Guided Therapeutics Reports New Progress with Chinese FDA and Increased Sales Forecast from Shandong Medical Device Technology Company

NORCROSS, Ga.–(BUSINESS WIRE)–#cervicalcancer–Guided Therapeutics, Inc. (Pink Sheets: GTHP), the maker of a rapid and
painless testing platform based on its patented biophotonic technology,
announced that it had received a new communication regarding regulatory
approval of its LuViva line of products in China. According to the
Company’s partner and distributor for China, Shandong Yaohuo Medical
Device Technology Company, Ltd., the Chinese FDA will request a
relatively small clinical trial in China of 60 to 120 patients, to be
conducted at two hospitals. The study is expected to begin this summer
and be completed within three months, after which Shandong will file
final paperwork for approval. In addition, LuViva was featured at
China’s largest biotech investment conference, the 5th BFC
Healthcare Investment Conference held in Shanghai on May 15-17, 2019.
After the conference, Shandong reported that it had signed several new
sub-distributors for China and that LuViva had placed 16th
out of the 100 best investments in a poll of conference participants. As
a result, Shandong has revised its forecast next year upward to include
orders of 300 LuViva devices and 3 million disposable Cervical Guides.

“Significant progress is being made on both the regulatory and
commercial fronts for LuViva in China, which is likely our largest
market given the size of the population and clinical need,” said Gene
Cartwright, CEO of Guided Therapeutics. “We look forward to working with
Shandong and the Chinese FDA to bring better healthcare to the women of
this vast and important country.”

According to the World Health Organization, cervical cancer is ranked as
one of the most frequent cancers in women in the world and in China it
is the second most common cancer among women. China has a population of
approximately 560 million women above 15 years of age, who are at risk
of developing cervical cancer. Current estimates indicate approximately
100,000 new cases of cervical cancer are diagnosed each year and 30,000
deaths occur annually due to cervical cancer in China.

About Guided Therapeutics

Guided Therapeutics, Inc. (Pink Sheets: 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. 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 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, 2017
and subsequent filings.


Mark Faupel
Guided Therapeutics

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