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Guided Therapeutics (OTCQB: GTHP) has announced that its clinical trial for the LuViva Advanced Cervical Scan is back on track after delays due to Covid-19 lockdowns. The study is expected to be completed and submitted to the Chinese National Medical Products Administration (NMPA) in the first half of 2023. Current results indicate LuViva has met success criteria and is safe for nearly 200 women tested in China. The upcoming results will trigger a $2.5 million purchase order for LuViva devices and disposables from Shandong Yaohua Medical Instrument Corporation.
Positive
The clinical trial for LuViva is back on track after Covid-related delays.
Initial results show LuViva meets success criteria and is safe for use.
Successful completion of the trial could trigger a $2.5 million purchase order.
Negative
None.
PEACHTREE CORNERS, Ga.--(BUSINESS WIRE)--
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, announced today that the clinical trial for Chinese regulatory is back on track after experiencing delays due to Covid-19 lockdowns and is expected to be completed and filed with the Chinese National Medical Products Administration (NMPA) during the first half of 2023.
According to Guided Therapeutics Chinese partner, Shandong Yaohua Medical Instrument Corporation (SMI), the results so far indicate that LuViva meets or exceeds the success criteria as described in the current study protocol and has been demonstrated to be safe for use on nearly 200 women tested thus far in China. Hospitals participating in the study include Qilu Hospital of Shandong University, Fudan (Shanghai) University Hospital and Peking University People’s Hospital.
“We are very pleased to hear that the study is progressing well, both in terms of patient recruitment and the performance of LuViva,” said Gene Cartwright, CEO of Guided Therapeutics. “Despite sporadic lockdowns due to Covid-19 prevention mandates, study enrollment is now accelerating, and SMI projects that the study results will be filed with the Chinese NMPA sometime in the first half of next year. These events trigger the start of a $2.5 MM purchase order from SMI for LuViva devices and disposables.”
According to the World Health Organization, cervical cancer is one of the most frequent cancers worldwide and is the second most common cancer among Chinese 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. (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, 2021 and subsequent filings.
What is the status of the GTHP clinical trial in China?
The clinical trial for Guided Therapeutics' LuViva Advanced Cervical Scan is back on track and expected to be completed in the first half of 2023.
What are the initial results of the LuViva clinical trial?
Initial results indicate that LuViva meets or exceeds the success criteria and has been demonstrated to be safe for nearly 200 women tested in China.
What financial implications does the trial have for GTHP?
Upon successful completion of the clinical trial, a $2.5 million purchase order for LuViva devices and disposables is expected from Shandong Yaohua Medical Instrument Corporation.
How significant is cervical cancer in China related to GTHP's products?
Cervical cancer is a significant health issue in China, with approximately 100,000 new cases diagnosed annually, creating a strong market potential for LuViva.
