Synbio International Inc. secures rights to conduct clinical trials for AI-powered depression screening technology (NIMS: Non-invasive Mental Screening).
NIMS is a fast, highly accurate and cost-effective method for detecting depressive symptoms through facial analysis.
NIMS software is integrated into an app, that analyzes facial features from high-definition images captured by a mobile phone or desktop device.
The clinical trials will assess NIMS's accuracy, reliability, and scalability for widespread use.
Successful trial results will support regulatory approval, paving the way for Synbio to integrate NIMS into clinical and corporate settings.
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.
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