Mr. Andre Larente reports

DIAGNOS RECEIVES SAUDI FDA MEDICAL DEVICE LICENSE FOR CARA SYSTEM, BRINGING AI-ASSISTED RETINAL IMAGE ANALYSIS TO SAUDI ARABIA

Diagnos Inc. has received medical device marketing authorization for the CARA system from the Saudi Food and Drug Authority (SFDA).

The version of CARA licensed in Saudi Arabia includes detection algorithms for diabetic retinopathy (DR) and age-related macular degeneration (AMD). CARA provides, in a short period of time and at an affordable unit cost, valuable insights to the health care provider, ultimately improving quality of life for the patient.

According to the International Diabetes Federation, the adult population in Saudi Arabia was 25 million people in 2024 with a prevalence of diabetes of 23 per cent, representing an addressable market of over five million adults to be screened regularly for DR and AMD.

"Registering and receiving the authorization to market the CARA platform in Saudi Arabia from the SFDA represents a milestone in our commercialization efforts for Saudi Arabia," said Yves-Stephane Couture, chief operating officer of Diagnos.

"For more than a decade, Diagnos has been developing retinal image analysis using AI technologies through collaborations with clinicians and health care organizations worldwide, driven by one mission -- help prevent avoidable blindness," said Andre Larente, president and chief executive officer of Diagnos. "Following our recent approval from Health Canada announced on July 27, 2026, this additional approval opens new sales opportunities beyond North America."

"The SFDA authorization of CARA is an important achievement not only for Diagnos but also for Quebec's innovation ecosystem," said Philippe Couillard, chairman of the board of Diagnos.

Diagnos main strategy to address the Saudi Arabia market is to rely on local agents and distributors. As such, Diagnos works with a local distributor, Kanhoor Medical, a company providing telemedicine and remote patient treatment.

About Diagnos Inc.

Diagnos is a public Canadian corporation dedicated to the early detection of critical eye-related health problems. By developing innovative products based on AI (artificial intelligence) technologies, Diagnos's solutions provide health care clinicians with valuable information that refines diagnostic accuracy, streamlines workflows and improves patient outcome.

We seek Safe Harbor.