ExaMD, an ExaWizards Group Company, Completes First Patient Registration in Clinical Trial for AI-Driven Cognitive Diagnostic Support App

ExaMD Inc. (Minato-ku, Tokyo; Representative Director: Yasuyuki Hama; hereinafter 'ExaMD'), a group company of ExaWizards Inc. (Minato-ku, Tokyo; Representative Director & President: Makoto Haruta) that develops and provides AI services specialized in the health and medical fields, announces the completion of the First Patient In (FPI) registration for a clinical trial validating the efficacy and safety of its 'Cognitive Function AI Diagnostic Support App' (hereinafter 'the product') currently under development. The product is a Software as a Medical Device (SaMD) that analyzes cognitive function from 'voice' acquired through smartphones and other devices. Having been designated as a 'Priority Review Item'*1 by the Ministry of Health, Labour and Welfare in February 2025, the start of this clinical trial marks the rapid advancement of the final stage process toward obtaining approval.

Background and Significance of This Clinical Trial
While it is estimated that there are approximately 10 million people in the potential dementia risk group in Japan*2, the actual number of tests remains under 1 million per year*3, making severe testing shortage a significant social issue.
Through this clinical trial, ExaMD aims to commercialize the product, which possesses the following features:
- Simplicity: Cognitive function can be assessed simply by engaging in 'free conversation' for about 1 minute.
- High Accuracy: Demonstrated a diagnostic accuracy of approximately 95% in clinical research (exploratory trials) with academia.
- Versatility: Easy to introduce into facilities as it is completed on devices like smartphones without the need for dedicated equipment.

Early Implementation through Efficient Clinical Trial Design
In addition to collaboration with government bodies via the priority review designation, this clinical trial adopts the following optimized design:
- Reduction of patient burden: Adopts a protocol that minimizes test items and requires only one clinic visit.
- Balance of speed and cost: Realizes significant timeline reduction and cost savings compared to traditional clinical trials through process simplification.

Future Outlook
ExaMD aims to maximize the benefits of the priority review designation to obtain manufacturing and marketing approval and commence sales within FY2026.
Through the social implementation of this product, the company will contribute to the early detection of dementia and mild cognitive impairment, while promoting the formation of new markets spanning the medical to health domains. Furthermore, utilizing the know-how of the efficient clinical development scheme established this time, they will accelerate the rapid development of next-generation digital health services.

*1 ExaMD's AI medical device (SaMD) for diagnosing dementia via free conversation voice approved for designation policy as a Priority Review item under the Innovative Software as a Medical Device Designation System (dated February 7, 2025)
*2 The Japan Research Institute, Limited, 'Toward the Era of 12 Million Dementia Patients. What is the Market Potential in an Inclusive Society?' (announced February 21, 2025)
*3 Estimated based on the Ministry of Health, Labour and Welfare NDB Open Data (10th) 'Medical Practices (Number of Calculations)', etc.