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

Ethics Committee Approval Received for Pivotal Study Intended to Support U.S. FDA Class II Submission for QuickScan™ Strep A

VANCOUVER, BC, June 4, 2026 /CNW/ - Light AI Inc. ("Light AI" or the "Company") (CBOE CA: ALGO) (FSE: OHC) (OTCQB: OHCFF), a digital healthcare technology company focused on developing artificial intelligence ("AI") health diagnostic solutions, is pleased to announce that today announced the initiation of its FDA 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 U.S. Food and Drug Administration ("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 pre-submission 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 smartphone-enabled software platform intended to analyze throat images and provide an AI-supported 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 endpoints 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 healthcare 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 healthcare 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 healthcare delivery and patient management pathways.

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

For more information, please contact the Company at [email protected] or visit https://light.ai/.

Website: https://light.ai/
LinkedIn: LinkedIn/company/Light AI 
X (Formerly Twitter): @lightaihealth

Forward-Looking Information

This news release contains forward-looking statements and forward-looking information within the meaning of applicable Canadian securities legislation (collectively, "forward-looking statements"), including but not limited to statements regarding the anticipated scope, timing, enrollment, objectives, endpoints, execution, completion, and expected outcomes of the pivotal clinical trial; the Company's planned FDA submission and regulatory strategy; potential regulatory authorization; anticipated software functionality; future commercialization opportunities; and the Company's business strategy, development plans, and market opportunities.

Forward-looking statements are based on management's current expectations, assumptions, and beliefs as of the date of this news release and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those expressed or implied, including risks relating to clinical trial execution, enrollment and completion, data quality, protocol adherence, regulatory review and outcomes, technology performance, market conditions, financing requirements, intellectual property, commercialization, reimbursement, competition, and general business, economic and capital market conditions.

QuickScan™ Strep A is an investigational product and has not been approved or cleared by the U.S. Food and Drug Administration or any other regulatory authority for diagnostic use. There can be no assurance that clinical trial results will support a successful FDA submission, regulatory authorization or commercialization.

Readers are cautioned not to place undue reliance on forward-looking statements. Except as required by applicable law, the Company undertakes no obligation to update or revise forward-looking statements to reflect new events or circumstances.

About Light AI Inc. (CBOE CA: ALGO / FSE: OHC / OTCQB: OHCFF)

Light AI Inc. 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 smartphones that exist in the world today. Light AI is at the forefront of developing innovative screening and diagnostic solutions aimed at improving healthcare delivery worldwide. Their cutting-edge AI powered technology offers rapid, accurate, and cost-effective screening and diagnostic tools designed to address critical healthcare 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% accuracy rate and attained a Negative Predictive Value of 100%, 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.

SOURCE Light AI Inc.

For more information, please contact: John R. Luna, Chief Executive Officer, Telephone: [phone], Email: [email protected]