Guided Therapeutics Enters into LuViva® Advanced Cervical Scan Manufacturing and License Agreement for China
Deal includes equity investment in Guided Therapeutics and commitment
to fund all manufacturing start up, regulatory and distribution costs in
China
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 reached agreement with Shandong Yaohua
Medical Instrument Corporation in China for exclusive distribution,
sales and manufacturing rights of the LuViva® Advanced Cervical Scan for
China, Taiwan, Hong Kong and Macau.
In addition to a previous payment of $50,000 made by Shandong Yaohua,
the terms of the license agreement include a licensing fee by Shandong
Yaohua of $1,000,000, the purchase of a minimum of ten LuViva® Advance
Cervical Scan devices in 2017 and royalties for disposables based on
minimum orders once Chinese Food and Drug Administration (CFDA) approval
is obtained. To further align the strategic interests of the parties,
Guided Therapeutics has agreed to issue $1,000,000 in shares of its
common stock to Shandong Yaohua.
Shandong Yaohua will conduct the necessary clinical trials and apply to
the CFDA for approval to market LuViva in China. Once approved, Shandong
Yaohua will provide for the distribution and sale of LuViva within China
with 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.
Under the terms of the agreement, Shandong Yaohua will establish
manufacturing lines for LuViva within its existing medical device
manufacturing facilities, which will enable Shandong Yaohua to supply
Guided Therapeutics with LuViva products. With increased volume of
production, advanced manufacturing processes and competitive labor
rates, the Company expects that Shandong Yaohua will be able to lower
the costs for the LuViva device and disposables for the global market.
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. There are about 2.6 billion women aged 15 years and older who are
at risk of developing cervical cancer worldwide.
“We are pleased to be partnering with Shandong Yaohua to bring LuViva to
China and improve early detection in a market where cervical cancer,
often found too late, is the second leading killer among women’s
cancers,” said Gene Cartwright, CEO and President of Guided
Therapeutics. “The agreement also opens up the possibility to bring
efficiencies to our manufacturing processes as well as opening up
additional markets in East Asia.”
“LuViva is the ideal product to address this critical women’s health
concern, which is a national priority for eradication in China,” said Li
Yaohua, Chairman of Shandong Yaohua. “The combination of early detection
and immediate results makes the LuViva appealing to the healthcare
professional as well as the patient and her family.”
The Company currently anticipates interim device and disposable sales
for clinical study and demonstration purposes. In Hong Kong, the Company
believes the time to commercial sales is quicker, with device
registration, rather than approval required.
About Shandong Yaohua Medical Instrument Corporation
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 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: 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, 2015
and subsequent filings.
Contacts
Guided Therapeutics
Bill Wells, 770-242-8723
