Cambridge Cog Regulatory News (COG)

05 May 2016

Cambridge Cognition Holdings Plc

('Cambridge Cognition' or the 'Company')

Cambridge Cognition submits CANTAB Mobile for FDA clearance

The neuroscience technology company Cambridge Cognition Holdings PLC (Cambridge, UK - LSE: COG) has made a submission in respect of its CANTAB Mobile product to the Food and Drug Administration ('FDA') in the USA for 510(k) clearance as a medical device for use within an American healthcare market estimated to be worth in excess of $110 billion1.

The CANTAB Mobile product was developed to detect episodic memory impairments in early stage Alzheimer's disease patients aged over 50. Since its launch the product has been used to assess over 25,000 people in the UK since being classified as a European Class IIa Medical Device in 2013.

Having established a commercial team in the USA in 2015 to drive sales into its core Academic Research and Pharmaceutical Clinical Trials markets; the FDA submission marks the first step in broadening out the Company's healthcare technologies into the American market.

Today, 5.3 million Americans are living with Alzheimer's. By 2050, it is estimated that up to 16 million will have the disease2. The direct cost of caring for Alzheimer's patients in the United States is estimated to be $226 billion with half of the costs borne by Medicare2.

Despite the growing numbers of patients, it is estimated that fewer than 50% of Alzheimer's cases are recognised and documented in primary care3, something the scientists at Cambridge Cognition believe CANTAB Mobile could improve.

A series of independent studies has demonstrated that the memory assessment in CANTAB Mobile is sensitive to detecting the earliest signs of prodromal Alzheimer's disease up to three years before a clinical diagnosis (Swainson et al., 2001; Fowler et al., 2002; Blackwell et al., 2004). Such early detection could serve to maximize the potential therapeutic benefit of treatment, enhance patient quality of life and reduce the burden on residential and nursing care services.

Steven Powell, Chief Executive Officer, Cambridge Cognition: "Having demonstrated the clinical efficacy and feasibility of CANTAB Mobile within the UK National Health Service it is our intention to broaden the commercialisation of our healthcare products outside of Europe, particularly in the North American markets. Submission of the first Cambridge Cognition product for FDA clearance is a significant landmark as we continue to develop solutions to address this significant and growing market."

1 Select USA. The Medical Device Industry in the United States.http://selectusa.commerce.gov/industry-snapshots/medical-device-industry-united-states.html

2 Alzheimer's Association 2015 Alzheimer's Disease Facts and Figures.

3 Alzheimer's Disease International 2016.

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About Cambridge Cognition

Cambridge Cognition is a leading neuroscience and technology company delivering software and services to improve the understanding, diagnosis and treatment of mental health worldwide.

For over 30 years the Company's innovative CANTAB® technology has advanced the measurement of cognition in global scientific research; clinical trials; and general healthcare, accelerating the development of safe and effective treatments, reducing health service costs and improving patient outcomes.

In addition, the Company now develops a range of consumer focused digital health software products on mobile and wearable devices to help measure, manage and improve cognitive health throughout life.

Clients include the world's leading biotechnology and pharmaceutical companies; renowned academic institutions; and public-private healthcare providers.

For further information, visit www.cambridgecognition.com