Mr. John Luna reports

LIGHT AI ANNOUNCES INITIATION OF FDA PIVOTAL CLINICAL TRIAL FOR QUICKSCAN STREP A SOFTWARE AS A MEDICAL DEVICE (SAMD)

Light AI Inc. has initiated its FDA (U.S. Food and Drug Administration) pivotal clinical trial for QuickScan Strep A, the company's investigational software as a medical device (SaMD) designed to assist in the assessment of suspected Group A streptococcus (Strep A) pharyngitis.

The company has received ethics committee approval to commence the study. The pivotal clinical trial is intended to generate clinical evidence to support a future submission to the FDA for potential marketing authorization of QuickScan Strep A as a Class II medical device.

The study protocol and design are informed by prior regulatory interactions, including presubmission feedback received by the company during its 2024 FDA Q-Sub process. Light AI believes the study is appropriately designed to support its planned regulatory submission strategy; however, no assurance can be provided regarding the outcome of any FDA review or authorization process.

QuickScan Strep A is being developed as a smart-phone-enabled software platform intended to analyze throat images and provide an AI-supported (artificial intelligence) assessment for suspected Strep A infection. The software remains investigational and has not been cleared or approved by the FDA or other regulatory authorities for commercial diagnostic use.

The pivotal study is expected to enroll participants presenting with symptoms consistent with pharyngitis and is designed to compare the diagnostic performance of QuickScan Strep A against throat culture, an established clinical reference standard. Predefined study end points include diagnostic outcome measures, usability assessments and patient-management-related measures intended to support evaluation of software performance and a future FDA submission.

"Commencing our pivotal clinical trial following ethics committee approval represents an important operational and regulatory milestone for Light AI," said John R. Luna, chief executive officer of Light AI. "Our objective is to generate the clinical evidence required to evaluate QuickScan Strep A in a rigorous, regulated setting and support a future FDA submission. We believe scalable software-enabled assessment tools may have the potential to support health care workflows, subject to clinical study outcomes, regulatory authorization, reimbursement considerations and commercial adoption."

Strep A pharyngitis is a common condition evaluated across primary care, urgent care, pediatric, pharmacy and community health care settings. Subject to successful clinical validation, regulatory authorization and commercial adoption, Light AI believes there may be future opportunities for software-enabled assessment technologies to support health care delivery and patient management pathways.

The company expects to provide updates regarding study progress, enrolment milestones and timing considerations as appropriate and in accordance with applicable securities disclosure obligations.

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 care delivery around the world. The company's 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 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 Strep A infection. Viral and GAS pharyngitis affects over 600 million people annually around the world. 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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