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 completed software changes and documentation required by the Chinese FDA for marketing approval in China. The Company has worked together with its Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation, to prepare for filing with the Chinese FDA. Shandong has previously issued a purchase order to the Company in the amount of $2,538,070, one quarter of which is to be paid to Guided Therapeutics upon filing with the Chinese FDA and the remainder to be paid once Chinese FDA approval is granted.
"The process of completing the necessary software changes and documentation has been more arduous than expected and was impacted by the current Covid-19 pandemic, first in China and then here in the United States, so we are pleased to get this important step behind us," said Gene Cartwright, CEO of Guided Therapeutics. "Now that it has been completed and the epidemic has abated in China, Shandong can move forward with testing of the device and then filing with the Chinese FDA.
"We are pleased Guided Therapeutics and Shandong have completed this phase of the approval process and look forward to completing the application file for gaining approval from the Chinese FDA," said Yaohua Li, Chairman of Shandong. "We continue to have confidence that the Chinese market will be especially strong for this groundbreaking technology. We expect to file with the Chinese FDA this year and would plan to receive approval next year."
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, 2019 and subsequent filings.
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