|[January 07, 2013]
Guided Therapeutics Successfully Completes Canadian Standard Association Requirements for LuViva® Advanced Cervical Scan
NORCROSS, Ga. --(Business Wire)--
Therapeutics, Inc., (OTCBB: GTHP) (OTCQB: GTHP), today announced
that it has successfully completed third-party testing of the LuViva®
Advanced Cervical Scan. This puts LuViva in compliance with Canadian
Standards Association (CSA®) requirements which, while not
required for marketing in Canada, are preferred by certain larger
medical institutions. It also puts the company one step closer to
applying the Edition 3 CE Mark to LuViva.
"The completion of CSA standards certification is an independent
validation of the safety and integrity of LuViva's design," said Mark L.
Faupel, CEO and President of Guided Therapeutics, Inc. "In addition to
further opening up the Canadian market, the certification documentation
can be used as a basis for obtaining regulatory approval and subsequent
sales in certain Latin American and Asian countries."
The testing for the certification was conducted in parallel with CE Mark
testing by SGS U.S. Testing Company, Inc. - a Nationally Recognized Test
Lab. LuViva will carry the SGS USTC Mark for both Canada and the U.S.
With all third-party testing complete, the remaining steps for the
Edition 3 CE Mark are to complete final mechanical tests and submit for
review final documentation, a process which is expected to take a few
weeks. Guided Therapeutics plans to then immediately apply the Edition 3
CE Mark to the LuViva in order to support its international product
launch in the first quarter of 2013.
LuViva currently has marketing approval from Health Canada and received
its first CE Mark, an ISO 60601 Edition 2 Notification, in July. Guided
Therapeutics was awarded ISO 13485 certification in January 2011.
Additionally, LuViva has been unde U.S. Food and Drug Administration
Premarket review since September 23, 2010. After meetings with the FDA,
the Company filed an amended PMA application with the agency in November
About LuViva® Advanced Cervical Scan
LuViva is a technologically advanced diagnostic device that scans the
cervix with light and uses spectroscopy to measure how light interacts
with the cervical tissue. Spectroscopy identifies chemical and
structural indicators of precancer that may be below the surface of the
cervix or misdiagnosed as benign. This technique is called biophotonics.
Unlike Pap, HPV tests or biopsies, LuViva does not require laboratory
analysis or a tissue sample, and is designed to provide results
immediately, which eliminates costly, painful and unnecessary testing.
LuViva is designed for use with women who have undergone initial
screening and are called back for follow up with a colposcopy
examination, which in many cases, involves taking a biopsy of the
cervix. The device is used in conjunction with the LuViva®
Cervical Guide single-use patient interface and calibration disposable.
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) is developing a
rapid and painless testing platform for the early detection of disease
based on its patented biophotonic technology that utilizes light to
detect disease at the cellular level. The Company's first planned
product is the LuViva® Advanced Cervical Scan, a non-invasive
device used to detect cervical disease instantly and at the point of
care. In a multi-center clinical trial, with women at risk for cervical
disease, the technology was able to detect cervical cancer up to two
years earlier than conventional modalities, according to published
reports. Guided Therapeutics has also entered into a partnership with
Konica Minolta (News - Alert) to develop a non-invasive test for the early detection of
esophageal cancer using the technology platform. For more information,
The Guided Therapeutics LuViva® Advanced
Cervical Scan is an investigational device and is limited by federal law
to investigational use. LuViva, the wave logo and "Early detection,
better outcomes" are registered trademarks owned by Guided Therapeutics,
CSA® is a registered trademark of the Canadian Standards Association.
Forward-Looking Statements Disclaimer: A number of the matters and
subject areas discussed in this news release that are not historical or
current facts deal with potential future circumstances and developments.
The discussion of such matters and subject areas is qualified by the
inherent risks and uncertainties surrounding future expectations
generally and also may materially differ from Guided Therapeutics'
actual future experience involving any of or more of such matters and
subject areas. Such risks and uncertainties include those related to the
early stage of products in development, the uncertainty of market
acceptance of products, the uncertainty of development or effectiveness
of distribution channels, the intense competition in the medical device
industry, the uncertainty of capital to develop products, the
uncertainty of regulatory approval of products, dependence on licensed
intellectual property, as well as those that are more fully described
from time to time under the heading "Risk Factors" in Guided
Therapeutics' reports filed with the SEC (News - Alert), including Guided Therapeutics'
Annual Report on Form 10-K for the fiscal year ended December 31, 2011,
and subsequent quarterly reports.
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