Welcome to our dedicated page for Guided Thera news (Ticker: GTHP), a resource for investors and traders seeking the latest updates and insights on Guided Thera stock.
Guided Therapeutics, Inc. (OTCQB: GTHP) is a medical device company in the surgical and medical instrument manufacturing industry that focuses on early disease detection using patented biophotonic technology. Its news flow centers on the development, clinical evaluation and commercialization of the LuViva® Advanced Cervical Scan, a non-invasive device designed to detect cervical disease instantly at the point of care.
News updates for Guided Therapeutics frequently cover clinical milestones, such as progress and preliminary findings from its U.S. FDA pivotal clinical trial and study results used to support an application to the Chinese National Medical Products Administration. These reports describe how LuViva is being evaluated for its ability to detect cervical precancers and cancers that may be missed by current screening and diagnostic practices.
Investors and observers can also find announcements about distribution and commercialization agreements in multiple regions. Recent press releases describe purchase orders, payments and shipments of LuViva devices and single-use components to partners in China, including Shandong Yaohua Medical Instrument Corporation, Hangzhou Dongye Medical Technology Company Ltd and Yuanshuo Medical Instruments Corporation, as well as an order for devices and disposables for the government healthcare system in Sulawesi, Indonesia.
On this news page, readers can follow company statements on regulatory submissions, clinical trial enrollment and analysis, and commercial arrangements related to LuViva. These updates provide insight into how Guided Therapeutics is advancing its cervical disease detection technology through studies, regulatory processes and partnerships. For those tracking GTHP, the news stream offers context on the company’s progress in moving from investigational use and clinical evaluation toward broader deployment of its diagnostic platform, subject to regulatory review and market adoption.
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.
Guided Therapeutics, Inc. (OTCQB: GTHP) has successfully closed its Series F Preferred Stock Financing, raising $2.114 million in gross proceeds. The funds will primarily complete the FDA clinical trial for the LuViva® Advanced Cervical Scan, expected to begin in Q2 2021. The Series F shares, convertible at 25 cents, carry a 6% annual dividend, with potential additional dividends if certain conditions are unmet. CEO Gene Cartwright emphasized the importance of this funding for completing the FDA study and reducing company liabilities, setting the stage for a potential uplisting.
Guided Therapeutics, Inc. (OTCQB: GTHP) announced raising US $1.1 million in its Series F Preferred Stock Offering, targeting a minimum of $1 million. The funds will finalize a $750,000 payment to GPB Holdings and support an FDA clinical trial for the LuViva Advanced Cervical Scan. The completion of this study is crucial for the company. The Series F shares are convertible at 25 cents each and carry a 6% dividend, potentially increasing to 15% if certain conditions are unmet. CEO Gene Cartwright expressed confidence in the funding aiding company growth and advancing clinical trials.
Guided Therapeutics, Inc. (OTCQB: GTHP) has completed a final $750,000 payment to GPB Capital Holdings, LLC, concluding a cash and equity exchange agreement from January 16, 2020. This payment has eradicated $5,070,000 in liabilities from the Company's balance sheet, including the removal of GPB's security interests in its assets and setting warrants at a fixed price. CEO Gene Cartwright expressed satisfaction with this achievement, stating it will allow the company to focus on growth without substantial debt payments.
Guided Therapeutics (OTCQB: GTHP) announced a new purchase order worth $530,695 from its Chinese partner, Shandong Yaohua Medical Instrument Corporation (SMI). This order follows a larger existing order of $2.5 million. The new order indicates progress towards FDA approval of LuViva, expected in early 2022. Guided Therapeutics anticipates revenues from China to exceed $1 million in 2021. Cervical cancer remains a significant health issue in China, highlighting the potential market for their advanced detection technology.
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