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Verisante Technology, Inc. Announces Milestone Completion of Coreā„¢ Commercial Prototype for the Detection of Lung Cancer


May 13, 2014 at 1:30 pm

COMPLETES RECERTIFICATION OF ISO CERTIFICATE OF QUALITY MANAGEMENT
SYSTEM FOR MEDICAL DEVICE MANUFACTURING

VANCOUVER, BRITISH COLUMBIA - Verisante Technology, Inc. (TSX-V: VRS, OTCQX: VRSEF) (the “Company” or “Verisante”), a leader in cancer detection technology, announced today that the Company has completed the development of the Core™ Series commercial prototype to aid in the detection of lung cancer.

The Core™ system, which is based on the same platform technology as Verisante’s award winning Aura™ device for the detection of skin cancer, will be used to prepare for the Company’s application for Regulatory Approval in Canada, Europe, USA and China for the lung cancer indication.

A clinical study on lung cancer using the Core™ technology has been completed and the Investigators of the study are currently preparing a paper for publication.  Previously published results showed that the device can measure the difference between low grade and high grade dysplasia, as well as carcinoma in situ. 

Core™, for lung cancer detection, employs an endoscopic probe that can be used in bronchoscopy procedures to help analyze lesions for malignancy.  A bronchoscopy is normally performed by a doctor under local anaesthetic to look for abnormal tissue and to take tissue samples, (or biopsies) if necessary.  The Core™ probe enters through the biopsy channel of the bronchoscope and measures the Raman spectra of the abnormal tissue, providing immediate feedback of the results of the spectral measurement to the doctor.  The probe is an endoscopic accessory that will fit with all major brands of endoscopes.  It will also be equipped with a consumable sheath to be discarded after each procedure.

In the United States, more than 500,000 bronchoscopies are performed annually to diagnose lung disease, and the American Cancer Society estimates the number of new cases of lung cancer diagnosed will be more than 224,000 in 2014.

In addition to the USA, Verisante anticipates one of the other major markets for Core™ for lung cancer will be China, where bronchoscopies are already widely performed.  According to the World Health Organization’s World Cancer Report 2014, 1.59 million people died from lung cancer globally in 2012, and China, with approximately 20 percent of the world’s population, accounted for more than one third of those deaths.

Lung cancer is the leading cause of cancer related deaths worldwide in both men and women, and has recently surpassed heart disease as the leading cause of smoking-related mortality.  More people die from lung cancer than breast cancer, colorectal cancer and prostate cancer combined. 

Verisante also has exclusive worldwide rights to the Core™ technology for the detection of gastro-intestinal, colorectal and cervical cancers by utilizing the same hardware with different diagnostic algorithms.  In addition, the Company has an option to license the exclusive rights for nasopharyngeal cancer.  Clinical studies are currently underway for nasopharyngeal and colon cancers, with more studies in the planning stages.

“Seeing the Core™ device for lung cancer detection come to life is a major milestone for Verisante.  We are now one step closer to getting this product in front of patients around the world.” said Thomas Braun, President & CEO.  “The purpose of the Core™ is to help save lives and save money for the health care system through assisting in the early detection of cancers and pre-cancers.”

To view photos of Core™, visit the Company’s facebook page at www.facebook.com/verisante

ISO Recertification of Quality Management System for Medical Device Manufacturing

The Company also announced today that it has successfully completed the re-certification process for ISO 13485:2003, an internationally recognized quality management standard.   Verisante was originally ISO certified in 2011 and requires re-certification every three years.  The re-certification is a confirmation of the Company's ability to design and manufacture medical devices.

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 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. 

Verisante Aura™ was awarded 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.  Verisante 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. 

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.

 

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