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 (OTCQB: GTHP) reported preliminary findings from its FDA pivotal clinical trial of the LuViva Advanced Cervical Scan, a biophotonic platform for cervical precancer/cancer detection. Preliminary site pathology analyses show 24 of 97 disease cases (25%) were missed by current standard of care. The company said the study's primary goal is met if LuViva increases detection by at least 12% (≥11 additional detected cases, assuming ~100 diseased subjects). The completed study enrolled ~480 subjects with >420 evaluable for efficacy; all sites are closed and monitoring is complete. Final results are expected to be filed with FDA in about 30–60 days.
Guided Therapeutics (OTC:QB) said it received an $88,000 payment from Hangzhou Dongye Medical Technology (HDMT) on Dec 11, 2025. $80,000 of the payment is the third installment of a $700,000 purchase order received earlier in 2025; the remaining $8,000 is a new order for LuViva components.
The company will ship four LuViva devices and components this month, bringing total devices shipped to seven of 35 due over the next several months. HDMT is the exclusive gynecology products provider for 42 hospitals in Hangzhou, which perform about two million cervical cancer screenings annually. The purchase order was complemented by a new $200,000 initial purchase agreement with Yuanshuo Medical Instruments Corporation (YMIC) in Jiangsu province.
Guided Therapeutics (OTCQB: GTHP) completed an initial supply agreement with Yuanshuo Medical Instruments Corporation (YMIC) on November 19, 2025, under which YMIC will initially purchase $200,000 of LuViva devices and single-use components.
YMIC is headquartered in Jiangsu province and is licensed to sell Class II and Class III medical devices in China. Additional orders are expected next year under a broader supply agreement currently under discussion. This agreement supplements an existing GTHP arrangement to provide 35 devices to Hangzhou Dongye Medical Technology Company, which serves 42 hospitals conducting about 2 million cervical cancer screenings annually.
Guided Therapeutics (OTC:QB GTHP), manufacturer of the LuViva Advanced Cervical Scan, has received a $70,000 payment from Hangzhou Dongye Medical Technology Company (HDMT), its Chinese distribution partner. This marks the second of nine scheduled payments totaling $700,000 for LuViva components and services.
The payment triggers the shipment of three component sets and manufacturing of four additional sets. Upon completion, HDMT will make the next payment of $80,000. HDMT serves as the exclusive gynecology products provider for 42 hospitals in Hangzhou City, conducting approximately 2 million annual cervical cancer screenings.
Guided Therapeutics (OTC:QB GTHP) has completed patient enrollment in its FDA clinical trial for the LuViva Advanced Cervical Scan, a non-invasive cervical cancer detection device. The study successfully enrolled approximately 430 patients across four clinical sites, meeting minimum quota requirements.
The company is now transitioning to data analysis, which includes external review of biopsy samples, case report form evaluation, and statistical analysis. No adverse events were reported during the trial, supporting LuViva's FDA designation as a non-significant risk device. The clinical report is expected to be filed with the FDA later in 2025.
Guided Therapeutics (OTC:QB GTHP), manufacturer of the LuViva Advanced Cervical Scan, has initiated its first shipment to Hangzhou Dongye Medical Technology Company (HDMT) on June 27, 2025. This shipment will generate $117,462 in sales revenue for Q2 2025.
The company has also manufactured and tested three devices from a separate $700,000 purchase order with HDMT, triggering a $70,000 payment expected in July 2025. HDMT serves as the exclusive gynecology products provider for 42 hospitals in Hangzhou City, conducting approximately two million cervical cancer screenings annually.
Guided Therapeutics (OTCQB: GTHP) has received a $100,000 payment from Shandong Yaohua Medical Instrument Corporation's (SMI) investment partners to support the commercialization of its LuViva Advanced Cervical Scan in China. This payment is part of a series of planned payments that extend GTHP's agreement with SMI for LuViva's commercialization, contingent upon receiving Chinese regulatory approval by September 2025. A portion of the funds will be allocated to supply electronic components for LuViva accessories to SMI and its Chinese distribution partners.
Guided Therapeutics (OTCQB: GTHP) has received full payment for an order from Indonesia consisting of four LuViva Advanced Cervical Scan devices and 1,200 single-use cervical guides. The equipment will be delivered in Q1 2025 to the government healthcare system in Sulawesi, an island with over 20 million inhabitants.
The LuViva systems will be used for early detection of cervical cancer, which is one of the most common female cancers in Indonesia. The technology is particularly suitable for the Indonesian healthcare system as it provides immediate results without requiring laboratory infrastructure. The company expects additional orders in the following year.
Guided Therapeutics (OTCQB: GTHP) announced that its Chinese partner, Shandong Yaohua Medical Instrument (SMI), has filed an application for LuViva Advanced Cervical Scan with the Chinese National Medical Products Administration (NMPA). The application included results from a study of 449 women at four leading medical institutions in China, showing a test sensitivity of 83% and specificity of 54%, exceeding the required success criteria.
The study results support LuViva's potential use in diagnosing and screening for cervical disease in its early, treatable stages. LuViva could help 54% of women avoid unnecessary biopsies with 93% confidence in negative results. As a screening test, LuViva's 83% ability to identify moderate and high-grade precancer outperforms the average 40%-50% of Pap tests.
The NMPA filing continues the partnership between Guided Therapeutics and SMI, with potential milestones and payments exceeding $125 million over six years for devices, disposables, services, and royalties.
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