Synbio International Inc. has executed a Master Services Agreement with CRO Services Pty Ltd, a leading Australian clinical research organization, to conduct a proof-of-concept clinical trial evaluating its AI-powered facial analysis screening technology for mental health disorders. The trial will assess the NIMS™ technology's ability to identify early-stage features associated with Post-Traumatic Stress Disorder and Major Depressive Disorder through non-invasive facial analysis.
The study represents a critical step toward clinical validation, which is essential for potential regulatory engagement and commercial adoption. While internal non-clinical testing has shown promising results, this trial will evaluate the technology's accuracy, reliability, and clinical utility under real-world conditions. Conducting the trial in Australia offers efficiencies in cost and timeline while maintaining internationally recognized clinical standards. Resonance Health, the parent company of CRO Services, brings extensive experience in clinical studies and regulatory pathways, including prior engagement with the U.S. Food and Drug Administration.
Mental health conditions represent one of the most significant challenges facing healthcare systems, with approximately 150 million primary care visits in the United States annually involving mental health discussion according to National Center for Health Statistics data available at https://www.cdc.gov/nchs/. Current screening methods rely heavily on subjective questionnaires and self-reporting, which can be influenced by stigma, recall bias, and clinician interpretation. The technology aims to supplement clinical judgment by providing objective biological data derived from facial analysis.
If clinically validated, the technology could become the world's first objective screening test for mental health conditions, enabling earlier identification and more consistent screening across clinical and corporate settings. Beyond initial screening, the technology may assist clinicians in objectively assessing patient progress and treatment response over time. The proactive, non-invasive, and scalable nature of the technology makes it suitable for various applications including primary care, behavioral health settings, corporate wellness programs, and high-risk industries where early identification could improve safety and productivity.
"Clinical validation is the foundation for regulatory engagement and commercial deployment," said Claudio Solitario, Chief Executive Officer of Synbio International. "The need for objective, scalable mental health screening tools has never been greater - Major Depressive Disorder is now one of the leading causes of disability among Americans aged 15 to 44." The technology addresses a long-standing industry challenge by relying on patients' biological data rather than solely subjective interpretation.
The trial is expected to commence in early 2026 and conclude later in the year, with data intended to inform future regulatory submissions and guide commercialization strategy. Final execution remains subject to completion of the Statement of Work, cost schedules, and a Clinical Trial Research Agreement under the Master Services Agreement framework. This development represents a significant advancement toward addressing the substantial market need for objective mental health screening tools that can integrate into existing clinical workflows.
