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. This AI-powered facial analysis system identifies early-stage features associated with Post-Traumatic Stress Disorder and Major Depressive Disorder, two highly prevalent and costly mental health conditions.
The trial represents a critical step toward clinical validation, which is essential for potential regulatory engagement and commercial adoption. While internal non-clinical testing has demonstrated promising performance, this study will assess the technology's accuracy, reliability, and clinical utility in real-world conditions. 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 meaningful efficiencies in cost and timeline while maintaining internationally recognized clinical and ethical standards.
This development addresses significant limitations in current mental health screening practices, which remain heavily reliant on subjective questionnaires and self-reporting that can be influenced by stigma, recall bias, and clinician interpretation. 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 others. The 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.
Beyond initial screening, the technology may be used repeatedly over time to assist clinicians in objectively assessing patient progress and treatment response. The proactive, non-invasive, rapid, and scalable technology has 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 potential markets.
Claudio Solitario, Chief Executive Officer of Synbio International, emphasized the strategic importance of this agreement, stating that clinical validation is 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 said. "Our focus is on empowering clinicians with an affordable, easy-to-use tool that enhances existing workflows. Importantly, NIMS is based on the patient's own biological data and does not rely solely on subjective interpretation, addressing a long-standing industry challenge."
The trial is expected to commence in early 2026 and conclude later in the year, with data generated from the study intended to inform future regulatory submissions and guide commercialization strategy. 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. Final execution remains subject to completion of the Statement of Work, cost schedules, and a Clinical Trial Research Agreement under the MSA framework. Additional information about the company can be found at https://www.synbiointl.com.
