Sound Wave Innovation Co., Ltd. (SWI, headquarters: Chuo-ku, Tokyo; CEO: Hajime Kato), which aims to socially implement LIPUS-Brain transcranial low-intensity pulsed ultrasound therapy device, a world-leading medical treatment device for dementia, has been preparing to conduct a pivotal trial to evaluate the efficacy and safety of LIPUS-Brain transcranial low-intensity pulsed ultrasound therapy device for early stage Alzheimer’s disease patients.

We are pleased to announce that written consent for the first case was obtained in September and this clinical trial has been initiated (FPI: First patient in).

For more information on the pivotal clinical trial, a dedicated page will soon be revealed on our website. The information on the pivotal clinical trial is also available on the following website.

1. clinical research submission and release system (https://jrct.niph.go.jp/search)
Clinical research protocol number:：jRCT2032230125

2． Clinical Trials.gov「ClinicalTrials.gov」（A Pivotal Study of LIPUS-Brain in Patients With Early Alzheimer’s Disease – Full Text View – ClinicalTrials.gov）
Registration number：NCT05983575

We are strongly committed to confirm the efficacy and safety of the LIPUS treatment and will continue to develop, manufacture, and socially implement the treatment device to bring this new treatment to Alzheimer’s disease patients and their families as soon as possible.