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 FacialDx's proprietary NIMS™ technology. The AI-powered facial analysis software 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 technology that could address significant gaps in current mental health screening practices. Mental health conditions are among the most common and costly challenges facing healthcare systems, with approximately 150 million primary care visits in the United States annually involving mental health discussions according to National Center for Health Statistics data available at https://www.cdc.gov/nchs/. Despite this scale, current screening relies heavily on subjective questionnaires and self-reporting that can be influenced by stigma and recall bias.
"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 is designed to supplement clinical judgment by providing objective biological data derived from facial analysis. If validated, it 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.
Resonance Health, the parent company of CRO Services, 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 efficiencies in cost and timeline while maintaining internationally recognized clinical and ethical standards.
The proactive, non-invasive technology has potential applications across clinical healthcare settings including primary care, behavioral health, and psychiatry, as well as corporate wellness programs and high-risk industries where early identification could improve safety and productivity. The trial is expected to commence in early 2026 and conclude later in the year, with data intended to inform future regulatory submissions and 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. The trial will be conducted under Synbio's clinical and regulatory leadership pursuant to its agreement with FacialDx Inc., the developer of the underlying facial analysis technology. More information about the company is available at https://www.synbiointl.com.
