Mr. Andre Larente reports

DIAGNOS ADVANCES REGULATORY STRATEGY FOR CARA IN KEY MARKETS: UPDATES ON HEALTH CANADA, FDA, AND SFDA PROGRESS

Diagnos Inc. has provided an update on the regulatory pathway for its AI (artificial intelligence) platform, CARA. This follows the acceleration plan announced on Oct. 8, 2025.

The corporation continues to execute its strategy to secure approvals in three targeted jurisdictions:

• Saudi Arabia (Saudi Food and Drug Authority (SFDA)): Diagnos has formally submitted CARA for marketing approval to the SFDA.
• Canada (Health Canada): The corporation is actively engaged with Health Canada to ensure full alignment with applicable medical device regulations. Diagnos confirms it is on track to submit its formal application for CARA in the course of this current quarter.
• United States (U.S. Food and Drug Administration (FDA)): Following strategic meetings with the FDA, Diagnos has clarified the specific requirements to secure 510(k) clearance, paving the way for commercialization in the U.S. market.

A word from the chief executive officer

"Navigating the regulatory landscape for medical AI requires precision and expertise. Our team is fully focused on meeting the rigorous standards of Canada, the U.S. and Saudi Arabia," stated Andre Larente, CEO of Diagnos. "Securing these authorizations is a priority milestone that we believe will serve as a significant catalyst for commercial growth and shareholder value."

About Diagnos Inc.

Diagnos is a publicly traded Canadian corporation dedicated to early detection of critical eye-related health problems. By leveraging artificial intelligence, Diagnos aims to provide more information to health care clinicians to enhance diagnostic accuracy, streamline workflows and improve patient outcomes on a global scale.

We seek Safe Harbor.