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 trial, scheduled to commence in early 2026, will assess the accuracy, reliability, and clinical utility of this AI-powered facial analysis medical health technology in real-world clinical conditions.
The technology represents a significant advancement in mental health screening, designed to identify early-stage features associated with Post-Traumatic Stress Disorder and Major Depressive Disorder. These conditions represent substantial healthcare challenges, with Major Depressive Disorder now ranking as one of the leading causes of disability among Americans aged 15 to 44. The current screening landscape relies heavily on subjective questionnaires and self-reporting, which can be influenced by stigma, recall bias, and clinician interpretation.
Claudio Solitario, Chief Executive Officer of Synbio International, emphasized the strategic importance of this development, stating that clinical validation serves as the foundation for regulatory engagement and commercial deployment. The technology aims to supplement clinical judgment by providing objective biological data derived from facial analysis, addressing what Solitario described as "a long-standing industry challenge." If clinically validated, this could represent the world's first objective screening test for mental health conditions.
The trial's location 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. Data generated from the study is intended to inform future regulatory submissions and guide commercialization strategy across both healthcare and corporate markets.
Beyond initial screening applications, the technology may be used repeatedly over time to assist clinicians in objectively assessing patient progress and treatment response. Its proactive, non-invasive, rapid, and scalable nature creates potential applications across clinical healthcare settings including primary care, behavioral health, and psychiatry, as well as corporate wellness and occupational health programs. High-risk industries where early identification may improve safety, resilience, and productivity represent additional market opportunities.
The scale of the mental health challenge underscores the potential impact of this technology. In the United States alone, mental health is discussed or assessed in an estimated 150 million primary care visits annually, excluding specialty visits, emergency care, and other healthcare encounters. This represents approximately 15.9% of primary care visits based on national data from the National Center for Health Statistics - Ambulatory Care Use and Physician Office Visits available at https://www.cdc.gov/nchs/fastats/physician-visits.htm.
Final execution of the trial remains subject to completion of the Statement of Work, cost schedules, and a Clinical Trial Research Agreement under the Master Services Agreement framework. The technology development represents Synbio's focus on bridging the gap between wellness and medicine through clinically validated AI-driven medical diagnostics, with the company maintaining clinical and regulatory leadership throughout the trial process pursuant to its agreement with FacialDx Inc., the developer of the underlying facial analysis technology.
