On July 20, 2021 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, reported its Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI), has received notice from the Jinan Medical Device Quality Supervision and Testing Center of the State Food and Drug Administration that LuViva has passed safety and electromagnetic compliance requirements necessary to be used in clinical trials (Press release, Guided Therapeutics, JUL 20, 2021, View Source [SID1234584994]). The clinical trials are expected to begin this quarter and SMI estimates that Chinese FDA approval and initial sales in China will occur in the second half of 2022. SMI reports that it has signed sub-distributor contracts for three provinces in expectation of Chinese FDA approval next year.
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"Passing compliance testing certified by the Chinese State Food and Drug Administration is a major milestone for us," said Gene Cartwright, CEO of Guided Therapeutics. "We expect progress in China to accelerate based on this milestone, which allows the start of the clinical study in China."
According to the World Health Organization, cervical cancer is ranked as one of the most frequent cancers in women in the world, and in China it is the second most common cancer among women. China has a population of approximately 560 million women above 15 years of age, who are at risk of developing cervical cancer. Current estimates indicate approximately 100,000 new cases of cervical cancer are diagnosed each year, and 30,000 deaths occur annually due to cervical cancer in China.