On November 17, 2021 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, reported that enrollment and testing of patients has begun at the Department of Obstetrics & Gynecology Hospital of Fudan University located in Shanghai (Press release, Guided Therapeutics, NOV 17, 2021, View Source [SID1234595749]).
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The data will be submitted to the Chinese National Medical Products Administration (NMPA; formerly known as the Chinese FDA). Upon such submission, $620,000 is due to Guided Therapeutics from the Company’s Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI). The balance of the $2.5 million purchase order from SMI (i.e., $1,880,000) will be due and payable upon marketing approval from NMPA.
"Starting the pivotal clinical trial in China is a key milestone in our international commercialization strategy," said Gene Cartwright, CEO of Guided Therapeutics. "The study is very reasonable in terms of number of women to be tested and it is a pleasure to be working with thought leaders in the Chinese Gynecological and Obstetrics community."
According to the World Health Organization, cervical cancer is 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. It is believed mortality due to cervical cancer has been increasing in China. In response, China has increased efforts to screen more women, especially in rural areas where the laboratory infrastructure for traditional screening tests is lagging. Because LuViva does not require a laboratory infrastructure and produces an immediate result at the point of care, it is well suited to screening women for cervical cancer in these environments.