Devices will be used for clinical trials and Chinese FDA Approval
NORCROSS, Ga.–(BUSINESS WIRE)–#cervicalcancer–Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and
painless testing platform based on its patented biophotonic technology,
announced today that it has shipped five LuViva devices and associated
disposables to Shandong Yaohua Medical Device Technology Co., Ltd in
China. The devices will be used for clinical trials and laboratory
testing necessary for obtaining Chinese Food and Drug Administration
Shandong Yaohua Medical Device Company will conduct the necessary
clinical trials starting this year with the target of applying to the
CFDA before the end of 2017. If all goes according to plan, sales and
marketing could begin in 2018. In addition to paying for the clinical
trial and submission to CFDA, Shandong Medical will provide for the
distribution and sale of LuViva within China using its established
distribution and sales network.
China is potentially the world’s largest market for cervical cancer
screening with over 390 million women in the recommended ages for
screening. The incidence of cervical cancer in China is currently the
highest in the world and increasing. Increased screening for cervical
cancer is key to mitigating the losses associated with this disease.
“We are gratified that the level of cooperation between our two
companies has allowed us to make significant progress toward entering
the Chinese market with LuViva,” said Gene Cartwright, CEO and President
of Guided Therapeutics.
Added Li Yaohua, Chairman of Shandong Yaohua, “We are happy that our
plan for bringing LuViva to China has gotten off to a good start and are
optimistic regarding the future success of this important program, which
we believe will improve the healthcare of women by the earlier detection
of cervical cancer, when it is most treatable.”
About Shandong Yaohua Medical
Shandong Yaohua Medical Instrument Corporation, traded on the Chinese
National Equities Exchange and Quotations as 833141, is the maker and
distributor of medical devices and disposables for urine analysis, urine
test strips, vacuum blood collection tubes and other medical products.
They manufacture, distribute and sell to the domestic market in China,
the Middle East and Eastern Asia. Shandong Yaohua Medical Instrument
Corporation is located in the high-tech development zone of Shandong
Province, where it owns an 86,600 square meter production facility with
20,000 square meters of floor space dedicated to the high tech
manufacture of medical devices. Total revenue in 2015 for all Shandong
Yaohua holdings was approximately 87 million RMB ($12.7 million USD).
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCQB: GTHP) 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.
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 commercialization of products, 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 prior financings and the
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, 2015
and subsequent filings.
Bill Wells, 770-242-8723