The “LIPUS-Brain transcranial low intensity pulsed ultrasound therapy device (LIPUS-Brain)” for the treatment of patients with early Alzheimer’s disease, which has been developed by Sound Wave Innovation Co., Ltd. (SWI, Chuo-ku, Tokyo; President & CEO Kentaro Shiratsuchi) and a research group (Tohoku University) led by Professor Hiroaki Shimokawa, founder and chairman of the board of SWI, was accepted for designation by the Ministry of Health, Labor and Welfare (MHLW) as an eligible product under the “Breakthrough Medical Devices, In Vitro Diagnostic Products and Regenerative Medicine Products Designation System (the “Breakthrough Medical Devices Designation Program”) as of September 5, 2022.

The “LIPUS-Brain” is the first medical device to be designated as an eligible product under the “Breakthrough Medical Device Designation Program” since the system legislated in September 2020.

The “Breakthrough Medical Device Designation Program” is a system under which MHLW designates products that meet the following conditions for early commercialization, based on the acceptance of the Pharmaceutical Affairs and Food Sanitation Council, including (1) the product is a pioneering medical device, (2) the disease is serious, (3) the product has extremely high efficacy for the disease, and (4) willingness and system for early development and submission for approval in Japan ahead of the rest of the world.

This program aims to provide patients with the world’s most advanced medical devices at the earliest possible stage and allows innovative medical devices that meet certain requirements to be designated as breakthrough medical devices at a relatively early stage of development and receive preferential treatment, such as priority in consultation and review for regulatory approval. The new designation will enable the company to receive preferential treatment in the consultation and review process for drug approvals.

The “LIPUS-Brain”, which has been designated as an eligible product, is a device that uses low-intensity pulsed ultrasound (LIPUS) irradiation to induce the formation of a caveolin-1/β1-integrin complex in endothelial cells of blood vessels. As a result, it reduces amyloid-β accumulation, suppresses microglial activity, and enhances angiogenesis and remyelination downstream, thereby suppressing cognitive decline through complex mechanisms.

SWI aims to start a pivotal clinical trial of the “LPUS-Brain” within fiscal year 2022, and to submit for application file within fiscal year 2025. Taking the opportunity of this designation as an eligible product under the “Breakthrough Medical Device Designation Program”, the company will further accelerate the development of the “LIPUS-Brain” and strive to provide medical devices for the treatment of Alzheimer’s disease in Japan and abroad as soon as possible.

Breakthrough Medical Device Designation Program
The ” Breakthrough Medical Device Designation Program” has been implemented on a trial basis as the ” Breakthrough Review and Designation Program” since 2015 to promote the development of innovative pharmaceuticals, medical devices, and regenerative medicine products for early commercialization in Japan, and was made into a law as the ” Breakthrough Medical Device Designation Program” in September 2020.

Medical devices, in vitro diagnostic products, and regenerative medical products to be designated must meet all of the following four requirements.

(1) Pioneer in treatment or diagnosis
In principle, the medical device must have a new principle, in vitro diagnostic product must have a new principle or new measurement item, and regenerative medical product must have a new mechanism of action.

(2) Severity of the target disease
The disease must fall into one of the following categories.

• – Serious disease with life-threatening consequences
• – Disease with no curative treatment and with ongoing symptoms (difficulty in living in society)

(3) Extremely high efficacy or safety related to the target disease
No existing treatment or diagnostic method, significant improvement in efficacy compared to existing treatment or diagnostic methods, or significant improvement in safety is expected. However, as a significant improvement in efficacy or safety is expected, at least efficacy and safety in humans must have been suggested in exploratory clinical trials, etc., whether in Japan or overseas.

(4) Willingness and system for early development and submission for approval in Japan ahead of the rest of the world
The applicant must have intention and system for early development and submission of an application in Japan ahead of the rest of the world (countries that have an approval system at the same level as that of Japan) or at the same time as the application is submitted in Japan. The applicant must have a system that enables it to apply for approval using the pioneering comprehensive evaluation consultation conducted by the Pharmaceuticals and Medical Devices Agency (PMDA) and a system that can respond to a prompt approval review.

Medical devices for which efficacy can be expected to a certain degree based on the results of non-clinical studies, etc., and for which clinical trials are to be conducted in Japan and other countries are preferred. In addition, when applying for approval for a medical device that requires a companion diagnostic reagent, etc. for use, the applicant must have a system (including a system for collaboration with other companies) that enables it to apply for approval for said diagnostic reagent, etc. at the same time. The applicant must have a system (including a system for collaboration with other companies) to apply for approval for such diagnostics, etc. in parallel.

Pioneering Medical Devices, In Vitro Diagnostic Products, and Regenerative Medicine Products Designation System
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/000013196.html

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