Cambridge Cognition Holdings PLC US regulatory clearance for CANTAB Mobile (0059V)
25 January 2017 - 6:00PM
UK Regulatory
TIDMCOG
RNS Number : 0059V
Cambridge Cognition Holdings PLC
25 January 2017
25 January 2017
Cambridge Cognition Holdings Plc
('Cambridge Cognition' or the 'Company')
Cambridge Cognition awarded US regulatory clearance for CANTAB
Mobile
The neuroscience digital health company Cambridge Cognition
Holdings PLC (Cambridge, UK - LSE: COG) has announced it has
received 510(k) clearance from the U.S. Food and Drug
Administration ('FDA') to market its CANTAB Mobile product as a
medical device in the U.S.
CANTAB Mobile is designed to detect clinically-relevant memory
impairment in older adults at the point of care. It includes a
computerised test of visuospatial associative learning (CANTAB PAL)
to assess episodic memory with optional mood and functional
assessments, which can help to detect symptoms of depression and
problems with performing regular activities of daily living.
The touchscreen test, which takes under 10 minutes to complete,
can be self-administered using voiceover instructions in over 20
languages with automatic scoring, accounting for age, gender and
education level. All results can be accessed in a simple to
interpret, one-page physician's report using a traffic-light output
for memory and mood outputs.
Since being classified as a European Medical Device in 2013,
CANTAB Mobile has been used routinely to assess over 26,000
patients in the UK who had concerns about their memory or were
considered by their physician to be at increased risk of dementia.
The test is based on 30 years of research into Alzheimer's disease
and over 500 peer-reviewed papers including independent studies
demonstrating how the CANTAB Mobile memory assessment is sensitive
to detecting the earliest signs of prodromal Alzheimer's disease
years before a clinical diagnosis(1) .
The 510(k) clearance for CANTAB Mobile allows Cambridge
Cognition to market the medical device for commercial distribution
in the U.S. where significant interest in the product has developed
among primary and secondary care organisations and corporate health
providers.
Dr Steven Powell, Chief Executive Officer, Cambridge Cognition,
commented: "There is a great unmet need for effective near patient
assessment tools to assess memory impairment. CANTAB Mobile is an
established and proven digital health product and we are delighted
to announce the 510(k) clearance. Access to the large US healthcare
market combined with the recent investment in our U.S. operation
will help underpin the Company's revenues and its continued
growth."
(1)
Swainson, R., Hodges, J.R., Galton C.J., Semple, J. Michael A.,
Dunn B.D., ...Sahakian B.J. (2001). Early detection and
differential diagnosis of Alzheimer's disease and depression with
neuropsychological tasks. Dementia & Geriatric Cognitive
Disorders, 12, 265-280.
Fowler, K.S., Saling, M.M., Conway, E.L., Semple, J.M. &
Louis, W.J. (2002). Paired associate performance in the early
detection of DAT. Journal of the International Neuropsychological
Society, 8, 58-71.
Blackwell, A.D., Sahakian, B.J, Vesey, R., Semple, J.M.,
Robbins, T.W. & Hodges, J.R. (2004). Detecting dementia: novel
neuropsychological markers of preclinical Alzheimer's disease.
Dementia & Geriatric Cognitive Disorders, 17, 42-48.
Notes to editors
About Cambridge Cognition Holdings PLC
Cambridge Cognition is a neuroscience digital health company
specialising in the precise measurement of clinical outcomes in
neurological disorders. The Company develops and markets validated
near patient assessment products using cognition as a biomarker to
improve understanding, diagnosis and treatment in brain health
worldwide.
Partners include the world's leading drug development companies,
academic institutions and public-private health organisations.
www.cambridgecognition.com @CANTABconnect press@camcog.com
Enquiries
Cambridge Cognition Holdings PLC
Steven Powell, Chief Executive Tel: 01223 810
Officer 700
Noah Konig, Director of Marketing press@camcog.com
and Communications
finnCap Ltd (NOMAD and Joint Broker) Tel: 020 7220
Geoff Nash / Simon Hicks 0500
Alice Lane (Corporate Finance)
(Corporate Broking)
Hybridan LLP (Joint Broker) Tel: 020 3764
2341
Claire Noyce (Corporate Broking)
This information is provided by RNS
The company news service from the London Stock Exchange
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January 25, 2017 02:00 ET (07:00 GMT)