Articles from Guided Therapeutics, Inc.

Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, announced it had completed an initial supply agreement with Yuanshuo Medical Instruments Corporation (YMIC). YMIC is headquartered in Jiangsu province, China and is licensed by the Chinese government to sell and distribute both Class II and Class III medical devices. According to the agreement, YMIC will initially purchase $200,000 worth of LuViva devices and single-use components. Additional orders are expected next year under a broader supply agreement currently under discussion. The new agreement with YMIC is in addition to the current agreement GTHP has with Hangzhou Dongye Medical Technology Company, Ltd. (HDMT) to provide them with 35 devices. HDMT is in Hangzhou City, Zhejiang Province, where it is the exclusive provider of gynecology products for 42 hospitals that perform approximately two million cervical cancer screenings annually.

Guided Therapeutics, Inc. (OTC:QB GTHP), the maker of the LuViva Advanced Cervical Scan, announced that on August 14th 2025, it had received a payment of $70,000 from its new distribution partner in China, Hangzhou Dongye Medical Technology Company, Ltd. (HDMT). This is the second scheduled payment in a series of nine payments that will total $700,000 in exchange for LuViva components and services. Thus far a total of $100,000 has been received by GTHP. The $70,000 payment received on August 14th 2025 triggers the shipment of three sets of components to HDMT and the manufacture of four additional sets of components. Once these four sets of components are assembled and tested, it will trigger the next payment of $80,000 from HDMT. Revenue from these sales is recognized once payments have been received and products are shipped. HDMT is in Hangzhou City, Zhejiang Province, where it is the exclusive provider of gynecology products for 42 hospitals that perform approximately two million cervical cancer screenings annually.

Guided Therapeutics, Inc. (OTC:QB GTHP), the maker of the LuViva Advanced Cervical Scan, a rapid and painless testing platform for cervical cancer detection based on its patented biophotonic technology, announced today that it had enrolled enough patients to begin closing out the study and starting data analysis. Data analysis will consist of completing the ongoing external review of all biopsy samples, reviewing and entering data from the study case report forms and performing the statistical analysis pursuant to the study protocol. All four participating clinics have reached their minimum specified quotas resulting in a total of approximately 430 patients enrolled. Part of the pathology analysis is intended to determine the number of patients with and without disease to ensure a representative mix of disease types. Once this part of the analysis has been completed, all clinical sites will be closed out from enrolling additional patients and the clinical report will be filed with the FDA, expected later this year. Additionally, there have been no adverse events linked to the use of the LuViva device, further supporting FDA’s designation of LuViva as a non-significant risk device.

Guided Therapeutics, Inc. (OTC:QB GTHP), the maker of the LuViva Advanced Cervical Scan, announced that on June 27th that it made its first shipment of devices and single use components to Hangzhou Dongye Medical Technology Company, Ltd. (HDMT). This order is in addition to future shipments connected with a separate $700,000 purchase order executed earlier this year between HDMT and GTHP. Based on the June 27th shipment, GTHP will recognize an additional $117,462 in sales revenue for the second quarter of 2025. The first three devices from the new $700,000 order have been manufactured and tested, triggering a $70,000 payment from HDMT expected in July 2025. HDMT is in Hangzhou City, Zhejiang Province, where it is the exclusive provider of gynecology products for 42 hospitals that perform approximately two million cervical cancer screenings annually.

Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, announced today that it had received a purchase order and first payment from Hangzhou Dongye Medical Technology Company Ltd (HDMT) for 35 LuViva systems. HDMT will order directly from Guided Therapeutics and the devices will be assembled and tested by Guided Therapeutics’ Chinese partner, Shandong Yaohua Medical Instrument Corporation (SMI). HDMT is in Hangzhou City, Zhejiang Province, where it is the exclusive gynecology products provider for 42 hospitals that perform approximately two million cervical cancer screenings annually.

Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, announced today that it had received a $100,000 payment from Shandong Yaohua Medical Instrument Corporation (SMI) via its investment partners to assist in commercializing LuViva in China. The $100,000 payment is the first of several such payments that provide for an extension of GTHP’s agreement with SMI to commercialize LuViva in China upon regulatory approval in China by September of this year. A portion of the proceeds will be used to supply SMI and its partner distributors in China with electronic components used in certain LuViva accessories.

Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, announced today that it had received full payment from its Indonesian distribution partner for four LuViva devices and 1,200 single-use cervical guides. Delivery of the systems is expected to occur in the first quarter of 2025. This initial shipment of LuViva devices for the government healthcare system in Sulawesi will be utilized to identify women with cervical cancer at its earliest stages, when it is most treatable.

Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, announced today that its Chinese Partner, Shandong Yaohua Medical Instrument Corporation (SMI), has filed its application for LuViva with the Chinese National Medical Products Administration (NMPA). The application included results from 449 women tested at four leading medical institutions in China. The results of the study were above that required for a successful study as defined by the study protocol, with a test sensitivity of 83% and a test specificity of 54%.

Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, announced today that leading physicians from four prestigious medical centers have completed their review and signed off on the study results for submission to the Chinese National Medical Products Administration (NMPA). Approximately 460 women were tested with LuViva at four leading hospitals in China. There were no adverse events reported with the use of LuViva during the study, proving once again that LuViva is safe when used as directed. The study was led by Professor Dr. Kong Beihua of Qilu Hospital at Shandong University and Dr. Sui Long, Director of the Gynecology Hospital at Fudan University. Professor Kong is the current Vice Chairman of the Chinese Society of Obstetrics and Gynecology Society. Dr. Sui has summarized the results of the four clinics and his report, along with other information required by NMPA, is expected to be filed within the next four to five weeks. While the actual results in terms of test accuracy will be known when filed with NMPA, the physicians who reviewed and compiled the data believe the results are “well above that expected by NMPA” and therefore “are expected to result in approval of LuViva for sale in China.”

Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, announced today that a group of prominent cervical cancer doctors are in the final stages of completing the clinical data report that will be submitted for approval by the Chinese National Medical Products Administration (NMPA). The data quality assurance review team is being led by Dr. Sui Long, Director of the Gynecology Hospital at Fudan University and includes physicians from Qilu Hospital at Shandong University and two hospitals in Shanghai. The quality assured data report is expected by the end of this month with final statistics from the study to be available early in March. According to Dr. Sui, “We are eager to complete the validation of this innovative technology and submit an application to the NMPA, and we are confident that LuViva will represent the next generation of early cervical cancer detection technology, with its advantages of accuracy, ease of use and immediate results.”

Guided Therapeutics, Inc. (OTCQB: GTHP) announced today the completion of the clinical trial for marketing and sales approval of the Company’s LuViva Advanced Cervical Scan by the Chinese National Medical Products Administration (NMPA). The study, which included approximately 450 women, was conducted at four prestigious medical institutions, including Shandong University, Fudan University and Peking University. The study was led by Professor Dr. Kong Beihua of Qilu Hospital at Shandong University and Dr. Sui Long, Director of the Gynecology Hospital at Fudan University. Professor Kong is Vice Chairman of the Chinese Society of Obstetrics and Gynecology Society.

Guided Therapeutics, Inc. or the “Company” (OTCQB: GTHP), the maker of LuViva, a rapid and painless cervical cancer detection system based on the Company’s patented biophotonic technology, provided an update regarding the start of its pivotal clinical trial. The results of this clinical study will be used to support the Company’s application for U.S. FDA approval. The clinics involved in the study represent a mix of academic and community practices as well as representative population demographics. The first of the two academic centers opened for study recruitment in April and expects enrollment and testing to commence on their next colposcopy clinic scheduled for May 5th. At the second academic center, all internal scientific and institutional review boards have approved the study and final preparations are being made to begin training there. The two community-based clinics have approved the study, signed clinical trial agreements, and are preparing to start the study. It is estimated that approximately 400 women will be tested. Additional information regarding the study can be found at Clinicaltrials.gov.

