TMCnet News
Verisante Technology, Inc. Announces Submission to the FDA for Aura(TM), a Skin Cancer Detection Device(Marketwire Via Acquire Media NewsEdge) VANCOUVER, BRITISH COLUMBIA -- (Marketwired) -- 10/01/14 -- Verisante Technology, Inc. (TSX VENTURE: VRS)(OTCQX: VRSEF) (the "Company" or "Verisante"), a leader in cancer detection technology, announced today it has initiated communications with the Food and Drug Administration ("FDA") in the United States for the approval of Aura™, a device for the detection of skin cancer. "Verisante has now submitted documents to the FDA as we begin the formal application process for approval to market and sell Aura™ in the United States," said Thomas Braun. "We look forward to working closely with the FDA to receive further guidance and feedback on our regulatory pathway." According to the Skin Cancer Foundation, skin cancer is the most common form of Cancer in the United States, with more than 3.5 million skin cancers in over two million people diagnosed annually. Every year the new cases of skin cancer are greater than the incidences of breast, prostate, lung and colon cancer combined. Melanoma, the deadliest form of skin cancer, accounts for one death every 57 minutes in the United States. The overall 5-year survival rate for a patient whose melanoma is detected early, before the tumor has spread, is about 98 percent but falls to 62 percent when the disease reaches the lymph nodes, and 16 percent when the disease metastasizes to distant organs. About Aura™ Aura™ is a non-invasive Raman spectroscopy system designed to aid medical professionals in the detection of skin cancer. The system provides valuable information by identifying spectral changes associated with the biochemistry of skin cancer cells in less than a second; providing immediate results. Jointly developed by the BC Cancer Agency and the University of British Columbia Faculty of Medicine, this patent protected technology has already been used in a human clinical study spanning six years. Clinical results published in 2012 showed the technology offers a statistically significant improvement in the detection of skin cancer over current methods. Aura™ is currently approved for sale in Canada, Europe and Australia. About Verisante Technology, Inc. Verisante is a medical device company committed to commercializing innovative systems for the early detection of cancer. Verisante's Aura™ for skin cancer detection and Verisante's Core™ series for lung, GI tract 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 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. Aura™ has been approved for sale in Canada, Europe and Australia. Core™ has not yet been approved for sale. Aura™ was awarded the 2014 North American Technology Innovation of the Year Award for In Vivo Cancer Detection by Frost & Sullivan, Popular Science Magazine's "Best of What's New Award" for 2011, awarded a 2013 Prism Award for Innovation in Photonics and an Edison Award for Excellence in Innovation in 2013. Core™ was named one of the top 10 cancer breakthroughs of 2011 by the Canadian Cancer Society. 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. 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. Contacts: Verisante Technology, Inc. Thomas Braun President & CEO (604) 605-0507 [email protected] www.verisante.com YouTube: www.youtube.com/verisante Twitter: www.twitter.com/verisante Facebook: www.facebook.com/verisante Source: Verisante Technology, Inc. |