Dr. Sina Habibi reports

COGNETIVITY NEUROSCIENCES ANNOUNCES SUCCESSFUL REGISTRATION WITH HEALTH CANADA FOR CLINICAL USE OF COGNICA(TM) AI-POWERED BRAIN HEALTH TECHNOLOGY IN CANADA

Cognetivity Neurosciences Ltd. has completed registration for its groundbreaking CognICA cognitive assessment system with Health Canada under Medical Devices Regulations (SOR/98-282). This registration allows the company to market the medical device commercially for clinical use in Canada.

Commenting on the announcement, Dr. Sina Habibi, Cognetivity's chief executive officer, said: "We are pleased to announce our Health Canada registration, in particular as it is not just a major health care market but also one of our home jurisdictions and one where there is a significant unmet need for early detection of brain health issues. This is part of our ongoing strategy to expand our access to new high-value health care markets, where, sadly, there is much work to be done to tackle the public health crisis in dementia. Given the urgent and huge need for early detection in the light of new drugs for Alzheimer's disease coming to market, and CognICA's unique capabilities to do this at scale, we would welcome contact from potential collaborators in Canada who share the same ambitions and interests."

CognICA is a five-minute, computerized cognitive assessment, incorporating artificial intelligence (AI) delivered via Apple iPad devices. It offers numerous benefits to clinicians and patients, particularly in comparison with traditional, pen-and-paper-based tests. These include high sensitivity to early-stage cognitive impairment which allows reliable detection of patients at the early stages of diseases such as Alzheimer's, lack of cultural or educational bias and absence of learning effect upon repeat testing, enabling reliable monitoring of patient progress. CognICA is also capable of supporting remote, self-administered testing at scale and is geared toward seamless integration with existing electronic health record (EHR) systems.

The prevalence of mild cognitive impairment (MCI) for people aged above 60 is around 10 per cent, a rate which doubles every additional 10 years of life. Currently, the majority of the MCI population within the seven million Canadians aged 60 and above have not been detected or received any formal diagnosis. Regular screening of the population allows for early stage detection of MCI, diagnosis and intervention, which is only effective at the early stage of impairment. For example Leqembi, a disease modifying drug for Alzheimer's developed by Eisai, which recently received full FDA (Food and Drug Administration) approval has been shown to slow down disease progression by 27 per cent if applied at the early stage of disease. Similarly, another upcoming drug for Alzheimer's, Donanemab, developed by Eli Lilly reported a 35-per-cent decline in rate of impairment, but again only if applied at the MCI stage. CognICA's ease of use and sensitivity allows for regular mass scale detection programs to identify patients at the early stage required for effective intervention, and furthermore the platform's AI enables powerful monitoring and population health management. Forecasts for annual sales for Alzheimer's treatment drugs by 2032 range from $6.5-billion to $17-billion, dependent on a significant improvement in detection and diagnosis at the early stage, according to a Visible Alpha report.

CognICA has already been registered for clinical use in the United States, as well as having European regulatory approval as a CE-marked medical device, and has been deployed for primary and specialist clinical care and to give early warning of brain health issues both in the clinic and at home in the U.S., Middle East, United Kingdom, Singapore and Japan. This announcement enables access to Canada, a major market for digital heath, the market size for which was valued at $17-billion in 2022 and is estimated to expand annually at 18.6 per cent from 2022 to 2030, reaching $66-billion in 2030. The rising popularity of remote patient monitoring services is a major driving factor in this Canada home health care market growth, a key capability of Cognetivity's CognICA platform.

Cognetivity Neurosciences remains dedicated to utilizing its AI platform technology to transform the landscape of brain health globally, enhance the quality of care provided to patients, and to reduce the burden and cost to providers and payers, delivering the company's vision of A Brighter Mind for a Fuller Life.

About Cognetivity Neurosciences Ltd.

Cognetivity is a technology company that has developed a cognitive testing platform for use in medical, commercial and consumer environments. Cognetivity's CognICA uses artificial intelligence and machine learning technology to test the performance of large areas of the brain to help detect early signs of cognitive dysfunction. CognICA is currently available for clinical use in the United States, United Kingdom, Europe, Canada and the Middle East, with regulatory approval in other regions expected later in 2023.

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