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Cognetivity Announces Successful Registration With Australian Therapeutic Goods Administration for Clinical use of CognICA AI-Powered Brain Health Technology in Australia and New Zealand

11 January 2024

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

Approval opens up another new market for CognICA, providing a solution to the urgent requirement for large-scale early detection and monitoring for the rollout of approved and upcoming Alzheimer’s disease treatments

Vancouver, British Columbia, January 11, 2024 – Cognetivity Neurosciences Ltd. (“the Company” or “Cognetivity”) (CSE: CGN, OTCQB: CGNSF, FWB.1UB), a technology company that has created a unique Artificial Intelligence (AI) powered brain health screening and monitoring platform for use in medical, commercial and consumer environments, is delighted to announce that it has completed registration for its CognICATM 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 CEO, said: “We are pleased to  announce our Australian TGA registration which opens up a major new market for us which, in common with all healthcare 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 healthcare 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 to 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 towards seamless integration with existing electronic health record (EHR) systems.

The prevalence of Mild Cognitive Impairment (MCI) for people aged above 60 is around 10%, 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 approval has been shown to slow down disease progression by 27% if applied at the early stage of disease, and CognICA is currently in use detecting patients for this drug in the USA. Similarly, another upcoming drug for Alzheimer’s, Donanemab, developed by Eli Lilly, reported a 35% 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 USA 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 USA, has European regulatory approval as a CE-marked medical device and is also registered in Canada and the UAE. 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 USA (including identifying patients for Eisai’s Leqembi Alzheimer’s drug at a US top 25 health provider), Middle East, UK, 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

Cognetivity is a technology company that has developed a cognitive testing platform for use in medical, commercial, and consumer environments. Cognetivity’s CognICATM 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.

About Mediclinic Group

Mediclinic is a diversified international private healthcare services group, established in South Africa in 1983, with divisions in Switzerland, Southern Africa (South Africa and Namibia) and the Middle East. Mediclinic is focused on providing specialist-orientated, multi-disciplinary services across the continuum of care in such a way that the Group will be regarded as the most respected and trusted provider of healthcare services by patients, medical practitioners, funders and regulators of healthcare in each of its markets.


On behalf of the Board of Directors

“Sina Habibi”
Sina Habibi

Chief Executive Officer and Director

forward-looking statements:

Certain statements contained in this news release, including those identified by the words “anticipate,” “assume,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “should” and similar expressions, to the extent they relate to the Company or its management, constitute forward-looking information or statements (collectively, the “Forward-Looking Statements”). These forward-looking statements are not historical facts and reflect current expectations regarding future results or events. This news release contains forward-looking statements. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Such statements are based on current expectations and various estimates, factors and assumptions, and involve known and unknown risks, uncertainties and other factors. Such statements and information are based on a number of assumptions regarding our current and future business strategies and the environment in which we operate. We assume no responsibility to update or revise forward-looking information to reflect new events or circumstances, except as required by law. Readers are cautioned not to place undue reliance on our forward-looking statements.

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