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 purchase order in the amount of $2,538,070 from its Chinese co-manufacturing partner and distributor for China, Shandong Yaohuo Medical Device Technology Company, Ltd. Shandong has previously paid Guided Therapeutics nearly $1 million in license payments and invested upwards to another $1 million in infrastructure in China for the roll out of LuViva either later this year or early next year. The purchase order includes parts for final assembly of LuViva along with single use disposables that are consumed with each LuViva test. Approximately 25% of the purchase order will be paid upon Shandong’s filing with the Chinese FDA with the remainder due once Chinese FDA approval is obtained, which is expected within about one year. Shandong has estimated that it will assemble and distribute 200 LuViva devices in China over the next 12 to 18 months. The Chinese FDA has determined that LuViva is a Class 2 medical device, a designation that allows Shandong to apply through its provisional Chinese FDA office as opposed to Class 3 Devices that must apply through the national office in Beijing. As such, the Class 2 designation is expected to result in a faster approval than a Class 3 designation.
“We are gratified that the plan to launch LuViva in China with Shandong is progressing according to schedule,” said Gene Cartwright, CEO of Guided Therapeutics. “The purchase order we received, along with the potential size of the Chinese market for us, provides potential for a record year in LuViva revenues.”
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.