Synbio International Inc. (OTC: SYIN) announced that it has executed a Master Services Agreement with CRO Services Pty Ltd, a subsidiary of Resonance Health Ltd, to conduct a proof-of-concept clinical trial in Australia. The trial will evaluate FacialDx's proprietary NIMS (Non-invasive Medical Screening) technology, an AI-powered facial analysis system designed to identify early-stage features associated with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD).
The trial aims to assess the accuracy, reliability, and clinical utility of the technology in real-world clinical conditions. While internal non-clinical testing has shown promising performance, this study represents a critical step toward clinical validation, which is essential for potential regulatory engagement and commercial adoption. 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 (FDA). Conducting the trial in Australia offers efficiencies in cost and timeline while maintaining internationally recognized clinical and ethical standards.
Mental health conditions are among 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. Current screening methods rely heavily 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 and more consistent screening across clinical and corporate settings.
Beyond screening, the technology may be used repeatedly over time to assist clinicians in objectively assessing patient progress and treatment response. It is proactive, non-invasive, rapid, and scalable, with potential applications in primary care, behavioral health, psychiatry, corporate wellness, occupational health programs, and high-risk industries where early identification may improve safety and productivity. Together, these markets represent a substantial long-term opportunity for Synbio.
Claudio Solitario, Chief Executive Officer of Synbio International, stated, 'This agreement marks a major milestone for Synbio. 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.' He added, '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. Data generated from the study is intended to inform future regulatory submissions and guide commercialization strategy in both healthcare and corporate markets. 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.
