Guided Therapeutics, Inc. Announces Start of Chinese Clinical Trial for Approval to Market and Sell LuViva in China
November 17, 2021 at 07:35 pm IST
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Guided Therapeutics, Inc. announced that enrollment and testing of patients has begun at the Department of Obstetrics & Gynecology Hospital of Fudan University located in Shanghai. 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. 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.
Guided Therapeutics, Inc. is a medical technology company. The Company is focused on developing medical devices that have the potential to improve healthcare. The Companyâs primary focus is the sales and marketing of its LuViva Advanced Cervical Scan non-invasive cervical cancer detection device. The underlying technology of LuViva primarily relates to the use of biophotonics for the non-invasive detection of cancers. LuViva is designed to identify cervical cancers and precancers painlessly, non-invasively and at the point of care by scanning the cervix with light, then analyzing the reflected and fluorescent light. LuViva is designed to provide a less invasive and painless alternative to conventional tests for cervical cancer screening and detection. Additionally, LuViva is designed to improve patient well-being not only because it eliminates pain, but also because it is convenient to use and provides rapid results at the point of care.