Guided Therapeutics Receives Notification of Successful Clinical Trial Regulatory Review and $133,000 Payment from China
August 19, 2021 at 09:05 am EDT
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Guided Therapeutics, Inc. announced it had passed the regulatory compliance review at the Department of Obstetrics & Gynecology Hospital of Fudan University located in Shanghai. Clinical trials there and at three other centers are expected to begin this quarter. 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.
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.
GUIDED THERAPEUTICS, INC. 
