Mr. John Luna reports

LIGHT AI ACHIEVES ISO 13485 AND MDSAP CERTIFICATION, ADVANCING REGULATORY READINESS FOR HEALTH CANADA SUBMISSION OF QUICKSCAN SOFTWARE PLATFORM

Light AI Inc. has successfully completed its quality management system audit and has been certified as being in conformity with ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP) by Intertek.

The MDSAP certification confirms that Light AI's quality management system meets internationally recognized standards for the design, development, manufacture and distribution of AI/ML-(artificial intelligence/machine learning)-powered devices used to screen, monitor and assist in the detection of ENT infections management of medical devices and software-as-a-medical-device technologies for Canada, the United States and Australia.

Achievement of MDSAP and ISO 13485 certification represents a significant regulatory milestone for the company and supports its planned regulatory submissions for its QuickScan and QuickScan Strep A software platforms in Canada.

The certification covers the company's quality management processes associated with the development of QuickScan software-based medical technologies and establishes the operational framework required to support continuing regulatory, clinical and commercialization activities.

"As we continue executing our regulatory strategy, achieving MDSAP and ISO 13485 certification is an important accomplishment for Light AI," said John R. Luna, chief executive officer of Light AI. "This certification demonstrates our commitment to maintaining a robust medical device quality management system and reflects the significant work completed by our team to align our operations with internationally recognized medical device standards. With this milestone achieved, we are positioned to advance our planned Health Canada regulatory submissions for QuickScan Strep A."

The company's QuickScan Strep A platform is being developed as software-as-a-medical-device solutions intended to support health care professionals in the assessment of patients presenting with symptoms consistent with pharyngitis and potential Group A Streptococcus (Strep A) infection.

MDSAP allows recognized auditing organizations to conduct a single regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple participating regulatory jurisdictions including Canada, Australia and the United States. ISO 13485 is the internationally recognized quality management standard specific to the medical device industry and is widely utilized by regulators and manufacturers globally.

Light AI believes that completion of its MDSAP and ISO 13485 certification establishes an important foundation for future regulatory submissions, including the company's planned Health Canada medical device licence application for QuickScan Strep A.

The company will continue to advance its regulatory, clinical validation and commercialization activities, and expects to provide updates regarding Health Canada submission timing and other key milestones as appropriate.

About Light AI Inc.

Light AI is a technology company focused on developing artificial intelligence health screening and diagnostic solutions. Light AI QuickScan is a technology platform which represents the next generation of patient management: it applies AI algorithms to compatible smart device images, starting with images of Strep A and anticipated expansion with other medical conditions, to identify the disease in seconds. Its patented, app-based solution requires no swabs, lab tests or proprietary hardware of any kind as its computing platform includes the 4.5 billion smart phones that exist in the world today. Light AI is at the forefront of developing innovative screening and diagnostic solutions aimed at improving health are delivery worldwide. Their cutting-edge AI-powered technology offers rapid, accurate, and cost-effective screening and diagnostic tools designed to address critical health care challenges.

In pre-FDA (Food and Drug Administration) validation studies, Light AI's algorithm demonstrated remarkable accuracy in differentiating between viral and bacterial pharyngitis, specifically targeting Group A Streptococcus (GAS). The algorithm achieved a 96.57-per-cent accuracy rate and attained a negative predictive value of 100 per cent, indicating its high reliability in confirming the absence of Streptococcus A infection. Viral and GAS pharyngitis affects over 600 million people annually worldwide. If left untreated, GAS pharyngitis can lead to serious complications such as Rheumatic Heart Disease (RHD), which imposes a global economic burden exceeding $1-trillion annually. Light AI's technology offers a significant advancement in the accurate and timely identification of GAS pharyngitis, potentially reducing the incidence of RHD and its associated costs. Light AI's approach to applying AI to smart device images can be expanded to other medical conditions, as well as other areas of analysis. Light AI's vision is to combine the Light AI QuickScan software platform with AI in the cloud to create a digital clinical lab that provides quick and accessible diagnosis for countless conditions that today require expensive and time-consuming imaging or lab processes.

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