Guided Therapeutics completes patient enrollment for FDA trial

Guided Therapeutics Inc. (OTCQB: GTHP) announced it has enrolled enough patients to begin closing its U.S. FDA clinical trial for the LuViva Advanced Cervical Scan device and will start data analysis.

The company enrolled approximately 430 patients across four participating clinics, with all sites reaching their minimum specified quotas. The data analysis phase will include completing external review of biopsy samples, reviewing study case report forms, and performing statistical analysis according to the study protocol.

The pathology analysis aims to determine the number of patients with and without disease to ensure a representative mix of disease types. Once this analysis is completed, all clinical sites will stop enrolling additional patients and the clinical report will be filed with the FDA later this year.

The study recorded no adverse events linked to the LuViva device, supporting the FDA's designation of LuViva as a non-significant risk device. The LuViva Advanced Cervical Scan uses biophotonic technology for cervical cancer detection.

"As we move from the testing phase to the analysis phase of the study, we have met the Company's primary 2025 objective," said Mark Faupel, CEO of Guided Therapeutics.

The LuViva Advanced Cervical Scan remains an investigational device limited to investigational use in the U.S. under federal law.

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