Synbio International Inc. has executed a Master Services Agreement with CRO Services Pty Ltd, a leading Australian clinical research organization and 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 through non-invasive screening.
The trial represents a critical step toward clinical validation for the technology, which has shown promising performance in internal non-clinical testing. Conducting the study in Australia offers meaningful efficiencies in cost and timeline while maintaining internationally recognized clinical and ethical standards. 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.
Mental health conditions represent one of the most common and costly challenges facing healthcare systems and employers. In the United States alone, mental health is discussed or assessed in an estimated 150 million primary care visits annually, excluding specialty visits and emergency care. Despite this scale, current mental health screening remains heavily reliant on subjective questionnaires and self-reporting, which can be influenced by stigma, recall bias, and clinician interpretation.
The NIMS technology is designed to supplement clinical judgment by providing objective biological data derived from facial analysis. If clinically validated, it may represent the world's first objective screening test for a mental health condition, enabling earlier identification, more consistent screening, and improved decision-support across both clinical and corporate settings. The technology is proactive, non-invasive, rapid, and scalable, with potential applications across clinical healthcare settings, corporate wellness programs, and high-risk industries where early identification may improve safety, resilience, and productivity.
Claudio Solitario, Chief Executive Officer of Synbio International, emphasized the strategic importance of clinical validation as the foundation for regulatory engagement and commercial deployment. Major Depressive Disorder is now one of the leading causes of disability among Americans aged 15 to 44, highlighting the growing need for objective, scalable mental health screening tools. The technology's focus on biological data rather than subjective interpretation addresses a long-standing industry challenge.
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. Beyond initial screening, the technology may be used repeatedly over time to assist clinicians in objectively assessing patient progress and treatment response. The agreement with CRO Services represents a significant milestone in advancing AI diagnostics for mental health, potentially transforming how these prevalent conditions are identified and managed across healthcare and workplace environments.
