Dr. Sina Habibi reports

COGNETIVITY NEUROSCIENCES ANNOUNCES SUCCESSFUL REGISTRATION WITH AUSTRALIAN THERAPEUTIC GOODS ADMINISTRATION FOR CLINICAL USE OF COGNICATM AI-POWERED BRAIN HEALTH TECHNOLOGY IN AUSTRALIA AND NEW ZEALAND

Cognetivity Neurosciences Ltd. has completed registration for its CognICA cognitive assessment system with the Therapeutic Goods Administration of Australia under the Therapeutic Goods (Medical Devices) Regulations 2002, ARTG identifier 429151. This registration allows the company to market the medical device commercially for clinical use in Australia.

Commenting on the announcement, Dr. Sina Habibi, Cognetivity's chief executive officer, said: "We are pleased to announce our Australian TGA registration, which opens up a major new market for us which, in common with all health care systems the world over, has a significant unmet need for early detection of brain health issues. This is a continuation of our ongoing strategy to expand our access to high-value health care markets, where, sadly, there is much work to be done to tackle the public health crisis in Alzheimer's disease and dementia. Given the urgent and huge need for early detection in the light of new drugs from Eisia and Lilly for Alzheimer's disease coming to market, and CognICA's unique capabilities to detect patients at scale in the early stage of disease necessary for these drugs to be effective, this continues to develop major opportunities for the company."

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, and 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 7.4 million Australians aged 55 and above have not been detected or received any formal diagnosis. Regular testing 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, and CognICA is currently in use detecting patients for this drug in the United States. Similarly, another future 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 treatment to be effective, as demonstrated in the company's published results from real-world commercial deployments. Forecasts for annual sales for Alzheimer's treatment drugs by 2032 range from $6.5-billion to $17-billion in the U.S. alone, according to a Visible Alpha report, but growth is constrained by the limitations of current standard-of-care detection rates, something that can be increased by the use of CognICA at scale.

CognICA has already been registered for clinical use in the U.S., has European regulatory approval as a CE (Conformite Europeenne)-marked medical device, and is also registered in Canada and the UAE (United Arab Emirates). The technology has been deployed for primary and specialist clinical care, and to give early warning of brain health issues both in the clinic and at patients' homes in the U.S. (including identifying patients for Eisai's Leqembi Alzheimer's drug at a U.S. top-25 health provider), Middle East, United Kingdom, Singapore and Japan. This announcement enables access to Australia, a major market for digital heath, the market size for which has been estimated by Insights10 at reaching $10.6-billion by 2030.

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 to better enable health care professionals in their diagnosis. 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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