Tillkännagivande • Jun 16
Guided Therapeutics Files Premarket Approval Application Clinical Report with FDA Guided Therapeutics, Inc. filed the results of its multicenter clinical trial with the U.S. Food and Drug Administration (FDA). The study protocol was developed through interactions with FDA and enrolled 480 women referred to biopsy because of abnormal Pap and/or HPV tests. Of the 428 women that completed the study, 99 were determined by expert independent pathology to have significant cervical disease that can lead to cancer, and of these, 32 cases of disease (32.3%) went undetected by the current standard of care consisting of colposcopy-directed biopsy. The primary goal of the study was to show that LuViva could detect a significant number of these “missed” precancerous lesions. The results showed that LuViva detected 21 of the 32 (66%) disease cases that were missed by the current standard of care, increasing the detection rate from 68% without LuViva to 89% with LuViva. Moreover, all primary and secondary endpoints regarding the sensitivity and specificity of LuViva were met with a high degree of statistical certainty (p < 0.0001). There were no safety issues or adverse events related to LuViva reported among the study participants. Tillkännagivande • Dec 18
Guided Therapeutics, Inc. Announces Preliminary Findings from Its FDA Pivotal Clinical Trial Guided Therapeutics, Inc. announced that preliminary findings from its FDA pivotal clinical trial demonstrate that there is a strong clinical need for LuViva's ability to detect cases of cervical precancer and cancer currently missed by the standard of care. Specifically, the study's preliminary results show that current practice fails to detect a substantial percentage of early cervical precancers for women referred to biopsy based on abnormal Pap and/or HPV results. Thus far, preliminary analyses based on each patient's clinical site pathology findings show that 24 of 97 cases of disease (25%) were missed by the current standard of care. Previous studies have shown that LuViva detects the majority of early precancers and cancers, which augers well for meeting the study's primary goal. To reach a final diagnosis for each patient, pathology results also include diagnoses made by independent expert pathologists. The completed study includes approximately 480 enrolled subjects, of whom over 420 will be evaluated for efficacy. Both these numbers meet criteria set forth in the study protocol reviewed by FDA prior to the start of the study. All study sites are closed and monitoring completed. Final clinical results are expected to be filed with FDA within about 30 to 60 days. Tillkännagivande • Aug 14
Guided Therapeutics Provides Update on Completion of US FDA Clinical Trial Guided Therapeutics, Inc. announced 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. Tillkännagivande • Jul 10
Guided Therapeutics, Inc. Announces Data from Chinese Nmpa Clinical Study Signed Off by All Four Clinical Sites with Better Than Expected Results Guided Therapeutics, Inc. announced that leading physicians from four 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.” . Tillkännagivande • Nov 21
Guided Therapeutics Announces Completion of Clinical Study for Chinese Regulatory Approval Guided Therapeutics, Inc. announced 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. The Company's Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI) intends to analyze the study results with the participating doctors and file them with the NMPA within the next 90 days. The filing triggers purchase order payments to Guided Therapeutics of approximately $2.2 Million, with additional significant orders for devices and disposables in 2024 and beyond. Tillkännagivande • Dec 22
Guided Therapeutics Signs Agreement to Begin Clinical Trial for US FDA Approval Guided Therapeutics, Inc. announced 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. Tillkännagivande • Nov 10
Guided Therapeutics Provides Update of Significant Progress in Chinese Clinical Study for Marketing Approval of the LuViva Advanced Cervical Scan Guided Therapeutics, Inc. announced 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. According to Guided Therapeutics Chinese partner, Shandong Yaohua Medical Instrument Corporation (SMI), the results so far indicate that LuViva meets or exceeds the success criteria as described in the current study protocol and has been demonstrated to be safe for use on nearly 200 women tested thus far in China. Hospitals participating in the study include Qilu Hospital of Shandong University, Fudan (Shanghai) University Hospital and Peking University People’s Hospital. According to the World Health Organization, cervical cancer is one of the most frequent cancers worldwide and is the second most common cancer among Chinese women. China has a population of approximately 560 million women above 15 years of age who are at risk of developing cervical cancer. Current estimates indicate approximately 100,000 new cases of cervical cancer are diagnosed each year and 30,000 deaths occur annually due to cervical cancer in China. Tillkännagivande • Jul 21
