Verisante Starts FDA Approval Process and Provides Operational Update
http://at.marketwire.com/accesstracking/AccessTrackingLogServlet?docid=0754873001&sourceType=1http://www.ccnmatthews.com/logos/20110201-Veri.gifVANCOUVER, BRITISH COLUMBIA -- (Marketwire) -- 12/22/11 -- Verisante Technology, Inc. (TSX VENTURE:VRS)(OTCQX:VRSEF)(PINKSHEETS:VRSEF)(FRANKFURT:V3T) (the "Company" or "Verisante"), a leader in skin cancer detection technology, has begun the process to obtain US Food and Drug Administration (FDA) approval for Verisante Aura. Verisante expects to have a pre-Investigational Device Exemption meeting with the FDA in the first quarter of 2012 to receive regulatory guidance.
"The Company has reached all of our major milestones this year," said Thomas Braun, Verisante President and CEO. "In addition to obtaining Health Canada and European approval for Verisante Aura, we have been able to garner significant media attention and industry awareness of our innovative products. Being a recipient of Popular Science magazine's Best of What's New award was a great endorsement of the Aura's breakthrough technology."
A summary of significant corporate highlights and achievements for 2011 include:
- A name change and rebranding of the Company, including a new logo and website.
- Research coverage initiated by Zacks Investment.
- Raising $6 million in private placement financings.
- Raising an additional $3.2 million through the exercise of stock options and warrants.
- Current cash balance of approximately $6 million.
- Obtained listings on the OTCQX and Frankfurt Stock Exchanges.
- Announced pilot study results for lung cancer detection system using the Verisante Core. The study demonstrated 96% sensitivity and 91% specificity, which set a new standard for lung cancer detection.
- Purchased 17 cancer imaging patents and the ClearVu and ClearVu Elite assets from Perceptronix Medical and in-licensing multispectral imaging technology developed by the BC Cancer Agency.
- Completed industrial design of Verisante Aura and engaged a contract manufacturer.
- Awarded ISO 13485:2003 certification as a medical device developer and manufacturer.
- Awarded Health Canada approval for the Aura.
- Awarded CE Mark for the Aura.
- Featured by more than a dozen major media outlets, including CNN and the National Post. All media coverage can be found on the Company's website.
- Verisante Aura awarded Best of What's New Award by Popular Science magazine.
- Received Australian registration for the Aura.
The academic paper on the statistical analysis completed by the University of British Columbia earlier this year is now awaiting acceptance for publication. Verisante will announce the results of the analysis once authorized to do so.
The Company has also increased the number of initial production units from 7 to 10, and Verisante is now completing the testing of the units. These initial devices will be used in field testing sites and post-market studies.
The Company has begun pre-marketing the Aura by exhibiting at various dermatology conferences. Verisante Aura will go into production and sales in the second half of 2012. The Company is currently selecting distributors and will first launch the Aura in Canada, Germany, Austria, Switzerland and Australia.
"There are 21,000 dermatologists in Europe and 5,500 dermatologists in Germany, which we think will be the most significant market in Europe," said Braun. "While we seek FDA approval, our CE Mark and Health Canada approval allow us to build our revenue in these other markets."
Health Canada approval also clears the way for the Company to register Verisante Aura for sale in Mexico and Brazil. Verisante has begun the registration process for these countries and expects to obtain Mexican registration in 2012 and Brazilian registration in 24 months.
Australia has one million consultations per year for skin cancer and Brazil has one of the highest rates of skin cancer in the world and a population of 193 million people.
"We now have access to markets where quick, accurate information to aid skin cancer diagnoses is absolutely essential," said Braun. "Early detection of skin cancer saves lives and saves dollars, making the Verisante Aura a compelling device for healthcare professionals and their patients."
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.
Youtube: www.youtube.com/verisante
Twitter: www.twitter.com/verisante
Facebook: www.facebook.com/verisante
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) 605-0507
info@verisante.com
www.verisante.com
"The Company has reached all of our major milestones this year," said Thomas Braun, Verisante President and CEO. "In addition to obtaining Health Canada and European approval for Verisante Aura, we have been able to garner significant media attention and industry awareness of our innovative products. Being a recipient of Popular Science magazine's Best of What's New award was a great endorsement of the Aura's breakthrough technology."
A summary of significant corporate highlights and achievements for 2011 include:
- A name change and rebranding of the Company, including a new logo and website.
- Research coverage initiated by Zacks Investment.
- Raising $6 million in private placement financings.
- Raising an additional $3.2 million through the exercise of stock options and warrants.
- Current cash balance of approximately $6 million.
- Obtained listings on the OTCQX and Frankfurt Stock Exchanges.
- Announced pilot study results for lung cancer detection system using the Verisante Core. The study demonstrated 96% sensitivity and 91% specificity, which set a new standard for lung cancer detection.
- Purchased 17 cancer imaging patents and the ClearVu and ClearVu Elite assets from Perceptronix Medical and in-licensing multispectral imaging technology developed by the BC Cancer Agency.
- Completed industrial design of Verisante Aura and engaged a contract manufacturer.
- Awarded ISO 13485:2003 certification as a medical device developer and manufacturer.
- Awarded Health Canada approval for the Aura.
- Awarded CE Mark for the Aura.
- Featured by more than a dozen major media outlets, including CNN and the National Post. All media coverage can be found on the Company's website.
- Verisante Aura awarded Best of What's New Award by Popular Science magazine.
- Received Australian registration for the Aura.
The academic paper on the statistical analysis completed by the University of British Columbia earlier this year is now awaiting acceptance for publication. Verisante will announce the results of the analysis once authorized to do so.
The Company has also increased the number of initial production units from 7 to 10, and Verisante is now completing the testing of the units. These initial devices will be used in field testing sites and post-market studies.
The Company has begun pre-marketing the Aura by exhibiting at various dermatology conferences. Verisante Aura will go into production and sales in the second half of 2012. The Company is currently selecting distributors and will first launch the Aura in Canada, Germany, Austria, Switzerland and Australia.
"There are 21,000 dermatologists in Europe and 5,500 dermatologists in Germany, which we think will be the most significant market in Europe," said Braun. "While we seek FDA approval, our CE Mark and Health Canada approval allow us to build our revenue in these other markets."
Health Canada approval also clears the way for the Company to register Verisante Aura for sale in Mexico and Brazil. Verisante has begun the registration process for these countries and expects to obtain Mexican registration in 2012 and Brazilian registration in 24 months.
Australia has one million consultations per year for skin cancer and Brazil has one of the highest rates of skin cancer in the world and a population of 193 million people.
"We now have access to markets where quick, accurate information to aid skin cancer diagnoses is absolutely essential," said Braun. "Early detection of skin cancer saves lives and saves dollars, making the Verisante Aura a compelling device for healthcare professionals and their patients."
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. Youtube: www.youtube.com/verisante
Twitter: www.twitter.com/verisante
Facebook: www.facebook.com/verisante
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) 605-0507
info@verisante.com
www.verisante.com
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