Guided Therapeutics Announces Completion of Clinical Study for Chinese Regulatory Approval
Guided Therapeutics, Inc. (OTCQB: GTHP) announced the completion of a clinical trial for marketing and sales approval of the LuViva Advanced Cervical Scan by the Chinese National Medical Products Administration (NMPA). The study, involving about 450 women, was conducted at prestigious medical institutions, including Shandong University, Fudan University, and Peking University. The study was led by prominent doctors, and the results will be filed with NMPA within the next 90 days, triggering purchase order payments to Guided Therapeutics of approximately $2.2 million, with more significant orders expected in 2024 and beyond.
Positive
Completion of the clinical trial is a positive milestone for Guided Therapeutics, positioning the company for commercialization of LuViva in China. The involvement of prestigious medical institutions and prominent doctors adds credibility to the study results and the product's potential in the Chinese market.
11/20/2023 - 09:51 AM
PEACHTREE CORNERS, Ga.--(BUSINESS WIRE)--
Guided Therapeutics, Inc. (OTCQB: GTHP) announced today the completion of the clinical trial for marketing and sales approval of the Company’s LuViva Advanced Cervical Scan by the Chinese National Medical Products Administration (NMPA). The study, which included approximately 450 women, was conducted at four prestigious medical institutions, including Shandong University, Fudan University and Peking University. The study was led by Professor Dr. Kong Beihua of Qilu Hospital at Shandong University and Dr. Sui Long, Director of the Gynecology Hospital at Fudan University. Professor Kong is Vice Chairman of the Chinese Society of Obstetrics and Gynecology Society.
The Company’s Chinese co-manufacturing partner and distributor for China , Shandong Yaohua Medical Instrument Corporation (SMI) intends to analyze the study results with the participating doctors and file them with the NMPA within the next 90 days. The filing triggers purchase order payments to Guided Therapeutics of approximately $2.2 Million
“We are extremely pleased that the study has reached its completion, and that its results will be filed soon with NMPA,” said Mark Faupel, CEO of Guided Therapeutics. “We look forward to starting commercialization of LuViva in China in the near future.”
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, 2022 and subsequent filings.
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Mark Faupel
Source: Guided Therapeutics, Inc.
What is the LuViva Advanced Cervical Scan?
The LuViva Advanced Cervical Scan is a medical device developed by Guided Therapeutics, Inc. for early detection of cervical cancer.
What is the significance of the completion of this clinical trial?
The completion of the clinical trial is a crucial step towards obtaining marketing and sales approval for the LuViva Advanced Cervical Scan in China.
Who conducted the study for the LuViva Advanced Cervical Scan?
The study was conducted at prestigious medical institutions, including Shandong University, Fudan University, and Peking University, led by prominent doctors such as Professor Dr. Kong Beihua and Dr. Sui Long.
What are the expected financial implications of the study results?
The filing of the study results with the NMPA is expected to trigger purchase order payments to Guided Therapeutics of approximately $2.2 million, with additional significant orders for devices and disposables anticipated in 2024 and beyond.