Guided Therapeutics, Inc. (the “Company”) (OTCQB: GTHP), the maker of the LuViva® Advanced Cervical Scan, announced today that it had signed a new agreement (the “Agreement”) with the Company’s Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (“SMI”). This Agreement supersedes the agreement between the Company and SMI previously signed on August 21, 2021.

Guided Therapeutics, Inc. or the “Company” (OTCQB: GTHP), the maker of LuViva, a rapid and painless cervical cancer detection system based on the Company’s patented biophotonic technology, announced today it had executed a Clinical Trial Agreement with a prestigious academic medical institution. The clinical trial is aimed at achieving FDA approval for LuViva and is expected to involve approximately 400 women at up to three medical institutions.

Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, announced today that the clinical trial for Chinese regulatory is back on track after experiencing delays due to Covid-19 lockdowns and is expected to be completed and filed with the Chinese National Medical Products Administration (NMPA) during the first half of 2023.

Guided Therapeutics, Inc. or the “Company” (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced today that it had raised approximately $3.3 million through the sale of 6.6 million shares of the Company’s common stock at 50 cents each. For each common share purchased, the investors also will receive one warrant to purchase an additional share for 50 cents and one warrant to purchase an additional share for 65 cents. Both warrants have a term of four years. If the shares are registered within six months, the warrants will not have a cashless exercise option and they do not carry any anti-dilution features. Investors include certain members of the Company’s board and other long term investors.

Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform for cervical cancer detection based on its patented biophotonic technology, announced that it has obtained Institutional Review Board (IRB) approval to initiate its clinical trial aimed at obtaining FDA approval for the Company’s flagship product, the LuViva Advanced Cervical Scan.

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.

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.

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 completed this year or early next year. Participating hospitals include Fudan University Hospital, Qilu Hospital of Shandong University and Peking University People’s Hospital. The physicians testing LuViva at these institutions represent the leadership of the Chinese obstetrics and gynecology community and include Professor Dr. Wei Lihui of Peking University and Dr. Kong Beihua of Qilu Hospital. Dr. Wei is former National Chairwoman of the Chinese Society of Obstetrics and Gynecology and Dr. Kong is currently the vice chairman of the Chinese Society of Obstetrics and Gynecology.

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.

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 addition, the confidence that a negative LuViva result truly indicated no significant disease (negative predictive value) was 90% for LuViva and 81% for HPV. The confidence that a positive test result truly indicated presence of disease (positive predictive value) was about the same for both LuViva (35%) and HPV (37%). According to new U.S. guidelines, women with this high a likelihood of cervical disease or higher need to either have tissue removed for a definitive diagnosis or consider immediate treatment. In contrast to HPV testing, LuViva does not require a costly and time-consuming lab infrastructure and provides results immediately as opposed to the delay of several days for lab tests such as the Pap or HPV. The study was conducted by a team led by Prof. Dr. Zoltan Hernadi at the Department of Obstetrics and Gynecology at the University of Debrecen, Hungary.

Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva™ Advanced Cervical Scan, based on its patented biophotonic technology, announced today its Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI), has received notice from the Jinan Medical Device Quality Supervision and Testing Center of the State Food and Drug Administration that LuViva has passed safety and electromagnetic compliance requirements necessary to be used in clinical trials. The clinical trials are expected to begin this quarter and SMI estimates that Chinese FDA approval and initial sales in China will occur in the second half of 2022. SMI reports that it has signed sub-distributor contracts for three provinces in expectation of Chinese FDA approval next year.

Guided Therapeutics, Inc. or the “Company” (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced today that it has raised an additional US $1.13 million under the terms of a 3-year convertible debenture. The proceeds are intended to pay off an existing convertible note that matures at the end of 2021. The convertible note that is being repaid included a highly dilutive discounted variable conversion mechanism based on the trading price of our common stock over the term of the note. In contrast, the new debenture has a fixed conversion price of $0.50. As a result, if converted, the new debenture will result in significantly less dilution than that produced by the retired note. Aspen Capital and Fieldhouse Capital Management advised the company for this financing.