Analysis of Guided Therapeutics' FDA Study Data Reveals Compelling Clinical Need for LuViva

PEACHTREE CORNERS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. (OTCQB: 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 preliminary findings from its FDA pivotal clinical trial demonstrate that there is a strong clinical need for LuViva's ability to detect cases of cervical precancer and cancer currently missed by the standard of care. Specifically, the study’s preliminary results show that current practice fails to detect a substantial percentage of early cervical precancers for women referred to biopsy based on abnormal Pap and/or HPV results.

According to Mark Faupel, CEO of Guided Therapeutics, “Previous studies have shown that the current practice consisting of biopsies based on colposcopy (a magnified view of the cervix after application of acetic acid) can miss significant disease 20 to 40 percent of the time. In our study, the primary goal is to show that LuViva can detect these hard-to-find precancers and cancers.” Added Mr. Faupel, “Our expectation is that the study results will show that LuViva can increase the rate of detection by at least 12%. Stated another way, the primary goal of the study will be met if LuViva detects at least 11 cases with disease missed by the current standard of care, assuming approximately 100 women in the study have disease.”

Thus far, preliminary analyses based on each patient’s clinical site pathology findings show that 24 of 97 cases of disease (25%) were missed by the current standard of care. Previous studies have shown that LuViva detects the majority of early precancers and cancers, which augers well for meeting the study’s primary goal. To reach a final diagnosis for each patient, pathology results also include diagnoses made by independent expert pathologists.

The completed study includes approximately 480 enrolled subjects, of whom over 420 will be evaluated for efficacy. Both these numbers meet criteria set forth in the study protocol reviewed by FDA prior to the start of the study. All study sites are closed and monitoring completed. Final clinical results are expected to be filed with FDA within about 30 to 60 days.

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.