Guided Therapeutics says preliminary analysis of FDA study data completed

Guided Therapeutics (GTHP) provided several updates in conjunction with the Company’s 2025 10k financial report, filed on March 30. 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. “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 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 20M 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 at a reduced price if the exercised prior to February 20. For holders who chose to participate in the offering, certain of their remaining warrants had their expiration dates extended an additional year.