PEACHTREE CORNERS, Ga.--(BUSINESS WIRE)--Aug 13, 2025--
Guided Therapeutics, Inc. (OTC:QB GTHP), the maker of the LuViva Advanced Cervical Scan, a rapid and painless testing platform for cervical cancer detection based on its patented biophotonic technology, announced today that it had enrolled enough patients to begin closing out the study and starting data analysis. Data analysis will consist of completing the ongoing external review of all biopsy samples, reviewing and entering data from the study case report forms and performing the statistical analysis pursuant to the study protocol. All four participating clinics have reached their minimum specified quotas resulting in a total of approximately 430 patients enrolled. Part of the pathology analysis is intended to determine the number of patients with and without disease to ensure a representative mix of disease types. Once this part of the analysis has been completed, all clinical sites will be closed out from enrolling additional patients and the clinical report will be filed with the FDA, expected later this year. Additionally, there have been no adverse events linked to the use of the LuViva device, further supporting FDA’s designation of LuViva as a non-significant risk device.
“We want to thank all of physicians and staff at the clinical sites who made this study possible,” said Mark Faupel, CEO of Guided Therapeutics. “As we move from the testing phase to the analysis phase of the study, we have met the Company’s primary 2025 objective. We are optimistic that we have conducted a successful study and look forward to the results of the statistical analyses.”
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, 2024 and subsequent filings.
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CONTACT: Mark Faupel
Guided Therapeutics
770-242-8723
KEYWORD: UNITED STATES NORTH AMERICA GEORGIA
INDUSTRY KEYWORD: MEDICAL DEVICES MEDICAL SUPPLIES FDA CLINICAL TRIALS HEALTH TECHNOLOGY BIOTECHNOLOGY GENERAL HEALTH PHARMACEUTICAL HEALTH ONCOLOGY
SOURCE: Guided Therapeutics, Inc.
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PUB: 08/13/2025 09:00 AM/DISC: 08/13/2025 08:59 AM
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