Verisante Issues Update on Regulatory Milestones
10/6/2011 10:00:05 AM - Market Wire
Files With Health Canada and Readies Application for CE Mark
VANCOUVER, BRITISH COLUMBIA, Oct 6, 2011 (Marketwire via COMTEX News Network) --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 filed an application with Health Canada for a Class II Medical Device License to market and sell Verisante Aura(TM), a non-invasive medical device for the detection of skin cancer, in Canada.
The Company has completed all applicable safety testing required under Health Canada guidelines. Additional safety testing is also being done to confirm compliance with European guidelines. This additional testing is required to complete the Technical File for submission to a notified body to receive CE Mark approval for Europe. Verisante anticipates submitting our Technical File in October.
"We have come a long way and have met many milestones since licensing this technology from the BC Cancer Agency only 15 months ago," said President and CEO Thomas Braun. "As we move into the final quarter of 2011, we remain confident we will be able to meet our regulatory milestones of Canadian, European, and Australian approval by the end of the year."
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.
SOURCE: Verisante Technology, Inc.
Verisante Technology, Inc. Thomas Braun President & CEO (604) 605-0507 info@verisante.com www.verisante.com
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