CE Mark for Verisante Aura™ Opens Doors to Massive European Market
November 9, 2011 at 7:00 am
APPROVAL WILL PROVIDE THE INNOVATIVE, LIFE-SAVING SKIN CANCER DETECTOR ACCESS TO A
$78 BILLION EUROPEAN MEDICAL DEVICE MARKET AND 27 EU MEMBER STATES
VANCOUVER, BRITISH COLUMBIA - Verisante Technology, Inc. (TSX-V: VRS, OTCQX: 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™ 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™ 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™ 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™.
“With the rising incidence of all types of skin cancers, innovative tools such as the Aura™, 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™ 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™ 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™ 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™ 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™ 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™ for skin cancer detection and the Verisante Core™ 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™ has not yet been approved for sale.
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.
Company Contact:
Thomas Braun, President & CEO
Verisante Technology, Inc.
Telephone: (604) 605-0507
Email: info@verisante.com
Website: www.verisante.com
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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.
