Mr. John Luna reports

LIGHT AI PROVIDES QUICKSCAN STREP A PRODUCT DEVELOPMENT UPDATE

Light AI Inc. will keep its QuickScan strep A software as a medical device in controlled product development and continue its hold on related clinical activities.

Management made this decision following a preliminary product, quality, and verification and validation assessment that identified gaps in the objective evidence currently available to substantiate performance of the complete QuickScan strep A system across its intended use population and use environment. The assessment includes machine learning development and validation evidence, data sets, image acquisition and processing, software and system V&V, design controls, usability, cybersecurity, and supporting quality system documentation.

As a result, the company will not resume external clinical validation or advance toward a U.S. Food and Drug Administration submission until the product configuration and supporting objective evidence establish readiness for clinical use.

Action plan

The company will undertake a structured technical and quality action plan that will include:

• Continuing the hold on its New Zealand feasibility activities and planned U.S. clinical study;
• Conducting an independent robustness assessment of the existing machine learning model and supporting data sets;
• Determining whether the existing model can be remediated and/or retrained or whether redevelopment is required;
• Continuing to evaluate controlled imaging alternatives to the current smart-phone-based image acquisition approach; and
• Completing the required design control, quality system and system-level V&V activities.

The preliminary assessment has not reached a conclusion on the underlying technology's ability to achieve its target performance or on whether the existing machine learning model can be retrained rather than redeveloped. Those questions will be addressed through the independent robustness assessment described above. Management has concluded that the company does not currently have sufficient objective evidence to rely upon the existing product configuration and validation package for further clinical deployment or advancement toward an FDA submission without additional development, remediation, and V&V.

Expected implications

The timing of the company's previously contemplated U.S. clinical and FDA regulatory activities is being reassessed. The company will not provide a revised timetable until the relevant development, remediation, and V&V work has progressed sufficiently to support a reliable assessment of next steps.

"Patient safety, product performance and objective scientific evidence are the foundation of our development program," said John R. Luna, chief executive officer and director of Light AI. "Our review identified gaps in the evidence supporting the performance of the complete QuickScan system, and we are addressing them directly. Before we resume clinical studies, we intend to complete the development, design control and validation work necessary to establish that the product performs as intended across its intended use population and use environment. This is a setback in timing, but doing this work now is the right path to building a product that clinicians and patients can rely on."

The company's Health Canada Class 2 medical device licence, as disclosed in the company's news release dated Aug. 12, 2026, remains in effect. The company is assessing the findings of its review and any resulting regulatory obligations in consultation with its regulatory advisers.

The company expects to provide its next update when it has reached material milestones or decisions regarding the machine learning assessment, imaging architecture, remediation program, clinical activities or regulatory strategy.

About Light AI Inc.

Light AI is a health care technology company focused on developing artificial-intelligence-powered SaMD 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.

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