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Guided Therapeutics completes clinical study for Chinese Regulatory approval of LuViva Advanced Cervical Scan
20 November 2023 -

Guided Therapeutics Inc (OTCQB: GTHP), a specialist in a rapid and painless testing platform based on patented biophotonic technology for the early detection of diseases at the cellular level, declared on Monday that it has concluded a clinical trial involving approximately 450 women, conducted at prestigious medical institutions including Shandong University, Fudan University and Peking University, for the marketing and sales approval of its LuViva Advanced Cervical Scan by the Chinese National Medical Products Administration (NMPA).

The LuViva Advanced Cervical Scan is the company's first product and is a non-invasive device designed for instant cervical disease detection at the point of care. In clinical trials, the technology demonstrated the ability to detect cervical cancer up to two years earlier than conventional modalities. Guided Therapeutics anticipates further orders for devices and disposables, positioning the LuViva Advanced Cervical Scan as a valuable tool in disease detection.

Professor Dr. Kong Beihua and Dr Sui Long led the study. Guided Therapeutics' co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI), plans to analyze the results and submit them to the NMPA within the next 90 days.

Upon filing, Guided Therapeutics expects purchase order payments of approximately USD2.2m, with additional significant orders projected for 2024 and beyond.