On August 19, 2021 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, reported it had passed the regulatory compliance review at the Department of Obstetrics & Gynecology Hospital of Fudan University located in Shanghai (Press release, Guided Therapeutics, AUG 19, 2021, View Source [SID1234586765]). Clinical trials there and at three other centers are expected to begin this quarter.
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GTHP also received a payment of $133,000 from its Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI). The funds will be used to supply SMI with parts and advice for the Chinese clinical study. Parts are expected to ship this quarter and additional participating clinical sites announced over the next few weeks. SMI estimates that the clinical study will be completed during the second quarter of 2022 with full approval to sell in China expected by the end of 2022.
Under a new agreement with SMI signed last week, GTHP expects payments totaling approximately $3 Million by the end of 2022, assuming Chinese FDA approval is granted. Approximately $510,000 of those payments is expected to be received by GTHP during the clinical study, with the majority of those funds to be received this year. The remaining $2.5 million, based on a purchase order from SMI, is due upon filing the clinical study results with Chinese FDA ($620,000) and approval by Chinese FDA ($1,880,000). The new contract then calls for minimum orders of $72 Million over the first four years post Chinese FDA approval.
"We continue to be encouraged by the regulatory approvals from China," said Gene Cartwright, CEO of Guided Therapeutics. "Fudan University is recognized as a top tier research institution and viewed by Chinese FDA as a highly credible center at which to conduct our clinical study."
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.