquarters: Chuo-ku, Tokyo; Co-founders: Takumi Shibata, Tokihiko Shimizu), and included Sumitomo Heavy Industries, Ltd., international venture capitals like iGlobe Partners, business corporations, and individual investors.
The primary objective of this Series C round is the completion of the confirmatory clinical trial for the "LIPUS-Brain Transcranial Low-Intensity Pulsed Ultrasound Therapy Device," a therapeutic medical device targeting patients with early Alzheimer's disease.
### Background of Funding
SWI has been developing low-invasive treatment platform technologies using Low-Intensity Pulsed Ultrasound (LIPUS), based on the research findings of its founder and President, Hiroaki Shimokawa (Professor Emeritus at Tohoku University). The company seeks the social implementation of medical devices that bring revolutionary changes to the treatment of conditions previously considered difficult to treat, including dementia, severe angina, and arrhythmia.
LIPUS, currently positioned as SWI's main pipeline, yielded results exceeding targets in both safety and efficacy evaluation points during exploratory clinical trials aimed at evaluating safety for dementia (early Alzheimer's and Mild Cognitive Impairment (MCI)). It has received the first-ever designation as a "Pioneering Medical Device" (Sakigake) by the Ministry of Health, Labour and Welfare, and widespread expansion of target diseases is expected in the future.
The final confirmatory clinical trial (equivalent to Phase 3 for pharmaceuticals) to confirm the efficacy of LIPUS-Brain for early Alzheimer's and MCI patients, which commenced in the fall of 2023, is scheduled for completion within 2026.
Following the confirmation of efficacy in the trial, Sumitomo Heavy Industries, Ltd. (Headquarters: Shinagawa-ku, Tokyo; President: Toshiro Watanabe), which entered into a capital and business alliance with SWI in August 2025, plans to promptly perform the application procedures for manufacturing and sales approval as a dementia treatment device. After obtaining approval, both companies will collaborate to start treatment at medical institutions nationwide, striving to help patients as early as possible with this novel therapeutic device that differs from existing technologies.
### About LIPUS
Treatment utilizing LIPUS is a novel therapeutic method that differs from existing technologies. It uses low-invasive and highly safe specialized ultrasound to activate the body's inherent self-healing powers, offering a new treatment for various diseases that are difficult to treat with existing drugs or medical devices.
Activation of self-healing power by LIPUS is believed to occur by irradiating specialized low-intensity pulsed ultrasound optimized for each disease site from outside the body. The physical stimulation of the ultrasound acts on vascular endothelial cells, enhancing the expression of eNOS (endothelial Nitric Oxide Synthase) which leads to vasodilation, and VEGF (Vascular Endothelial Growth Factor) which leads to angiogenesis, thereby improving microcirculation disorders.
Patients receiving LIPUS treatment simply wear a LIPUS transmitter (a headset for dementia treatment or a chest band for cardiac treatment) and remain seated in a chair until the treatment is finished. Since the output of the ultrasound used in LIPUS treatment is comparable to that of diagnostic devices such as echocardiography, patients do not feel any stimulation or pain, and no anesthesia is required. The devices are compact and can be installed in medical institutions of any size.
*1 Results of Professor Shimokawa's exploratory clinical trial of ultrasound treatment for early Alzheimer's disease were published online in the Tohoku Journal of Experimental Medicine and press-released by Tohoku University.
### Company Overview: Soundwave Innovation Co., Ltd.
- Name: Soundwave Innovation Co., Ltd.
- Location: 1-6-1 Otemachi, Chiyoda-ku, Tokyo
- Representative: Hiroaki Shimokawa
- URL: https://sw-innovation.com/
The primary objective of this Series C round is the completion of the confirmatory clinical trial for the "LIPUS-Brain Transcranial Low-Intensity Pulsed Ultrasound Therapy Device," a therapeutic medical device targeting patients with early Alzheimer's disease.
### Background of Funding
SWI has been developing low-invasive treatment platform technologies using Low-Intensity Pulsed Ultrasound (LIPUS), based on the research findings of its founder and President, Hiroaki Shimokawa (Professor Emeritus at Tohoku University). The company seeks the social implementation of medical devices that bring revolutionary changes to the treatment of conditions previously considered difficult to treat, including dementia, severe angina, and arrhythmia.
LIPUS, currently positioned as SWI's main pipeline, yielded results exceeding targets in both safety and efficacy evaluation points during exploratory clinical trials aimed at evaluating safety for dementia (early Alzheimer's and Mild Cognitive Impairment (MCI)). It has received the first-ever designation as a "Pioneering Medical Device" (Sakigake) by the Ministry of Health, Labour and Welfare, and widespread expansion of target diseases is expected in the future.
The final confirmatory clinical trial (equivalent to Phase 3 for pharmaceuticals) to confirm the efficacy of LIPUS-Brain for early Alzheimer's and MCI patients, which commenced in the fall of 2023, is scheduled for completion within 2026.
Following the confirmation of efficacy in the trial, Sumitomo Heavy Industries, Ltd. (Headquarters: Shinagawa-ku, Tokyo; President: Toshiro Watanabe), which entered into a capital and business alliance with SWI in August 2025, plans to promptly perform the application procedures for manufacturing and sales approval as a dementia treatment device. After obtaining approval, both companies will collaborate to start treatment at medical institutions nationwide, striving to help patients as early as possible with this novel therapeutic device that differs from existing technologies.
### About LIPUS
Treatment utilizing LIPUS is a novel therapeutic method that differs from existing technologies. It uses low-invasive and highly safe specialized ultrasound to activate the body's inherent self-healing powers, offering a new treatment for various diseases that are difficult to treat with existing drugs or medical devices.
Activation of self-healing power by LIPUS is believed to occur by irradiating specialized low-intensity pulsed ultrasound optimized for each disease site from outside the body. The physical stimulation of the ultrasound acts on vascular endothelial cells, enhancing the expression of eNOS (endothelial Nitric Oxide Synthase) which leads to vasodilation, and VEGF (Vascular Endothelial Growth Factor) which leads to angiogenesis, thereby improving microcirculation disorders.
Patients receiving LIPUS treatment simply wear a LIPUS transmitter (a headset for dementia treatment or a chest band for cardiac treatment) and remain seated in a chair until the treatment is finished. Since the output of the ultrasound used in LIPUS treatment is comparable to that of diagnostic devices such as echocardiography, patients do not feel any stimulation or pain, and no anesthesia is required. The devices are compact and can be installed in medical institutions of any size.
*1 Results of Professor Shimokawa's exploratory clinical trial of ultrasound treatment for early Alzheimer's disease were published online in the Tohoku Journal of Experimental Medicine and press-released by Tohoku University.
### Company Overview: Soundwave Innovation Co., Ltd.
- Name: Soundwave Innovation Co., Ltd.
- Location: 1-6-1 Otemachi, Chiyoda-ku, Tokyo
- Representative: Hiroaki Shimokawa
- URL: https://sw-innovation.com/
FAQ
Where can patients receive this treatment?
It is currently in the confirmatory clinical trial phase at selected medical institutions in Japan. It will become available nationwide following regulatory approval, targeted after 2026.
Is the LIPUS treatment painful?
Not at all. The ultrasound output is at the same level as diagnostic echo devices, so patients feel no pain or stimulation and do not require anesthesia.
Is LIPUS effective for conditions other than Alzheimer's?
The company is also developing applications for severe angina, arrhythmia, and other conditions that benefit from improved microcirculation and angiogenesis.