LIPUS – Dementia

Based on the idea that LIPUS treatment that improves microcirculatory insufficiency could also be effective for dementia, the basic research ( by using two types of mouse models) was started.
The research project was adopted by AMED Innovative Medical Seed.
A paper on the efficacy and safety in the 2 mouse models was published.
Investigator-initiated clinical trial Part 1 for mild dementia was conducted (short-term safety, 5 cases). Safety was certified by the Efficasy and Safety Judgment Committee.
The physician-led clinical trial Part 2 has been conducted.(efficacy / long-term safety, 22 cases).
LIPUS-Brain, a Medical Device for the Treatment of Early Alzheimer’s Disease, was designated as an Eligible Product under the Breakthrough Medical Device Designation Program of the Ministry of Health, Labor and Welfare.
2023 summer
Pivotal clinical trial of LIPUS-Brain for early Alzheimer’s disease is planned.

LIPUS – Angina

Pro. Shimokawa came up with the idea of angina treatment using low-intensity shock waves when he listend to a presentation of an Italy group that “Irradiation of cultured endothelial cells with low-intensity shock waves enhances nitric oxide synthase (eNOs) activity at a specific number of irradiations” at the 1st Annual Scientific Meeting of the Japanese Society of NO Society held in 2001. Then he started the basic research with his group.
After several experiments, he discovered that a low-intensity shock wave, which is about one-tenth to the current lithotripsy treatment, regenerates blood vessels most efficiently. Then Prof. Simokawa group co-developed a shock wave treatment device for heart disease with a Swiss medical device company.
Primary (open study) and secondary (placebo-controlled, double-blind study) clinical studies were done for severe angina.
Low-intensity shock wave extracorporeal therapy for severe angina was approved in Japan as advanced medical care (currently advanced medical care B).
The development of angiogenesis technology using less invasive ultrasound was started, and discovered that 32-wave low-intensity pulsed ultrasound (LIPUS) has almost the same effect as the low-power shock wave, and a patent was filed in 2009 (granted; 2014).
The investigator-initiated clinical trial for severe angina using LIPUS was started at 10 hospitals nationwide, including Tohoku University Hospital.
Mechanism of action of LIPUS was elucidated in detail at molecular level and a paper was published.
Regarding severe angina clinical trial, LPI was done (62 patients in total) -Follow-up will be completed in December 2020 (AMED Seed C).

Shock wave ablation catheter system

Based on the idea that shock waves could also be effective in treating intractable arrhythmias, the development of shock wave ablation catheter system was started.
The development program was adopted as JST A-STEP project, and Shock Wave Medical (currently dormant) was established at the end.
AMED Research Fund (Translational Research Seed B) supported the development.
AMED Research Fund (Medical Device Development Promotion Research Project) supported the development.
So far, three papers on efficacy and safety in the pig model have been published.
AMED Research Fund (Translational Research Pre-C Project) supported the development.
Shock Wave Ablation Catheter System (SWCS), a medical device for treating arrhythmia, was granted a patent in Japan. Patents granted in the U.S., EU, and Japan.