Synbio International Inc. (OTC: SYIN) announced today that it has executed a Master Services Agreement with CRO Services Pty Ltd, a wholly owned 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 study aims to assess the accuracy, reliability, and clinical utility of the technology under real-world conditions. While internal non-clinical testing has shown promising performance, this trial represents a critical step toward clinical validation, which is essential for 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 cost and timeline efficiencies while maintaining internationally recognized clinical and ethical standards.
Mental health conditions are among the most common and costly challenges facing healthcare systems. In the United States alone, mental health is discussed or assessed in an estimated 150 million primary care visits annually, according to data from the National Center for Health Statistics. 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 could 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 initial screening, the technology may be used repeatedly 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, and high-risk industries where early identification may improve safety and productivity.
“This agreement marks a major milestone for Synbio,” said Claudio Solitario, Chief Executive Officer. “Clinical validation is the foundation for regulatory engagement and commercial deployment. The need for objective, scalable mental health screening tools has never been greater.” 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. The trial will be conducted under Synbio’s clinical and regulatory leadership, pursuant to its agreement with FacialDx Inc., the developer of the underlying technology.
