Verisante Technology, Inc. (TSX VENTURE:VRS)(OTCQX:VRSEF)(PINK
SHEETS:VRSEF)(FRANKFURT:V3T) (the "Company" or "Verisante"), a
leader in cancer imaging technology, announced today that it has
received notification of conformity to the European Medical Device
Directive, allowing sales of Verisante Aura(TM) in Europe.
"Obtaining a CE Mark allows us access to a market of over 21,000
dermatologists and 500 million people," said Verisante President
and CEO Thomas Braun. "2011 has been a breakthrough year for
Verisante. With Canadian and now European approval, the Company
continues to meet all of our commercialization milestones for
Verisante Aura(TM) as we move closer to bringing this innovative,
life-saving technology to market."
The Conformite Europeenne (CE) Mark approval is recognized by
all the 27 Member States of the EU and by Australia through a
reciprocity agreement. Verisante intends its initial launch in the
EU to begin in Germany, Austria and Switzerland, where distribution
channels will be placed to support sales and marketing efforts.
The European medical device market is the second largest in the
world, worth over $78 billion and representing 30 per cent of the
world market - second only to the United States. Within the EU, the
largest markets are Germany, UK, France, Italy, and Spain. These
five countries make up 60 per cent of the total EU population,
account for more than 70 per cent of the total EU GDP, and
approximately 80 per cent of the EU medical device market. With an
aging population and several new members in central Europe, the EU
medical market continues to grow. One of its fastest-growing
segments is the field of cancer diagnosis and treatments.
In Germany the incidence of skin cancers has tripled since 1980
and is about 20 per cent higher than the rest of Europe, with
melanoma accounting for 2,217 deaths each year. With a population
of 80 million, Germany also offers a reimbursement of 150 Euro
under their state health insurance which covers skin cancer
screenings every two years for people age 35 and older.
"Verisante Aura(TM) is a unique tool that can assist doctors in
the efficient diagnosis of skin cancers," said Dr. Harvey Lui, MD,
FRCPC, Director of the Skin Care Centre at Vancouver General
Hospital, Dermatologic Oncologist at the BC Cancer Agency,
Professor and Head, Department of Dermatology and Skin Science,
University of British Columbia, and one of the inventors of the
Aura(TM).
"With the rising incidence of all types of skin cancers,
innovative tools such as the Aura(TM), which can potentially be
used by general practitioners to evaluate suspicious skin lesions
quickly and accurately, will become increasingly important to the
heathcare system," said Dr. Lui.
The study used to support the CE Mark application was a six year
clinical study completed at the Skin Care Centre at Vancouver
General Hospital, where Verisante Aura(TM) was used to collect data
on over 1,000 lesions.
Early detection is key to saving the lives of melanoma patients
and saving healthcare costs. When melanoma is diagnosed and treated
in the earliest stages, the survival rate is 99 per cent and it
costs about $1,800 to treat it. In the late stages, the survival
rate decreases to 15 per cent, while the cost to treat it increases
to $170,000.
Verisante Aura(TM) is indicated for use for the evaluation of
skin lesions that may be clinically suspicious for melanoma,
squamous cell carcinoma and/or basal cell carcinoma when a medical
professional chooses to obtain additional information to rule out
one of the above conditions before making a final decision to
biopsy. Basal cell and squamous cell skin cancers together make up
about 96 per cent of all skin cancers. While early detection of
melanoma is critical due to its high mortality rate, it is also
important to detect the most common skin cancers early in order to
achieve the best results for patients.
Aura(TM) is a non-invasive optical system designed as a tool to
aid medical professionals in the assessment of suspect skin lesions
for diagnosis as either skin cancer or a benign disorder in less
than two seconds. The device uses Raman spectroscopy to
biochemically analyze the skin, providing immediate and accurate
results. The Aura(TM) will help to automate the current process of
diagnosis, allowing rapid scanning of the 20 to 40 skin lesions on
at-risk individuals, improving patient outcomes and comfort.
The Company will also now register Aura(TM) with the
Therapeutics Goods Administration in Australia.
About Verisante Technology, Inc.
Verisante is a medical device company committed to
commercializing innovative systems for the early detection of
cancer. The Verisante Aura(TM) for skin cancer detection and the
Verisante Core(TM) series for lung, colon and cervical cancer
detection utilize a proprietary cancer detection platform while the
operating software and probe technology are unique to each device.
The cancer detection platform was developed by the BC Cancer Agency
and tested and refined on approximately 1,000 lesions at the Skin
Care Centre at Vancouver General Hospital. This exclusive platform
technology allows Verisante to develop and offer a range of
compact, non-invasive cancer detection devices that offer
physicians immediate results for many of the most common cancers.
The Core(TM) has not yet been approved for sale.
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Forward-Looking Statements
This release contains forward-looking statements, including, but
not limited to, statements regarding the future commercialization
of medical devices, the market demand for these products and the
proprietary protections the Company will obtain with regard to the
technology, all of which statements are subject to market risks,
and the possibility that the Company will not be able to obtain
patent protection or obtain sufficient customer demand. These
statements are made based upon current expectations and actual
results may differ from those projected due to a number of risks
and uncertainties.
The TSX Venture Exchange has neither approved nor disapproved of
the contents of this press release. Neither the TSX Venture
Exchange nor its Regulation Services Provider (as that term is
defined in the policies of the TSX Venture Exchange) accepts
responsibility for the adequacy or accuracy of this press
release.
Contacts: Verisante Technology, Inc. Thomas Braun President
& CEO (604) 605-0507info@verisante.comwww.verisante.com
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