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Guided Therapeutics develops the LuViva Advanced Cervical Scan, a non-invasive cervical disease detection platform based on patented biophotonic technology. Company news centers on LuViva clinical-study updates, FDA application activity, and the device’s U.S. investigational status, along with financial-report developments and capital actions tied to common stock and warrants.
Recurring commercial updates include purchase orders, payments, shipments, and supply arrangements with Chinese medical-device distribution partners, including Hangzhou Dongye Medical Technology Company and Yuanshuo Medical Instruments Corporation. These announcements describe LuViva devices and single-use components, distributor relationships, and revenue recognition tied to received payments and product shipments.
Guided Therapeutics (OTCQB: GTHP) has announced that its clinical trial for the LuViva Advanced Cervical Scan is back on track after delays due to Covid-19 lockdowns. The study is expected to be completed and submitted to the Chinese National Medical Products Administration (NMPA) in the first half of 2023. Current results indicate LuViva has met success criteria and is safe for nearly 200 women tested in China. The upcoming results will trigger a $2.5 million purchase order for LuViva devices and disposables from Shandong Yaohua Medical Instrument Corporation.
Guided Therapeutics (OTCQB: GTHP) raised approximately $3.3 million by selling 6.6 million shares at 50 cents each. Each share purchase includes two warrants for future purchases at 50 cents and 65 cents. The funds will primarily be used for clinical study costs related to FDA approval of the LuViva Advanced Cervical Scan and to support international distribution. The company plans to maintain its Nasdaq uplisting application open, focusing on favorable market conditions. Existing investors participated in the funding under reasonable terms.
Guided Therapeutics, Inc. (OTCQB: GTHP) has received Institutional Review Board (IRB) approval to launch a clinical trial for its LuViva Advanced Cervical Scan aimed at obtaining FDA approval. The trial is set to enroll up to approximately 400 women across key medical institutions, starting in 30 to 60 days. LuViva is already CE Mark-approved in the European Union and is undergoing trials in China. CEO Gene Cartwright noted that COVID-19 delays have impacted the trial's initiation.
Guided Therapeutics (OTCQB: GTHP) has completed patient testing for its LuViva Advanced Cervical Scan in a clinical trial seeking NMPA approval in China. The trial, conducted at four sites, involved 150 patients and is expected to conclude in Q2 2023 for subsequent submission. The company received a milestone payment of $177,740 from its partner SMI, which will help supply LuViva devices. Preliminary results indicate good safety and accuracy, supporting the trial's continuation and the upcoming submission.
Guided Therapeutics (GTHP) has commenced patient enrollment and testing for its LuViva Advanced Cervical Scan at the Department of Obstetrics & Gynecology Hospital of Fudan University in Shanghai. This pivotal clinical trial is integral to the company's international commercialization strategy. Upon submission of data to the Chinese NMPA, GTHP is set to receive $620,000 from its partner, Shandong Yaohua Medical Instrument Corporation, with an additional $1.88 million due post-marketing approval. Cervical cancer remains a critical health issue in China, with the LuViva device providing timely screening benefits.
Guided Therapeutics, Inc. (GTHP) announced that its Chinese partner, Shandong Yaohua Medical Instrument Corporation, received ethics board approval for clinical trials using LuViva devices at three hospitals. The study, involving about 400 patients, is set to begin next month. SMI ordered additional LuViva devices, with $100,000 paid towards a total purchase order of $530,000. Another order for $2.5 million is contingent on the filing of clinical study results and subsequent FDA approval in China, with minimum orders of $72 million anticipated post-approval.
Guided Therapeutics (OTCQB: GTHP) announced successful regulatory compliance for its LuViva® Advanced Cervical Scan at Fudan University in Shanghai, paving the way for clinical trials this quarter. The company secured $133,000 from partner Shandong Yaohua Medical Instrument Corporation, aimed at supporting clinical studies in China. Anticipating $3 million in payments by year-end, contingent on Chinese FDA approval, GTHP could receive $510,000 during the trials. Cervical cancer remains a critical health issue in China, indicating a substantial market opportunity for LuViva's point-of-care technology.
Guided Therapeutics, Inc. (OTCQB: GTHP) announced impressive results from an independent study of its LuViva Advanced Cervical Scan. The study with 166 women in Hungary showed LuViva detected 20% more cervical precancer and cancer than the HPV test, boasting a sensitivity of 94%. LuViva also provides immediate results without the need for extensive lab infrastructure. The device has received CE Mark and is set for launch in Central and Eastern Europe this year. The Hungarian medical community sees LuViva as a significant improvement in cervical screening quality.
Guided Therapeutics (OTCQB: GTHP) has announced that its LuViva™ Advanced Cervical Scan has passed safety and electromagnetic compliance tests required for clinical trials in China. The clinical trials, set to begin this quarter, are critical for obtaining Chinese FDA approval and initiating sales, which SMI anticipates in the second half of 2022. With cervical cancer being a significant health issue in China, affecting approximately 560 million women, this milestone represents a crucial step forward for the company's expansion in the Chinese market.
Guided Therapeutics (OTCQB: GTHP) announced the raising of US $1.13 million through a 3-year convertible debenture, aimed at repaying a dilutive convertible note due at 2021's end. The new debenture has a fixed conversion price of $0.50, reducing shareholder dilution compared to the retired note. Additionally, it will convert automatically into securities during a future financing related to a potential Nasdaq uplisting. CEO Gene Cartwright highlighted significant progress in reducing liabilities and enhancing prospects for a Nasdaq listing and regulatory approvals in the US and China.