Cognetivity Neurosciences has received notification from the US Food and Drug Administration (FDA) that its 510(k) submission for the CognICA Integrated Cognitive Assessment (ICA) has been reviewed and found to meet the requirements of regulations 21 CFR 882.1470; 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, computerised cognitive assessment, delivered on iPad devices. 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 computerised 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 NHS. Registration with the FDA now grants Cognetivity access to the US healthcare market, which is the largest of any country in the world.
US national healthcare expenditure reached $3.8 trillion in 2019 and is estimated to rise to $6.2 trillion by 2028. Alzheimer's and other dementias make up a substantial proportion of that figure, costing the nation $355 billion in 2021, according to the Alzheimer's Association. That figure could grow to more than $1.1 trillion by 2050, by which time the number of Americans aged 65 and older living with Alzheimer's alone is expected to have more-than-doubled to 12.7 million. As such, there is enormous demand for improvements in the diagnosis and treatment of such conditions.
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 revolutionise 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 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 in being selected to join two competitive accelerator programs in the US: the TMCx Innovation Accelerator at the Texas Medical Center 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.
Dr Habibi explained: "The benefits of reaching this milestone will extend far beyond the US itself. The FDA is the global exemplar in medical regulation; its name carries great weight all over the world. Without a doubt, this mark of certification 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."
