NORCROSS, Ga.--(BUSINESS WIRE)--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 (CFDA) approval.
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.