On March 31, 2022 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, reported that testing of 150 patients has been completed in the ongoing clinical trial for Chinese National Medical Products Administration (NMPA) approval (Press release, Guided Therapeutics, MAR 31, 2022, View Source [SID1234611315]). The trial is underway at four sites in China. The trial is expected to be completed in the second quarter of this year and submitted for approval shortly thereafter.
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In addition, the Company’s Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI), made a scheduled milestone payment to the Company of $177,740. A portion of these funds will be used to supply SMI with LuViva devices and parts. According to SMI, both the interim safety and accuracy results of LuViva justify the completion of the clinical study and submission of the data to the NMPA as soon as practicable.
"We are pleased to hear that LuViva has performed well and as expected in the first clinical trials in China," said Gene Cartwright, CEO of Guided Therapeutics. "We look forward to a speedy conclusion and filing of study results with the Chinese regulatory authorities."