Synbio Signs Agreement for a Proof-of-Concept Clinical Trial to Evaluate a Unique AI-Based Facial Analysis Screening Software for Mental Health Disorders

(TheNewswire)

• Synbio has signed a Master ServicesAgreement with a leading Australian clinical research organization,CRO Services Pty Ltd, a wholly owned subsidiary of ASX-listedResonance Health Ltd (ASX: RHT). 

• Under the agreement, Resonance willconduct a proof-of-concept clinical trial to assess the efficacy ofFacialDx Incorporated (FacialDx) NIMSTM (Non-invasive Medical Screening)technology and evaluate its performance in real-world clinicalconditions. 

• Facial DX NIMSTM is a proactive, non-invasive AI-poweredwellness technology that analyzes facial imagery to potentially assistin the early identification of life-changing health conditions such asPost-Traumatic Stress Disorder and Major Depressive Disorder. 

• Mental health is discussed inapproximately 150 million1 clinical interactions annually in theU.S., where mental health is discussed, with additional opportunitiesin corporate wellness programs.  

• Successful validation positionsSynbio to pursue commercialization across both clinical and corporatesettings, creating considerable opportunities for significantshareholder value.  

New York, NY –January 15, 2026 – TheNewswire - Synbio International Inc.(OTC: SYIN) (“Synbio” or the “Company”), a medical technologycompany focused on clinically validated AI diagnostics, todayannounced that it has executed a Master Services Agreement (“MSA”)with CRO Services Pty Ltd (“CRO Services”), a leading Australianclinical research organization and a wholly owned subsidiary ofResonance Health Ltd (“Resonance”) (ASX: RHT).

Under the agreement, CRO Services will conduct aproof-of-concept clinical trial in Australia to evaluate FacialDx’sproprietary NIMS™ (Non-invasive MedicalScreening) technology.  

The technology is a proactive AI-powered facialanalysis medical health technology that identifies early-stagefeatures associated with (amongst other medical indications), twohighly prevalent and costly mental health conditions: Post-Traumatic Stress Disorder (PTSD) and Major Depressive Disorder(MDD).

Advancing Toward Clinical Validation

The trial is designed to assess the accuracy,reliability, and clinical utility of the technology in real-worldclinical conditions. While internal non-clinical testing hasdemonstrated promising performance, this studyrepresents a critical step toward clinical validation - an essentialrequirement for potential regulatory engagement and commercialadoption.

Resonance Health brings extensive experience inconducting clinical studies and supporting medical technologiesthrough regulatory pathways, including prior engagement with the U.S.Food and Drug Administration (FDA). Conducting the trial in Australiaoffers meaningful efficiencies in cost and timeline while maintaininginternationally recognized clinical and ethical standards.

Addressing a Large and Underserved Market

Mental health conditions are among the most common andcostly challenges facing healthcare systems and employers. In theUnited States alone, mental health is discussed or assessed in anestimated 150 million2 primary care visitsannually - excluding specialty visits, emergency care andothers.  

Despite this scale, mental health screening todayremains heavily reliant on subjective questionnaires andself-reporting, which can be influenced by stigma, recall bias, andclinician interpretation.

The technology is designed to supplement — notreplace — clinical judgment by providing objective biological dataderived from facial analysis. If clinically validated, it mayrepresent the world’s first objective screening test for a mentalhealth condition, enabling earlier identification, more consistentscreening, and improved decision-support across both clinical andcorporate settings.

Beyond screening and subject to clinical validation,the technology may be used repeatedly over time to assist cliniciansin objectively assessing patient progress and treatmentresponse.

The technology is proactive, non-invasive, rapid, andscalable, with potential applications across clinical healthcaresettings (i.e. primary care, behavioural health, psychiatry);corporate wellness and occupational health programs and high-riskindustries where early identification may improve safety, resilience,and productivity.

Together, these markets represent a substantial andcomplementary long-term opportunity for Synbio.

Strategic Importance

“This agreement marks a major milestone forSynbio,” said Claudio Solitario, Chief Executive Officer of SynbioInternational. “Clinical validation is the foundation for regulatoryengagement and commercial deployment. The need for objective, scalablemental health screening tools has never been greater - MajorDepressive Disorder is now one of the leading causes of disabilityamong Americans aged 15 to 44.”

