Sound Wave Innovation and Sumitomo Heavy Industries Partner to Advance LIPUS-Brain Device for Alzheimer's Treatment
Key Insights
Sound Wave Innovation and Sumitomo Heavy Industries announced a strategic alliance to manufacture and distribute the LIPUS-Brain (search) transcranial low-intensity pulsed ultrasound (search) therapeutic device for early-stage Alzheimer's disease (search) patients.
The LIPUS-Brain (search) device demonstrated high safety and efficacy in a 2022 exploratory clinical trial and became the first "Breakthrough Medical Device" designated by Japan's PMDA in September 2022.
The companies anticipate completing pivotal clinical trials by end of 2026 with medical device approval targeted for 2027, followed by nationwide expansion to medical institutions.
Sound Wave Innovation Co., Ltd. (SWI) and Sumitomo Heavy Industries, Ltd. (SHI) have announced a strategic business alliance agreement to manufacture and distribute the "LIPUS-Brain (search) Transcranial Low-Intensity Pulsed Ultrasound (search) Therapeutic Device," marking a significant advancement in the development of innovative treatments for early-stage Alzheimer's disease (search) patients.
The partnership comes as global aging populations drive increasing demand for new treatment options that are less burdensome for patients while improving quality of life for both patients and their families. With Alzheimer's disease (search) and other forms of dementia (search) becoming pressing societal challenges worldwide, this collaboration aims to accelerate the social implementation of breakthrough medical technology.
Breakthrough Device Designation and Clinical Progress
The LIPUS-Brain (search) device has already demonstrated promising clinical potential. In a physician-led exploratory clinical trial concluded in 2022, the device showed high safety and results suggesting high efficacy. These encouraging outcomes led to LIPUS-Brain receiving designation as the first "Breakthrough Medical Device" by the Japanese Ministry of Health, Labour and Welfare (search) (PMDA) on September 30, 2022.
Following this regulatory milestone, SWI initiated a pivotal clinical trial in October 2023. The companies anticipate completion of this pivotal trial by the end of 2026, with the goal of achieving medical device approval in 2027.
Strategic Alliance Structure
Under the terms of the agreement, Sound Wave Innovation will continue promoting the pivotal clinical trials for LIPUS-Brain (search) and license the intellectual property related to the device. Sumitomo Heavy Industries will provide funding for the trial through a strategic equity investment in Sound Wave Innovation and will be responsible for manufacturing and distribution of the device.
The collaboration leverages Sumitomo Heavy Industries' 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 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.
Technology Platform and Future Applications
Sound Wave Innovation was founded by Dr. Hiroaki Shimokawa (MD, PhD; Emeritus Professor, Tohoku University) and has developed a minimally invasive treatment platform technology using Low-Intensity Pulsed Ultrasound (search) (LIPUS). The company's mission focuses on bringing innovative medical devices to society that can revolutionize treatments for intractable diseases, including dementia (search), severe angina (search), and chronic kidney disease (search).
The partnership represents both companies' commitment to providing new medical options for Alzheimer's disease (search) treatment, contributing to improved patient quality of life, and accelerating the early practical application and widespread use of the LIPUS-Brain (search) therapeutic device.
Market Implementation Timeline
Following anticipated approval in 2027, both companies plan to collaborate on expanding treatment availability to medical institutions nationwide. This timeline positions the LIPUS-Brain (search) device to potentially become one of the first transcranial ultrasound therapies approved for Alzheimer's disease (search) treatment.
Sound Wave Innovation envisions LIPUS technology evolving into an excellent modality for numerous indications related to microcirculatory impairment (search), while Sumitomo Heavy Industries continues advancing its 2030 vision of being "a company that supports a rich society with core technologies and realizes CSV (Creating Shared Value)."