ExaMD, an ExaWizards Group Company, Submits a Clinical Trial Notification for an AI-Powered Cognitive Function Diagnostic Support Application — Entering the Final Stages of Regulatory Approval Aiming for Early Approval within FY3/2027 Through an Innovative and Efficient Clinical Trial —
ExaMD Inc. (Minato-ku, Tokyo; Representative Director, Koji Hazama; hereafter, “ExaMD”), a group company of ExaWizards Inc. (Minato-ku, Tokyo; Representative Director, President & CEO: Makoto Haruta; hereinafter “ExaWizards”) that provides AI services in the health and medical fields, has submitted a clinical trial notification for its “AI-Powered Cognitive Function Diagnostic Support Application” (hereafter “the Application”), moving into the final stage of regulatory approval. The Application is a Software as a Medical Device (SaMD) that analyzes cognitive function from voice data collected via smartphones and other devices.
In recognition of its innovation, the Application was designated as a priority review item by the Ministry of Health, Labour and Welfare (MHLW) in February 2025*1.
☑︎Application Overview and Features
The Application is a SaMD that analyzes cognitive function from voice data acquired through smartphones and other devices.
・Simplicity: Provides a cognitive function assessment with just one minute of free conversation.
・Accuracy: Achieved 95% accuracy in clinical research with academic institutions.
・Versatility: Requires no special equipment and can be used entirely via smartphone, making it easy to introduce in medical facilities.
☑︎Background
There are 10 million people in Japan in the potential risk group for dementia*2. However, fewer than one million tests are conducted per year at medical institutions*3, indicating a significant testing shortage.
ExaMD will bridge the supply-demand gap caused by a shortage of specialists and cumbersome testing procedures to expand opportunities for early detection by providing this Application, which allows for testing “on a smartphone, in a short time, by anyone.”
In recognition of its utility and technological innovation, the Application has been granted “Priority Review Designation” by the MHLW. This provides preferential treatment during the approval review process and access to an enhanced consultation system, solidifying the path to commercialization. We are currently initiating a clinical trial to verify its efficacy and safety as the final step toward obtaining approval.
☑︎Features
In this trial, we are collaborating with regulatory authorities through the priority review designation and by optimizing the trial design to suit the characteristics of a diagnostic SaMD.
・Minimized Process: Our protocols reduce the burden on subjects by filtering the test items to the bare essentials and requiring only one hospital visit.
・Shortest Trial Duration and Low-Cost Design: Optimizing the number of cases and simplifying the process will achieve significant cost reductions and a shorter schedule when compared to conventional clinical trials.
☑︎Future Outlook
Leveraging the benefits of the priority review designation will allow us to strive for the fastest possible social implementation, with the goal of obtaining marketing and manufacturing approval within the fiscal year ending March, 2027.
Obtaining medical device approval for this app will allow ExaMD to provide a new diagnostic support tool to doctors and medical institutions and contribute to solving social issues through the early detection of dementia and mild cognitive impairment. We will leverage the expertise gained from this efficient clinical development scheme to develop and implement new digital health services based on clinical evidence.
This initiative will cultivate new markets in the medical and wellness fields. We will accelerate the adoption of diagnostic SaMD and digital health services to deliver new value to society.
*1 ExaWizards’ Wholly Owned Subsidiary, ExaMD AI-Powered Dementia Diagnosis App Using Conversational Audio Designated as a Priority Review Product under Innovative Medical Device Program (February 7, 2025).
*2 The Japan Research Institute, Ltd. “Towards an Era of 12 Million People with Dementia. What are the market possibilities in a society living together?” (Announced February 21, 2025).
*3 Estimated based on data from MHLW’s NDB Open Data (10th Edition) “Medical Practice Acts (Number of Times Billed),” etc.
ExaMD Company Profile
Company name: ExaMD Inc.
Location: 4-2-8 Shibaura, Minato-ku, Tokyo, 5F
Established: February 2024
Representative: Koji Hazama, Representative Director
Business: Planning, development, sales, and alliance of products and services using multi-modal AI technology to solve social issues related to healthcare
URL: https://examd.com/
ExaWizards Company Profile
Company name: ExaWizards Inc.
Location: 4-2-8 Shibaura, Minato-ku, Tokyo, 5F
Established: February 2016
Representative: Makoto Haruta, Representative Director, President & CEO
Business: Industrial innovation and resolution of social issues via AI service development
URL: https://exawizards.com/en/
＜Media Contact＞
ExaWizards Inc. Public Relations:publicrelations@exwzd.com