Mr. John Luna reports

LIGHT AI RECEIVES HEALTH CANADA MEDICAL DEVICE LICENSE FOR QUICKSCAN STREP A

Health Canada has issued a Class 2 medical device licence for Light AI QuickScan Strep A, Light AI Inc.'s first product developed on its QuickScan artificial intelligence platform.

Health Canada issued medical device licence No. 115921 for Light AI QuickScan Strep A, classified as a Class 2 medical device, with a first issue date of Aug. 10, 2026. The Health Canada listing identifies the device as LAI-QS-A-001.

The licence represents a major regulatory milestone for Light AI and enables the company to advance toward the commercial introduction of QuickScan Strep A in Canada.

QuickScan Strep A is an artificial-intelligence-powered clinical decision support software as a medical device designed to assist health care professionals in the assessment of patients presenting with symptoms consistent with Group A streptococcal pharyngitis. The software uses machine learning and digital images of the throat to provide health care professionals with rapid clinical decision support at the point of care.

"Receiving our Health Canada medical device licence for QuickScan Strep A is a defining milestone for Light AI," said John R. Luna, chief executive officer of Light AI. "We have spent years developing the technology, building the clinical evidence, establishing a world-class quality system and preparing the company to transition from product development to commercialization. Today, that transition becomes a reality."

Mr. Luna continued: "Canada represents an ideal first commercial market for QuickScan Strep A. Our vision is to provide health care professionals with rapid, accessible and scalable AI-powered clinical decision support that can help improve the assessment of sore throat patients while fitting efficiently into existing health care workflows. With Health Canada licensing now achieved, our focus shifts to commercial execution and bringing QuickScan Strep A to health care providers and patients across Canada."

Advancing QuickScan device-agnostic artificial intelligence software platform

QuickScan is being developed as a device-agnostic SaMD platform, designed to use compatible digital imaging and computing technologies to acquire and analyze images at the point of care. This approach is intended to provide Light AI with flexibility to integrate its software across compatible hardware platforms and health care environments as the company expands its product portfolio.

QuickScan Strep A represents the first commercial application of this platform, with Light AI's longer-term strategy focused on leveraging its artificial intelligence, image analysis and software infrastructure across additional clinical applications.

The Health Canada licence follows another significant regulatory milestone for the company: the achievement of ISO 13485:2016 and medical device single audit program certification, establishing the quality management system foundation supporting Light AI's regulated medical device development and commercialization activities.

Commercialization in Canada

With the Health Canada licence issued, Light AI intends to advance its Canadian commercialization strategy, including engagement with health care providers and potential distribution and commercial partners.

The company believes Canada provides an attractive opportunity for QuickScan Strep A across multiple points of care, including community pharmacies, medical clinics and other health care settings where patients are commonly present with sore throat symptoms.

Light AI expects to provide additional information regarding its Canadian commercialization plans, partnerships and anticipated product availability as those initiatives progress.

"This is not the finish line. It is the starting point for the commercial phase of Light AI," Mr. Luna added. "Our team has accomplished an extraordinary regulatory milestone, and we are now focused on translating that achievement into adoption, revenue, and, most importantly, meaningful benefits for health care professionals and their patients."

About Light AI Inc.

Light AI is a health care technology company focused on developing artificial-intelligence-powered software as a medical device solutions designed to support rapid, accessible clinical assessment at the point of care.

The company's core technology, Light AI QuickScan, is a device-agnostic software platform that applies proprietary artificial intelligence and machine learning algorithms to medical images to provide health care professionals with actionable clinical information within seconds. The QuickScan platform is designed to operate across compatible imaging and computing hardware, providing flexibility for integration into a range of health care devices, clinical workflows and care settings without dependence on a single proprietary hardware platform.

The first product being brought to market on the platform, Light AI QuickScan Strep A, uses artificial intelligence to analyze images of the throat and provide clinical decision support regarding the likelihood of GAS pharyngitis. QuickScan Strep A is designed to provide a rapid, non-invasive assessment without requiring a throat swab or laboratory test as part of the QuickScan analysis.

Light AI is developing the QuickScan platform with the potential to support additional medical conditions and clinical applications over time. The company's long-term vision is to combine its QuickScan SaMD platform, advanced imaging and cloud-based artificial intelligence to create a scalable digital clinical lab capable of delivering rapid and accessible clinical insights across multiple diseases and conditions.

In pre-Food and Drug Administration validation studies, Light AI's Strep A algorithm demonstrated 96.57-per-cent accuracy in differentiating between viral and bacterial pharyngitis and achieved a negative predictive value of 100 per cent for Group A streptococcus. Viral and GAS pharyngitis affect hundreds of millions of people globally each year, and untreated GAS infection can result in serious complications, including rheumatic heart disease.

Light AI believes its device-agnostic software architecture and artificial intelligence platform have the potential to expand access to rapid clinical decision support across diverse health care environments worldwide.

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