Sound Wave Innovation Co., Ltd. (SWI) and Sumitomo Heavy Industries, Ltd. (SHI) today announced the signing of a business alliance agreement for the manufacturing and distribution of the “LIPUS-Brain Transcranial Low-Intensity Pulsed Ultrasound Therapeutic Device”. This strategic partnership aims to jointly promote the social implementation of this innovative medical device, targeting early-stage Alzheimer’s disease patients.

1. Background and Purpose of the Alliance
With the global increase in aging populations, Alzheimer’s disease and other forms of dementia have become pressing societal challenges. There is a strong demand for new treatment options that are less burdensome for patients and contribute to improving the Quality of Life (QOL) for both patients and their families.
Sound Wave Innovation, founded by Dr. Hiroaki Shimokawa (MD, PhD; Emeritus Professor, Tohoku University), has developed a minimally invasive treatment platform technology using Low-Intensity Pulsed Ultrasound (LIPUS). SWI’s mission is to bring innovative medical devices to society that can revolutionize treatments for intractable diseases, such as dementia, severe angina, and chronic kidney disease.
Notably, LIPUS-Brain demonstrated high safety and showed results suggesting high efficacy in a physician-led exploratory clinical trial concluded in 2022. Following these promising results, LIPUS-Brain was designated as the first “Breakthrough Medical Device” by the Japanese Ministry of Health, Labour and Welfare (PMDA) on September 30, 2022. Subsequently, SWI began a pivotal clinical trial in October 2023.

2. Synergy and Collaborative Goals
Sumitomo Heavy Industries possesses extensive experience and knowledge in medical device manufacturing, making it an optimal partner to accelerate the social implementation of Sound Wave Innovation’s LIPUS technology. SHI has also positioned the “Advanced Medical Device Field” as one of its key investment areas within its “Medium-Term Management Plan 2026”, aiming to foster it as a growth driver.
Through this alliance, both companies are committed to:
• Providing new medical options for Alzheimer’s disease treatment.
• Contributing to the improvement of patient QOL.
• Accelerating the early practical application and widespread use of the LIPUS-Brain therapeutic device.
• Solving the social challenge of improving QOL for patients and their families.

3.Alliance Overview and Future Plans
Under the terms of the agreement:
• Sound Wave Innovation will continue to promote the pivotal clinical trials for LIPUS-Brain and license the intellectual property related to the device.
• Sumitomo Heavy industries will fund the trial through a strategic equity investment in Sound Wave Innovation.
• Sumitomo Heavy Industries will be responsible for the manufacturing and distribution of the device.
The companies anticipate the completion of the pivotal clinical trial by the end of 2026, with the goal of achieving medical device approval in 2027. Following approval, both companies will collaborate to expand treatment availability to medical institutions nationwide.

4.Future Outlook
Sumitomo Heavy Industries is advancing its “Medium-Term Management Plan 2026” and its 2030 vision of being “a company that supports a rich society with core technologies and realizes CSV (Creating Shared Value),” with a focus on concentrated investment in the “Advanced Medical Device Field”.
Sound Wave Innovation remains committed to the social implementation of its minimally invasive treatment platform technology, envisioning LIPUS technology evolving into an excellent modality for numerous indications related to microcirculatory impairment.
This partnership underscores both companies’ dedication to accelerating business growth and maximizing sustainable corporate value while addressing critical societal health needs.

【About Sound Wave Innovation Co., Ltd.】
Sound Wave Innovation Co., Ltd. is a company dedicated to the research, development, licensing, manufacturing, and sales of Low-Intensity Pulsed Ultrasound (LIPUS) and Shockwave Ablation Catheter System (SWCS) technologies. Its corporate mission is the social implementation of minimally invasive treatment platform technologies with sound waves.

【About Sumitomo Heavy Industries, Ltd.】
Sumitomo Heavy Industries, Ltd. is a comprehensive heavy machinery manufacturer engaged in the manufacturing and sales of various types of machinery, equipment, and plants. Its “Medium-Term Management Plan 2026” identifies four key investment areas; Robotics/Automation, Semiconductors, Advanced Medical Devices, and Environment/Energy.

Contact :
Sound Wave Innovation Co., Ltd.
mail：info@sw-innovation.com