Leading Cervical Cancer Doctors Support Approval of LuViva in China Based on Preliminary Review of Clinical Trial Results

Rhea-AI Summary

Guided Therapeutics, Inc. (GTHP) announces final stages of clinical data report for LuViva Advanced Cervical Scan approval in China. Expected approval by Chinese NMPA with positive feedback from prominent doctors. Commercialization payments from Chinese partner to exceed $4 million in 2024.

PEACHTREE CORNERS, Ga.--(BUSINESS WIRE)-- Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, announced today that a group of prominent cervical cancer doctors are in the final stages of completing the clinical data report that will be submitted for approval by the Chinese National Medical Products Administration (NMPA). The data quality assurance review team is being led by Dr. Sui Long, Director of the Gynecology Hospital at Fudan University and includes physicians from Qilu Hospital at Shandong University and two hospitals in Shanghai. The quality assured data report is expected by the end of this month with final statistics from the study to be available early in March. According to Dr. Sui, “We are eager to complete the validation of this innovative technology and submit an application to the NMPA, and we are confident that LuViva will represent the next generation of early cervical cancer detection technology, with its advantages of accuracy, ease of use and immediate results.”

Based on the progress described above, the Company’s Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI) will start making significant commercialization payments to Guided Therapeutics. Beginning with a payment to GTHP of $500,000 in March, total payments for 2024 are expected to be more than $4 million and will consist of royalty payments, as well as payments for devices and associated disposables. SMI’s CEO, Mr. Yaohua Li reported that “We already have pre-orders from multiple provinces in China for nearly 100 devices and thousands of disposables. This makes us very optimistic about the future of LuViva sales in China.”

“We are delighted to gain the support of China’s elite Gyn physicians for Luvia, and look forward to the imminent filing of the clinical data with the Chinese NMPA,” said Mark Faupel, President and CEO of Guided Therapeutics.

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

Guided Therapeutics

770-242-8723

Source: Guided Therapeutics, Inc.

FAQ

When will the clinical data report for LuViva Advanced Cervical Scan be submitted for approval by the Chinese NMPA?

The clinical data report is expected to be submitted for approval by the Chinese NMPA by the end of this month.

Who is leading the data quality assurance review team for the clinical data report?

Dr. Sui Long, Director of the Gynecology Hospital at Fudan University, is leading the data quality assurance review team for the clinical data report.

What are the expected commercialization payments from the Chinese co-manufacturing partner and distributor, Shandong Yaohua Medical Instrument Corporation, to Guided Therapeutics in 2024?

Total payments for 2024 are expected to be more than $4 million, including royalty payments, payments for devices, and associated disposables.

How many pre-orders does Shandong Yaohua Medical Instrument Corporation have for LuViva devices in China?

Shandong Yaohua Medical Instrument Corporation has pre-orders from multiple provinces in China for nearly 100 devices and thousands of disposables.