Cognetivity Neurosciences (CSE: CGN) has reached a major achievement. The company has been granted FDA clearance from the US Food and Drug Administration for the distribution of its integrated cognitive assessment. The approval essentially enables the company to market its device for use within the US market.
The granting of FDA clearance follows the CognICA Integrated Cognitive Assessment meeting the regulations for a Class II Exempt Medical Device and the approval of the firms associated submission for such exemption. The firm, with the clearance, now has access to the US$3.8 trillion healthcare market within the US, the largest such market globally.
Following the approval, Cognetivity this morning commented that it intends to conducted a “vigorous business development strategy” for commercial rollout across the US. The strategy is said to include regional outposts to build upon the firms existing networks due to accelerator programs it has participated in within the country.
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Speaking specifically to the Alzheimer’s and dementia market within the US, the niche is estimated to amount to a US$355 billion market in 2021, and accounts for a significant portion of the overall healthcare market. The result, is that the company anticipates strong demand for its tool geared towards the early detection of Alzheimer’s and dementia.
The tool itself consists of a five minute cognitive assessment that takes place on an iPad. The test is said to be highly sensitive to early signs of dementia, and is simplistic in nature, containing no cultural or educational bias. The test can also be delivered remotely due to its digital nature, enabling a cost effective means of early detection that can be conducted without practitioner supervision.
“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,” commented CEO Dr Sina Habibi on the major development for the company.
Cognetivity Neurosciences last traded at $0.70 on the CSE.
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