Medicsight receives FDA clearance for ColonCAD (8760G)
19 Mai 2011 - 8:00AM
UK Regulatory
TIDMMDST
RNS Number : 8760G
Medicsight Plc
19 May 2011
Press Release 19 May 2011
Medicsight PLC
("Medicsight" or "the Company")
FDA 510(k) Clearance to market ColonCAD(TM) API in the United
States
Sales and commercialisation channels for ColonCAD now open
Medicsight PLC (AIM: MDST), an industry leader in the
development of Computer-Aided Detection (CAD) and medical image
analysis software is pleased to announce that the Medicsight
ColonCAD(TM) API has received clearance from the U.S. Food and Drug
Administration (FDA). The clearance enables Medicsight to implement
its US sales and marketing strategy, a primary objective in the
development of the business since flotation.
Medicsight's ColonCAD is designed to assist radiologists during
their review of CT colonography (CTC - also known as "Virtual
Colonoscopy") images by automatically highlighting potential
colorectal polyps (possible precursors to colorectal cancer) on the
CT image. The FDA clearance was supported by a large clinical trial
involving 15 radiologist readers who each reviewed 112 patient CT
colonography cases both unassisted and assisted by ColonCAD.
ColonCAD was used to support their evaluation after they had made
an initial review of all the CTC image data. Cases were from a
mixture of symptomatic and asymptomatic patients. The clinical
trial results demonstrated that, when assisted by ColonCAD,
radiologists' accuracy for detecting polyps of all sizes was
significantly improved compared with unassisted reading.
Professor Steve Halligan of University College Hospital in
London, the Principal Investigator for the trial, commented "The
supporting clinical study clearly demonstrates the positive effect
of Medicsight's ColonCAD on the performance of radiologists, and I
believe that the results show the true potential of computer aided
detection as a tool which will provide significant benefit in
clinical practice around the world."
Allan Rowley, CEO of Medicsight, said "We are absolutely
delighted to have reached this important milestone for Medicsight
and are excited about receiving FDA clearance for ColonCAD(TM) API
at a time when we anticipate that the demand for Virtual
Colonoscopy and CAD will rapidly increase. We look forward to the
commercialisation of Medicsight ColonCAD in the United States
through our network of advanced visualisation partners who are
ready to deliver the ColonCAD solution to end users. I would also
like to thank the whole Medicsight team for their commitment to the
project, and bringing us to this key juncture."
Professor Perry Pickhardt from the University of Wisconsin
School of Medicine & Public Health, said "Having experienced
the potential of Medicsight's ColonCAD in a research environment I
am very excited that the product will now be available for clinical
use in the US. I believe that ColonCAD will provide a real benefit
and have a positive impact on radiologists' review of virtual
colonoscopy images."
CT colonography is a minimally invasive examination that
captures digital images of the patient's colon and generates
detailed three-dimensional digital images of the entire colorectum
- enabling radiologists to thoroughly review the entire colon area.
Virtual Colonoscopy can be used for colon screening and also for
the investigation of symptoms of colonic disease.
In comparison to an optical colonoscopy examination, a Virtual
Colonoscopy has the benefits of: (a) being much less invasive; (b)
has no requirement for intravenous sedation or pain medication; and
(c)requires no recovery time. With only half of the 100 million
qualifying Americans aged fifty and over undergoing a colon cancer
screening test, the availability of tests that improve patient
compliance is of vital importance, and tools like Virtual
Colonoscopy with Medicsight's ColonCAD that improve test
performance, are likely to be of significant benefit to patient
care and helping reduce colorectal cancer.
- ENDS -
For further information:
Medicsight plc
Allan Rowley, CEO Tel: +44 (0)207 605 7950
www.medicsight.com
follow us on twitter
@Medicsight
Daniel Stewart & Co
Noelle Greenaway / Oliver Rigby Tel: +44 (0) 207 776 6550
www.danielstewart.co.uk
Media enquiries:
Abchurch
www.abchurch-group.com
Julian Bosdet Tel: +44 (0) 207 398 7700
julian.bosdet@abchurch-group.com
Adam Michael Tel: +44 (0) 207 398 7708
adam.micheal@abchurch-group.com
Simone Elviss Tel: +44 (0) 207 398 7728
simone.elviss@abchurch-group.com
Quincy Allan Tel: +44 (0) 207 398 7710
quincy.allan@abchurch-group.com
Notes to editors
Medicsight plc is a UK-headquartered, research driven, leading
developer of computer-aided detection (CAD) and image analysis
software for the medical imaging market. The CAD software
automatically highlights suspicious areas on computerised
tomography (CT) scans of the colon, helping radiologists to
identify, measure and analyse potential disease and early
indicators of disease. Medicsight's CAD software has been developed
using a large and population diverse database of verified patient
CT scan data. Medicsight's ColonCAD(TM) software products are
seamlessly integrated with the advanced 3D visualisation
workstations of several industry-leading imaging equipment
partners.
About Computer-Aided Detection
With increasingly sophisticated radiological imaging hardware
such as Multi-Detector CT scanners, radiologists are facing a
growing challenge in the amount of detailed patient image data that
they must review for each patient examination. Some CT scan
examinations generate as many as 2000 images per patient. Review of
this data by the radiologist is not only time-consuming but also
prone to error due to reader fatigue. CAD software can help the
reviewing radiologist by analysing the image data and automatically
highlighting suspicious regions of interest for closer inspection.
Without CAD software some potential abnormalities or areas of
disease may be overlooked. This can be critical for diagnosis and
the management of patient outcomes as early detection of disease
greatly increases the probability of successful treatment and a
positive therapeutic outcome. In addition to supporting individual
radiologists CAD also has the potential to help standardise CT
interpretation across both individuals and institutions thereby
supporting population based screening programmes.
About Medicsight's CAD software
Medicsight's ColonCAD(TM) software uses an advanced CAD
algorithm to analyse CT scans of the colon and automatically
highlight suspicious areas that may be indicators of disease. CAD
may highlight areas easily overlooked by the reviewing radiologist,
such as small lesions or regions that are hidden from view behind
folds in the colon.
ColonCAD can be seamlessly integrated with advanced 3D
visualisation platforms of industry-leading imaging equipment
partners. The integrated systems provide sophisticated image
viewing capabilities, including 3D reconstructed image data, with
the added advantage of demonstrating automatic CAD findings to
assist clinical end users in the detection and analysis of
disease.
Since inception, Medicsight has developed close and lasting
relationships with some of the world's foremost clinicians in
product related areas. This provides the Company with a wealth of
clinical expertise and dedicated clinical research to support
ongoing product development. Medicsight also collaborates with a
number of leading academic institutions and clinical research
programmes worldwide to develop the Company's comprehensive
database of population diverse verified patient CT scan data, thus
allowing Medicsight's products to be validated to the highest
possible standards.
About colorectal cancer
According to the American Cancer Society, colorectal cancer is
one of the leading causes of cancer-related deaths in the United
States with an estimated 49,000 colorectal cancer deaths expected
during 2011. However regular screening (where polyps can be
detected at an early stage before they have developed into cancer)
is one of the most powerful methods of colorectal cancer
prevention. Screening for colorectal polyps increases the
probability of more colorectal cancers being detected earlier -
when the disease is easier to cure.
This information is provided by RNS
The company news service from the London Stock Exchange
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