Share |
News

Verisante Starts FDA Approval Process and Provides Operational Update


December 22, 2011 at 7:00 am

 

2011 A BREAKTHROUGH YEAR FOR VERISANTE AURA 

VANCOUVER, BRITISH COLUMBIA - Verisante Technology, Inc. (TSX-V: VRS, OTCQX: 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:

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 also approval 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™ 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  
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. 

 

  Back to top