Guided Therapeutics, Inc. news
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, announced today that testing of 150 patients has been completed in the ongoing clinical trial for Chinese National Medical Products Administration (NMPA) approval. 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.
In addition, the Company’s Chinese co-manufacturing partner and
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, announced today 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 fr
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, announced today that its Chinese partner, Shandong Yaohua Medical Instrument Corporation (SMI), had received ethics board approval and placed LuViva devices at two of the three participating hospitals for clinical trials aimed at achieving Chinese FDA approval. The clinical study is expected to start next month, include approximately 400 patients and be comple
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva® Advanced Cervical Scan, based on its patented biophotonic technology, announced today 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
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, announced today that an independent study of 166 women in Hungary showed that LuViva detected 20% more cervical precancer and cancer than the HPV test. Specifically, LuViva had a very high sensitivity of 94%, detecting disease in 48 of 51 women with biopsy results of precancer or cancer, compared with 40 detected by HPV for the same group of 51 women. In addit