Synbio Advances AI-Based Facial Analysis for Mental Health Screening Through Australian Clinical Trial

Synbio International Inc. has executed a Master Services Agreement with CRO Services Pty Ltd, a leading Australian clinical research organization and wholly owned subsidiary of Resonance Health Ltd, to conduct a proof-of-concept clinical trial evaluating FacialDx's proprietary NIMS™ technology. The AI-powered facial analysis system is designed to identify early-stage features associated with Post-Traumatic Stress Disorder and Major Depressive Disorder, two highly prevalent mental health conditions that represent substantial challenges for healthcare systems and employers worldwide.

The trial represents a critical step toward clinical validation for technology that could fundamentally transform mental health screening practices. Current screening methods remain heavily reliant on subjective questionnaires and self-reporting, which can be influenced by stigma, recall bias, and clinician interpretation. According to National Center for Health Statistics data, mental health is discussed in approximately 150 million primary care visits annually in the United States alone, highlighting the scale of the need for improved screening tools. The technology aims to supplement clinical judgment by providing objective biological data derived from facial analysis, potentially representing the world's first objective screening test for mental health conditions.

Claudio Solitario, Chief Executive Officer of Synbio International, emphasized the strategic importance of the agreement, stating that clinical validation forms the foundation for regulatory engagement and commercial deployment. "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," Solitario noted. The technology's proactive, non-invasive, and scalable nature offers potential applications across clinical healthcare settings, corporate wellness programs, and high-risk industries where early identification could improve safety, resilience, and productivity.

Resonance Health brings extensive experience in conducting clinical studies and supporting medical technologies through regulatory pathways, including prior engagement with the U.S. Food and Drug Administration. Conducting the trial in Australia offers meaningful efficiencies in cost and timeline while maintaining internationally recognized clinical and ethical standards. Beyond initial screening applications, the technology may be used repeatedly over time to assist clinicians in objectively assessing patient progress and treatment response, addressing a long-standing industry challenge of subjective interpretation in mental health evaluation.

The trial is expected to commence in early 2026 and conclude later in the year, with data generated 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 MSA framework. If clinically validated, the technology could enable earlier identification, more consistent screening, and improved decision-support across both clinical and corporate settings, representing a substantial long-term opportunity for Synbio International.