Verisante Technology, Inc. Announces Milestone Completion of Core(TM) Commercial Prototype for the Detection of Lung Cancer
May 13 2014 - 9:29AM
Marketwired
Verisante Technology, Inc. Announces Milestone Completion of
Core(TM) Commercial Prototype for the Detection of Lung Cancer
Completes Recertification of ISO Certificate of Quality
Management System for Medical Device Manufacturing
VANCOUVER, BRITISH COLUMBIA--(Marketwired - May 13, 2014) -
Verisante Technology, Inc. (TSX-VENTURE: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.
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.
Verisante Technology, Inc.Thomas BraunPresident & CEO(604)
605-0507info@verisante.comwww.verisante.comYoutube:
www.youtube.com/verisanteTwitter:
www.twitter.com/verisanteFacebook: www.facebook.com/verisante
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