Arizona Tribune - Revolutionizing Mental Health: AI-Powered Facial Screening Technology Set for Clinical Trials

NEW YORK CITY, NY / ACCESS Newswire / February 25, 2025 / Synbio International Inc. (Synbio) is pleased to announce that it will conduct clinical trials to validate innovative AI-powered facial analysis software for non-invasive medical screening (NIMS) for depressive symptoms. FacialDx Inc. (FacialDx), an innovative AI-digital health company, developed this cutting-edge technology with the potential to revolutionize the early identification of mental health conditions.

Under a Clinical Trial License Agreement with FacialDx, Synbio will undertake trials to validate NIMS's accuracy, reliability, and scalability. The first trial will involve a retrospective feasibility study. If this trial is deemed a success, a larger prospective validation trial will follow. Upon successful validation, Synbio will secure licensing rights to commercialize NIMS into clinical and corporate settings.

The NIMS Software

NIMS employs advanced AI and machine learning algorithms, integrated into an app, that analyzes facial features from high-definition images captured by mobile phones or desktop devices. This technology provides instant results, enabling clinicians to swiftly and cost-effectively identify signs of depression.

In a joint statement, CEOs Claudio Solitario of Synbio and Doug Benoit of FacialDx shared their excitement about the partnership:

"We are thrilled to announce our collaboration to validate and commercialize NIMS. Synbio and FacialDx share a deep-seated vision of harnessing artificial intelligence to assist in the screening of mental health conditions. Designed for seamless integration into clinical practices and corporate platforms, NIMS has the potential to make mental health evaluations more accessible than ever before. By helping to break down the barriers to early diagnosis by early detection, this groundbreaking innovation can redefine the future of mental healthcare, profoundly transforming the lives of patients, their families and friends".

A Breakthrough in AI-Based Mental Health Screening

Inspired by decades of research by Dr. Todd Frisch, NIMS provides a fast, non-invasive, and highly accurate screening method. The AI-driven software behind NIMS is built on over 40 years of medical observations and detailed documentation related to facial and psychological health conditions. By leveraging this extensive research, NIMS has developed AI tools capable of detecting subtle facial features that signal behavioral issues.

Unlike traditional assessments that rely on subjective reporting, NIMS will provide healthcare professionals with objective, data-driven, physiological analysis that will complement traditional diagnostic methods, reducing the risk of non-diagnosis or misdiagnosis.

Market Opportunity - Addressing a Growing Need

The U.S. medical device market is expected to reach $6.45 billion by 2029, indicating a strong demand for innovative tools that enhance early detection and intervention. The benefits of NIMS are many. NIMS aligns with the industry's push toward precision medicine and personalized healthcare.

Importantly, it has the potential to lower healthcare costs by facilitating earlier diagnoses than traditional methods allow, and by reducing the need for frequent in-person evaluations. With continuous use, it will provide healthcare professionals with timely insights into treatment effectiveness, allowing for prompt adjustments that can improve patient outcomes.

Furthermore, remote monitoring capabilities can make mental health assessments more accessible, benefiting individuals in underserved or remote areas.

Commercial Strategy - Expanding Access to Mental Health Support

Synbio's commercial strategy aims to engage health professionals and forge corporate partnerships to maximize NIMS impact. Key focus areas will include but not be limited to:

• Medical Practitioners: By collaborating with family physicians, general practitioners and mental health professionals such as psychologists, therapists and counsellors, NIMS will be integrated into clinical settings, providing professionals with a rapid, objective tool to enhance diagnostic accuracy and patient care.

• Corporate Partnerships: NIMS will support employee wellness in sectors such as aviation, law enforcement, emergency services and veterans' affairs. This support may include routine, non-invasive screenings for airline pilots and first responders who are often exposed to high-stress environments, helping to identify early signs of depression and improve mental health outcomes and productivity. Additionally, insurance companies may utilize NIMS as an objective tool to confirm or rule out the presence of depression, enhancing the accuracy of mental health assessments in underwriting and claims evaluations.

• Direct-to-Consumer Options: The Company will also explore ways to offer NIMS directly to consumers, enabling proactive mental health monitoring with appropriate professional guidance.

Path to Regulatory Approval

Clinical validation will be a top priority. FDA approval will be sought to ensure that NIMS meets the highest medical and ethical standards paving the way for widespread adoption. The results of the feasibility and validation studies will form the basis of the FDA submission.

Bridging the Gap in Mental Health Diagnostics with AI Innovation

Synbio and FacialDx are committed to addressing a critical gap in mental health diagnostics given the total absence of objective testing and the lack of technology-driven solutions to assist in the diagnostic process. By leveraging decades of research and cutting-edge AI technology, NIMS has the potential to revolutionize how depression is identified and managed. As Synbio and FacialDx embark on clinical trials and regulatory approval efforts, the companies remain dedicated to improving patient outcomes and fostering a future where technology plays a vital role in early detection and intervention.

### END ###

For media inquiries, please contact:
Synbio International Inc.
[email protected]
(646) 359-4854
www.synbiointl.com

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. Examples of forward-looking statements in this press include, among others, statements about our renegotiated settlement agreement. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: our limited operating history; our dependence on third parties for many aspects of our business; general market and economic conditions; technical factors; the availability of outside capital; our receipt of revenues; legislative developments; changes in our expenditures and other uses of cash; our ability to find, recruit and retain personnel in sufficient numbers to support our growth; our ability to manage growth; and general market, economic and business conditions. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

SOURCE: Synbio International Inc.

View the original press release on ACCESS Newswire

M.O.Allen--AT