ExaWizards Inc.
Notice of Submission of Clinical Trial Notification for Cognitive Function AI Diagnostic Support App (SaMD) by Subsidiary
Subsidiary ExaMD submitted a clinical trial notification for the cognitive function AI diagnostic support app to PMDA and commenced clinical trials. Target number of cases is up to 100, with a 3-month subject enrollment period planned.
Key Figures
- Target Number of Clinical Trial Cases: Up to 100 cases
- Subject Enrollment Period: 3 months
- Subsidiary ExaMD Capital Stock: 50 million yen
AI要約
Overview of Clinical Trial Initiation
ExaWizards Inc.’s wholly owned subsidiary, ExaMD Inc., announced that it has submitted a clinical trial notification to the Pharmaceuticals and Medical Devices Agency (PMDA) and commenced clinical trials in Japan for the cognitive function AI diagnostic support app (SaMD) it developed, which was designated as a priority review target under the Innovative Program Medical Device Designation System. The trial will evaluate the effectiveness of classifying subjects as 'cognitively normal' or 'MCI/dementia equivalent' based on approximately one minute of free conversation. The target number of cases is up to 100, with a planned enrollment period of 3 months. The primary endpoint is accuracy of binary classification, secondary endpoints include concordance rate with MMSE scores, and safety assessments will also be conducted.
Future Outlook
The costs associated with the clinical trial have been incorporated into the investment policy for the second half and the upward revision of operating income announced at the Q2 financial results for the fiscal year ending March 2026. There is no change to the consolidated full-year earnings forecast for the fiscal year ending March 2026. The impact on subsequent fiscal years is currently under review, and disclosures will be made promptly as necessary.
