Announced details
Early detection of dementia and mild cognitive impairment; health and medical care
Assessment possible through approximately 1 minute of free conversation; approximately 95% diagnostic accuracy confirmed in an exploratory study; protocol requiring 1 visit
Enrollment of the first participant in the clinical trial completed
株式会社ExaMD is a group company of ExaWizards Inc.
Designated by the Ministry of Health, Labour and Welfare as a “priority review product”
Ministry of Health, Labour and Welfare
Sumitomo Fudosan First Building, 5th Floor, 4-2-8 Shibaura, Minato-ku, Tokyo
The impact on results for the fiscal year ending March 2027 is expected to be immaterial.
The company does not address Contract Value / Offering price.
The Japan Research Institute, Limited, “Entering an Era of 12 Million People with Dementia: What Are the Market Opportunities in a Society of Coexistence?”; Ministry of Health, Labour and Welfare NDB Open Data (10th edition), “Medical Services (Number of Claims),” among other sources
| Item | Details |
|---|---|
| Names of Products / Services Covered | Cognitive function AI-assisted diagnostic app (software as a medical device (SaMD)) |
| Relationship with the Company | 株式会社ExaMD is a group company of ExaWizards Inc. |
| Launch date | Within FY2026 (planned: obtaining marketing approval and launching sales) |
| Applicable area | Early detection of dementia and mild cognitive impairment; health and medical care |
| Award/certification name | Designated by the Ministry of Health, Labour and Welfare as a “priority review product” |
| Awarding / certifying body | Ministry of Health, Labour and Welfare |
| Location | Sumitomo Fudosan First Building, 5th Floor, 4-2-8 Shibaura, Minato-ku, Tokyo |
| Quantitative Effects | Assessment possible through approximately 1 minute of free conversation; approximately 95% diagnostic accuracy confirmed in an exploratory study; protocol requiring 1 visit |
| Usage history | Enrollment of the first participant in the clinical trial completed |
| Impact on Business Performance | The impact on results for the fiscal year ending March 2027 is expected to be immaterial. |
| Source | The Japan Research Institute, Limited, “Entering an Era of 12 Million People with Dementia: What Are the Market Opportunities in a Society of Coexistence?”; Ministry of Health, Labour and Welfare NDB Open Data (10th edition), “Medical Services (Number of Claims),” among other sources |
Items this document does not state (7)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.To leverage the benefits of the product's designation by the Ministry of Health, Labour and Welfare as a priority review product and accelerate the commercialization of a product for the early detection of dementia and mild cognitive impairment, as well as the acquisition of approval and the launch of sales.