How are energy investors positioned?
PEACHTREE CORNERS, Ga. - Guided Therapeutics, Inc. (OTCQB:GTHP), a $12 million market cap medical device company that has seen its stock surge over 71% in the past year, announced Wednesday it has completed patient enrollment for its clinical study of the LuViva Advanced Cervical Scan, reaching approximately 430 patients across four participating clinics.
The company will now begin analyzing data from the study, which includes completing external review of biopsy samples, processing case report forms, and performing statistical analysis according to the study protocol. Once this analysis is completed, all clinical sites will stop enrolling additional patients. According to InvestingPro data, the company currently operates with limited liquidity, as short-term obligations exceed liquid assets.
Guided Therapeutics expects to file the clinical report with the FDA later this year. The company also reported no adverse events linked to the LuViva device during the study, supporting the FDA’s designation of LuViva as a non-significant risk device.
"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, in a press release statement.
The LuViva Advanced Cervical Scan is designed to detect cervical disease using biophotonic technology that utilizes light for early detection at the cellular level. The device remains investigational and is limited by federal law to investigational use in the United States.
Guided Therapeutics describes the technology as non-invasive and capable of providing instant results at the point of care. The company is pursuing regulatory approval to bring the device to market.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.