Mr. Andre Larente reports

Diagnos TO FILE FOR FDA PRE-MARKET AUTHORIZATION OF ITS AI-POWERED CARA SYSTEM AND ENGAGES ORA AS REGULATORY SPECIALIST

Diagnos Inc. is officially filing for United States Food and Drug Administration (FDA) premarket authorization of its CARA System, a machine-learning-enabled medical device (MLMD). To ensure a smooth regulatory process, Diagnos has engaged Ora, a leading clinical research organization specializing in regulatory affairs and clinical development for ophthalmic products.

The CARA System is designed to assist optometrists and front-line health care professionals in analyzing fundus images for the early detection of diabetic retinopathy, age-related macular degeneration and hypertensive retinopathy. By leveraging artificial intelligence, Diagnos aims to enhance diagnostic accuracy, streamline workflows and improve patient outcomes on a global scale.

Strategic partnership to facilitate U.S. market entry

This collaboration with Ora represents a major milestone in Diagnos's expansion strategy. With extensive experience in guiding ophthalmic products through regulatory approvals, Ora will play a pivotal role in navigating the U.S. regulatory landscape and ensuring a successful FDA submission process.

"Diagnos is committed to revolutionizing eye health through artificial intelligence technologies," said Andre Larente, chief executive officer of Diagnos. "Our expertise in artificial intelligence driven Diagnostics is helping to improve patient outcomes worldwide. The optometry market comprises over 300,000 sites globally and our recent partnership with the largest player in the industry will significantly boost our visibility. Additionally, our government-related business initiatives are resuming, marking an exciting phase of growth for Diagnos."

About Diagnos Inc.

Diagnos is a publicly traded Canadian corporation dedicated to early detection of critical health problems based on its Flaire artificial intelligence (AI) platform. Flaire allows for quick modifying and developing of applications such as CARA (computer-assisted retina analysis). CARA's image enhancement algorithms provide sharper, clearer and easier-to-analyze retinal images. CARA is a cost-effective tool for real-time screening of large volumes of patients.

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