Guided Therapeutics, Inc. Receives Institutional Review Board Approval to Start Clinical Study for FDA Approval of the LuViva® Advanced Cervical Scan Guided Therapeutics, Inc. announced that it has obtained Institutional Review Board (IRB) approval to initiate its clinical trial aimed at obtaining FDA approval for the Company’s product, the LuViva Advanced Cervical Scan. The study protocol has been approved by WCG IRB, a leader in quality ethical review with over 50 years of experience and their approval is accepted by multiple clinical sites including the two key centers that have agreed to participate in the LuViva study. Both of these centers have enough patient volume to provide the number of patients required by FDA, projected to be up to approximately 400 women. The study is expected to start enrolling patients in about 30 to 60 days. LuViva is already approved for sale in the European Union under the CE Mark and currently is undergoing clinical trials in China for National Medical Products Administration approval, China’s equivalent of the U.S FDA. Tillkännagivande • Apr 01
Guided Therapeutics, Inc. Announces Testing Completion of First 150 Patients in Chinese Clinical Study and Receives Milestone Payment of $177,740 Guided Therapeutics, Inc. announced 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 distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI), made a scheduled milestone payment to the Company of $177,740. A portion of these funds will be used to supply SMI with LuViva devices and parts. According to SMI, both the interim safety and accuracy results of LuViva justify the completion of the clinical study and submission of the data to the NMPA as soon as practicable. Tillkännagivande • Aug 17
Guided Therapeutics, Inc. announced delayed 10-Q filing On 08/16/2021, Guided Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Tillkännagivande • Jun 04
Guided Therapeutics, Inc. announced that it has received $1.13 million in funding Guided Therapeutics, Inc. (OTCBB:GTHP) announced a private placement of a convertible debenture for gross proceeds of $1,130,000 on June 3, 2021. The note will have a term period of 3 years. The note carries fixed conversion price of $0.50 per note. The note will automatically convert into the shares in a subsequent financing if that financing is undertaken in connection with an uplisting to Nasdaq. Tillkännagivande • May 18
Guided Therapeutics, Inc. announced delayed 10-Q filing On 05/17/2021, Guided Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Tillkännagivande • Apr 02
Guided Therapeutics, Inc. announced delayed annual 10-K filing On 03/31/2021, Guided Therapeutics, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Tillkännagivande • Feb 18
Guided Therapeutics, Inc. announced that it expects to receive $1.1 million in funding Guided Therapeutics, Inc. (OTCPK:GTHP) announced a private placement of series F preferred stock for the gross proceeds of $1.1 million on February 16, 2021. The series F preferred shares are convertible at a fixed price of $0.25 per share, carry a 6% annual dividend and could potentially include an additional dividend of 15% after twelve months if the company is unable to uplist to a national exchange or complete its FDA study. The dividends can be paid in cash or common shares at the option of the company. The transaction is targeted at least $1 million and the financing can continue to raise additional funds until closing this tranche, forecast for later this month. Tillkännagivande • Sep 17
Guided Therapeutics, Inc. Appoints Richard P. Blumberg to the Board On September 1, 2020, the board of directors of Guided Therapeutics, Inc. increased the size of the board from four members to five and appointed Richard P. Blumberg to fill the newly created vacancy. Mr. Blumberg has been a long-time investor in the Company. Since 1978, Mr. Blumberg has been a Principal at Webster, Mrak & Blumberg, a medical-legal and class action labor litigation firm. He is also currently a Managing Member of K2 Medical, LLC formerly known as Shenghuo Medical, LLC (“Shenghuo”), a company with licensing rights in several Asian countries for the Company’s LuViva Advanced Cervical Scan, and is a Managing Member of Elysian Medical, LLC, a company with world-wide rights for certain breast cancer detection technology. He served from 2004 to 2007 as Chief Executive Officer of Energy Logics, a wind power company that developed projects in Alberta, Canada and Montana. Mr. Blumberg holds a B.S. in Electrical Engineering and Computer Science from the University of Illinois and received a J. D. from Stanford University. He also brings extensive experience as a venture capitalist specializing in high-tech and life science companies. Tillkännagivande • Aug 18
Guided Therapeutics, Inc. announced delayed 10-Q filing On 08/17/2020, Guided Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Tillkännagivande • Jun 30
Guided Therapeutics, Inc. announced delayed 10-Q filing On 06/29/2020, Guided Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. 
