ExaWizards Group's ExaMD Begins Clinical Development for Japan's First*1 "Home-Use" Conversational Voice Dementia AI Diagnostic Support App (SaMD)

ExaMD Inc. (Headquarters: Minato-ku, Tokyo; Representative Director: Yasushi Hama, hereinafter ExaMD), a group company of ExaWizards Inc. (Minato-ku, Tokyo; President and CEO: Makoto Haruta), has commenced clinical development for its Conversational Voice Dementia AI Diagnostic Support App (hereinafter "the Product"), which evaluates cognitive function using proprietary AI from free conversation voice, for home use under a doctor's prescription. The product, currently in clinical trials*2 as a Software as a Medical Device (SaMD) for diagnostic support, would be the first in Japan*1 if approved for home use. The company aims for early approval of the Product, including for home use.

☑ Background

MCI (Mild Cognitive Impairment), the stage before dementia, is not yet dementia, and it is possible to maintain or improve cognitive function through appropriate intervention while continuing daily life. Noticing MCI at this stage is a critical turning point that significantly impacts one's future life. Early detection allows for the suppression of progression not only through pharmacotherapy but also non-pharmacological treatments. Furthermore, as it is not yet dementia, the individual's wishes can be widely reflected, including in various contractual matters.

However, in Japan, most people are not aware they are in the MCI stage. While the number of people with dementia and MCI combined is estimated to be around 10 million*3 in Japan, cognitive function tests necessary for their detection are performed only about 900,000 times*4 annually. With a low detection rate of MCI at around 6-15%*5, many cases are not detected and are only discovered after progression.

This is due to the burden of hospital visits and psychological stress of testing for patients, as well as the significant burden on medical institutions to conduct cognitive function tests. Moreover, existing simple tests (e.g., MMSE) have significant variability in sensitivity for MCI, with some reports indicating a detection rate as low as 20%*6, making it easy to miss early changes. Although cognitive function is generally measured at medical institutions, measuring it in a familiar environment is reported to be useful for capturing true cognitive function more naturally (Sliwinski et al., 2016*7), indicating numerous challenges with current measurement methods.

☑ Product Overview and Features

The Product is expected to reduce the psychological burden on patients and the clinical burden on healthcare professionals through the simple method of "1 minute of free conversation." Furthermore, by realizing functions that can be completed on a terminal (edge AI), it can be used at home while protecting privacy, such as personal information.

In February 2025, the Product was designated as a priority review item under the Ministry of Health, Labour and Welfare's "Designation System for Innovative Program Medical Devices" and is currently undergoing clinical trials, the final stage before seeking approval. ExaMD will accelerate clinical development for expanded use at home and aims for the approval and sale of this new SaMD that allows for easy cognitive function measurement at home.

Through this Product, ExaMD aims to contribute to solving the social issue of dementia prevention, striving for a society where cognitive function measurement is as commonplace as blood pressure measurement.

*1 Self-researched as of June 2026, for voice AI SaMD (Software as a Medical Device) for diagnostic support, as a case of development considering home use.

*2 Completed enrollment of the first case in clinical trials for the cognitive function AI diagnostic support app (May 18, 2026).

*3 Estimates of the number of dementia and MCI patients are based on research such as the Ministry of Health, Labour and Welfare's Grant for Scientific Research on Health and Labour Sciences "Research on Future Projections of the Elderly Population with Dementia in Japan."

*4 Estimated based on Ministry of Health, Labour and Welfare NDB Open Data (10th edition) "Medical Practice (Number of Claims)", etc.

*5 Proportion detected at the MCI (Mild Cognitive Impairment) stage. Based on overseas epidemiological studies (Borson et al. / Savva et al., etc.).

*6 The detection sensitivity of existing simple tests such as MMSE for MCI varies greatly depending on the cutoff value and target population. Nasreddine et al. (2005) reported an MCI detection sensitivity of 18% (cutoff 26) (Breton et al., Int J Geriatr Psychiatry. 2019;34(2):233-42 / Mitchell AJ, J Psychiatr Res. 2009;43(4):411-31, etc.).

*7 Sliwinski MJ, Mogle JA, Hyun J, Munoz E, Smyth JM, Lipton RB. Reliability and Validity of Ambulatory Cognitive Assessments. Assessment. 2018;25(1):14-30 (Epub 2016 Apr 15). doi:10.1177/1073191116643164. A study examining the reliability and validity of repeated cognitive function assessments in daily environments (ecological momentary assessment).

【ExaMD Company Profile】 Company Name: ExaMD Inc. Location: Sumitomo Fudosan Shibaura Building 5F, 4-2-8 Shibaura, Minato-ku, Tokyo Established: February 2024 Representative: Yasushi Hama, Representative Director Business Activities: Planning, development, sales, and alliances of products and services using multimodal AI technology (including program medical devices) aimed at solving social issues in the health and medical fields. URL: https://examd.com/

【ExaWizards Company Profile】 Company Name: ExaWizards Inc. Location: Sumitomo Fudosan Shibaura Building 5F, 4-2-8 Shibaura, Minato-ku, Tokyo Established: February 2016 Representative: Makoto Haruta, President and CEO Business Activities: Industrial innovation and resolution of social issues through the development of services utilizing AI. URL: https://exawizards.com/