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, provided several updates in conjunction with the Company’s 2025 10k financial report, filed on March 30, 2026.
First, preliminary analysis of the FDA clinical study data has been completed. Over 480 women participated in the multicenter trial and there were no adverse events associated with use of LuViva. Of the nearly 100 women determined by independent expert pathology to have significant cervical disease that can lead to cancer, approximately 30% went undetected by the current standard of care consisting of colposcopy followed by biopsy. The primary objective of the study was to show that LuViva could detect a significant number of these “missed” precancers as set forth in the FDA reviewed protocol.
According to Mark Faupel, CEO of Guided Therapeutics, “We are now confident that the FDA required minimum number of 11 cases missed by the standard of care and detected by LuViva has been exceeded by a comfortable margin, thus meeting the study’s primary endpoint. In other words, LuViva detected most of the disease missed by the current standard of care." Completion of the data analysis allows the results to be filed for marketing approval with FDA within the next few weeks.
Second, the Company’s 2025 income showed strong year-over-year growth, reflecting progress in advancing international regulatory and commercial partnerships. The Company secured purchase orders from two new distributors in China ahead of anticipated NMPA approval and advanced discussions with the Turkish Ministry of Health ("MOH") to support nationwide cervical cancer screening. The MOH has indicated that, with broader adoption within Turkey’s national healthcare system, annual usage may reach up to 20 million LuViva tests.
Finally, in February of this year, the Company raised $980,000 via a warrant exchange offering. Holders were offered the right to exercise certain warrants set to expire on September 1, 2026 at a reduced price if the exercised prior to February 20, 2026. For holders who chose to participate in the offering, certain of their remaining warrants had their expiration dates extended an additional year.
Additional details regarding the information contained in this press release can be found in the Company’s 10k financial report, filed on March 30, 2026.
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, 2025, and subsequent filings.
Contacts
Mark Faupel
Guided Therapeutics
770-242-8723