“Our focus is on empowering clinicians with anaffordable, easy-to-use tool that enhances existing workflows,”Solitario added. “Importantly, NIMS is based on the patient’s ownbiological data and does not rely solely on subjective interpretation,addressing a long-standing industry challenge.”

NextSteps

The trial is expected to commence in early 2026 andconclude later in the year. Data generated from the study is intendedto inform future regulatory submissions and guide commercializationstrategy in both healthcare and corporate markets.

The trial will be conducted under Synbio’s clinicaland regulatory leadership, pursuant to its agreement with FacialDxInc., the developer of the underlying facial analysis technology.Final execution remains subject to completion of the Statement ofWork, cost schedules, and a Clinical Trial Research Agreement underthe MSA framework.

###

AboutSynbio International Inc.

Synbio International Inc. (OTC: SYIN) is a medical research andtechnology company focused on clinically validated AI-driven medicaldiagnostics. Through strategic partnerships and researchcollaborations, Synbio aims to bridge the gap between wellness andmedicine, developing science-based solutions that improve quality oflife and empower healthcare providers.

For media inquiries, pleasecontact:
Synbio International Inc.
info@synbiointl.com
(646) 359-4854
www.synbiointl.com

Forward-Looking Statements

This press release contains “forward-lookingstatements” within the meaning of the safe harbor provisions of thePrivate Securities Litigation Reform Act of 1995. Forward-lookingstatements can be identified by words such as: “anticipate,”“intend,” “plan,” “goal,” “seek,” “believe,”“project,” “estimate,” “expect,” “strategy,”“future,” “likely,” “may,” “should,” “will” andsimilar references to future periods. Examples of forward-lookingstatements in this press include, among others, statements about ourrenegotiated settlement agreement. Forward-looking statements areneither historical facts nor assurances of future performance.Instead, they are based only on our current beliefs, expectations, andassumptions regarding the future of our business, future plans, andstrategies, projections, anticipated events and trends, the economyand other future conditions. Because forward-looking statements relateto the future, they are subject to inherent uncertainties, risks andchanges in circumstances that are difficult to predict and many ofwhich are outside of our control. Our actual results and financialcondition may differ materially from those indicated in theforward-looking statements. Therefore, you should not rely on any ofthese forward-looking statements. Important factors that could causeour actual results and financial condition to differ materially fromthose indicated in the forward-looking statements include, amongothers, the following: our limited operating history; our dependenceon third parties for many aspects of our business; general market andeconomic conditions; technical factors; the availability of outsidecapital; our receipt of revenues; legislative developments; changes inour expenditures and other uses of cash; our ability to find, recruitand retain personnel in sufficient numbers to support our growth; ourability to manage growth; and general market, economic and businessconditions. Any forward-looking statement made by us in this pressrelease is based only on information currently available to us andspeaks only as of the date on which it is made. We undertake noobligation to publicly update any forward-looking statement, whetherwritten or oral, that may be made from time to time, whether as aresult of new information, future developments or otherwise.

1 In the U.S., there are approximately 1.0 billion physicianoffice visits per year (ambulatory care) in which patients see adoctor or other health professional.  A nationally representativeanalysis found that about 15.9% of primary care visits address amental health concern — meaning mental health was talked about atsome point in the visit.  Using this proportion with the approximate1.0 billion office visits suggests an estimated 150 million primarycare visits annually involve mental health discussion — though thisexcludes specialty visits, emergency care, paediatrics, and others. Source: National Center for Health Statistics – Ambulatory CareUse and Physician Office Visits.

2 In the U.S., there areapproximately 1.0 billion physician office visits per year (ambulatorycare) in which patients see a doctor or other health professional.  Anationally representative analysis found that about 15.9% of primarycare visits address a mental health concern — meaning mental healthwas talked about at some point in the visit.  Using this proportionwith the approximate 1.0 billion office visits suggests an estimated150 million primary care visits annually involve mental healthdiscussion — though this excludes specialty visits, emergency care,paediatrics, and others.  Source: National Center for HealthStatistics – Ambulatory Care Use and Physician Office Visits.

Copyright (c) 2026 TheNewswire - All rights reserved.