Cognetivity Neurosciences completes US FDA registration of Integrated Cognitive Assessment

FDA registration grants access for commercial distribution of ICA throughout US healthcare market

Vancouver, British Columbia, October 20, 2021 – Cognetivity Neurosciences Ltd. (the “Company” or “Cognetivity”) (CSE: CGN; OTCQB: CGNSF; FWB: 1UB) today announced that it has received notification from the US Food and Drug Administration (FDA) that its CognICA^TM Integrated Cognitive Assessment (ICA) has been reviewed and found to meet the requirements of regulations 21 CFR 882.1470; 510(k) Class II Exempt Medical Device. The notification allows the company to market the medical device for commercial distribution in the US.

The ICA is a five-minute, computerized cognitive assessment, delivered on iPad devices, that is an adjunctive tool providing objective measures of cognitive function for the clinical evaluation of cognitive performance in individuals aged 55 to 90 years old. It offers numerous benefits to clinicians and patients, particularly in comparison to traditional, pen-and-paper-based tests. These include its high sensitivity to early-stage cognitive impairment, avoidance of cultural or educational bias and absence of learning effect upon repeat testing. Owing to its computerized nature, the ICA 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 ICA has already received European regulatory approval as a CE-marked medical device and has been deployed in both primary and specialist clinical care in the UK’s National Health Service (NHS). Registration with the FDA now grants Cognetivity access to the vast US healthcare market, which is the largest of any country in the world.

Commenting on the announcement, Dr Sina Habibi, Cognetivity’s CEO, said: “We’re delighted to have reached this major company milestone, which is the culmination of many years of hard work. This grants us access to the world’s largest healthcare market, where, sadly, there is much more to be done to tackle the massive problem of dementia. Of course, we’re excited about the opportunity to revolutionize the way cognitive impairment is assessed and managed in the US and make a positive impact on the health and wellbeing of millions of Americans.”

Cognetivity plans to execute a vigorous business development strategy to achieve US-wide commercial rollout, including the establishment of regional outposts in the coming months. This will build on the company’s existing networks and recent successes in being selected to join two of the most prestigious and competitive accelerator programs in the US: the TMCx Innovation Accelerator at the Texas Medical Center – the largest medical city in the world – and Plug and Play’s Silicon Valley Health Batch 13.

While FDA registration is critical for US commercial rollout specifically, it also has advantages for Cognetivity’s plans in other parts of the world. “The benefits of reaching this milestone will extend far beyond the US itself,” Dr Habibi explained. “The FDA is the global exemplar in medical regulation; its name carries great weight all over the world. Without a doubt, this will bolster our regulatory and commercial efforts in other international jurisdictions as we continue to pursue our ambitions for deployment on a truly global scale.”