Guided Therapeutics Targeting Large Cervical Cancer Screening Markets with LuViva® Advanced Cervical Scan with New Single-Patient-Use Disposable
Up to two billion women in the developing world could benefit from
quick, painless, high-tech scan
NORCROSS, Ga.–(BUSINESS WIRE)–Guided Therapeutics, Inc. (OTCQB: GTHPD), the maker of a rapid and
painless testing platform based on its patented biophotonic technology,
announced today that the company is now shipping a new screening version
of its single-use disposable Cervical Guide designed to make the product
accessible to the approximately 2.0 billion women at risk for cervical
cancer in the developing world.
Screening for cervical cancer offers one of the largest opportunities
available in diagnostic medicine. A woman becomes “at risk” for cervical
cancer after becoming sexually active. Cervical cancer is linked to a
sexually transmitted disease — human papillomavirus (HPV). In the
developing world there are approximately 2.0 billion women aged 15 and
older who are potentially eligible for screening with LuViva.
Screening for cervical cancer in the developing world also presents the
opportunity to work with governments. Partnering with governments can
provide immediate access to large numbers of lives covered under
national or regional governmental healthcare programs.
“Our new screening Cervical Guide, one of which is used with each
patient, is designed to cost less to ship, take up less storage space
and produce less waste,” said Gene Cartwright, CEO and president of
Guided Therapeutics, Inc. “We will be rolling out the new Cervical
Guides in the coming months in countries where we are actively working
with distributors to implement government-sponsored screening programs —
Turkey, Bangladesh, Indonesia, Kenya and Nigeria. The number of
screening candidates in those countries is approximately 246 million and
represents three of the 10 most populous countries in the world.”
Worldwide, the market for cervical cancer screening and diagnostics, as
currently practiced using cytology (Pap test) for primary screening, is
estimated at $6 billion and is projected to grow to almost $9 billion by
2020. Including the developed countries, there are about 2.6 billion
women aged 15 years and older who are at risk of developing cervical
cancer worldwide.
Internationally, the company has regulatory approval to sell LuViva in
Europe upon receipt of our Edition 3CE Mark in January 2014. LuViva has
marketing approval from Health Canada, COFEPRIS in Mexico, Ministry of
Health in Kenya and the Singapore Health Sciences Authority.
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 may result in eliminating costly, painful and
unnecessary additional testing. LuViva is intended 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. It has also been used in clinical studies in
Turkey and Nigeria as a means to screen women for cervical cancer where
the availability of infrastructure necessary for Pap and HPV testing is
restricted. The device is used in conjunction with the LuViva®
Cervical Guide single-use patient interface and calibration disposable.
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCQB: GTHPD) is the maker of a rapid and
painless testing platform based on its patented biophotonic technology
that utilizes light for the early detection of disease at the cellular
level. The Company’s first 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. For more information, visit: www.guidedinc.com.
The Guided Therapeutics LuViva® Advanced
Cervical Scan is an investigational device and is limited by federal law
to investigational use in the U.S. LuViva, the wave logo and “Early
detection, better outcomes” are registered trademarks owned by Guided
Therapeutics, Inc.
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 sufficiency of capital raised in our prior financings and
our ability to realize their expected benefits, the uncertainty of
future capital to develop products or continue as a going concern, the
uncertainty of regulatory approval of products, and the 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, including Guided Therapeutics’
Annual Report on Form 10-K for the fiscal year ended December 31, 2014
and subsequent filings.
Contacts
Investor and Media Relations Contact:
IRTH Communications
Robert
Haag, 866-976-4784
Managing Director
gthp@irthcommunications.com
or
Guided
Therapeutics
Bill Wells, 770-242-8723
