Guided Therapeutics reports completion of study for Chinese regulatory approval

Guided Therapeutics announced the completion of the clinical trial for marketing and sales approval of the Company’s LuViva Advanced Cervical Scan by the Chinese National Medical Products Administration. The study, which included approximately 450 women, was conducted at four prestigious medical institutions, including Shandong University, Fudan University and Peking University. The study was led by Professor Dr. Kong Beihua of Qilu Hospital at Shandong University and Dr. Sui Long, Director of the Gynecology Hospital at Fudan University. Professor Kong is Vice Chairman of the Chinese Society of Obstetrics and Gynecology Society. The company’s Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation intends to analyze the study results with the participating doctors and file them with the NMPA within the next 90 days. The filing triggers purchase order payments to Guided Therapeutics of approximately $2.2M, with additional significant orders for devices and disposables in 2024 and beyond. “We are extremely pleased that the study has reached its completion, and that its results will be filed soon with NMPA,” said Mark Faupel, CEO of Guided Therapeutics. “We look forward to starting commercialization of LuViva in China in the near future.”