Guided Therapeutics（GTHP）株式概要ガイデッド・セラピューティクス社は医療技術企業で、医療機器の開発を行っている。 詳細GTHP ファンダメンタル分析スノーフレーク・スコア評価0/6将来の成長0/6過去の実績0/6財務の健全性0/6配当金0/6リスク分析キャッシュランウェイが1年未満である マイナスの株主資本 収益が 100 万ドル未満 ( $767K )過去5年間で収益は年間8.8%減少しました。 +3 さらなるリスクすべてのリスクチェックを見るGTHP Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair ValueUS$Current PriceUS$0.20297.5% 割高 内在価値ディスカウントEst. Revenue$PastFuture-10m6m2016201920222025202620282031Revenue US$5.8mEarnings US$738.9kAdvancedSet Fair ValueView all narrativesGuided Therapeutics, Inc. 競合他社SeaStar Medical HoldingSymbol: NasdaqCM:ICUMarket cap: US$11.2mQT Imaging HoldingsSymbol: NasdaqCM:QTIMarket cap: US$49.7mBeyond AirSymbol: NasdaqCM:XAIRMarket cap: US$5.1mSolanaSymbol: NasdaqCM:HSDTMarket cap: US$86.4m価格と性能株価の高値、安値、推移の概要Guided Therapeutics過去の株価現在の株価US$0.2052週高値US$0.5452週安値US$0.12ベータ0.731ヶ月の変化-7.84%3ヶ月変化-30.09%1年変化1.38%3年間の変化13.59%5年間の変化-62.80%IPOからの変化-99.90%最新ニュースお知らせ • Dec 18Guided Therapeutics, Inc. Announces Preliminary Findings from Its FDA Pivotal Clinical TrialGuided 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.お知らせ • Aug 14Guided Therapeutics Provides Update on Completion of US FDA Clinical TrialGuided 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.お知らせ • Jul 10Guided Therapeutics, Inc. Announces Data from Chinese Nmpa Clinical Study Signed Off by All Four Clinical Sites with Better Than Expected ResultsGuided 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.” .お知らせ • Nov 21Guided Therapeutics Announces Completion of Clinical Study for Chinese Regulatory ApprovalGuided 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.お知らせ • Dec 22Guided Therapeutics Signs Agreement to Begin Clinical Trial for US FDA ApprovalGuided 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.お知らせ • Nov 10Guided Therapeutics Provides Update of Significant Progress in Chinese Clinical Study for Marketing Approval of the LuViva Advanced Cervical ScanGuided 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.最新情報をもっと見るRecent updatesお知らせ • Dec 18Guided Therapeutics, Inc. Announces Preliminary Findings from Its FDA Pivotal Clinical TrialGuided 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.お知らせ • Aug 14Guided Therapeutics Provides Update on Completion of US FDA Clinical TrialGuided 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.お知らせ • Jul 10Guided Therapeutics, Inc. Announces Data from Chinese Nmpa Clinical Study Signed Off by All Four Clinical Sites with Better Than Expected ResultsGuided 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.” .お知らせ • Nov 21Guided Therapeutics Announces Completion of Clinical Study for Chinese Regulatory ApprovalGuided 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.お知らせ • Dec 22Guided Therapeutics Signs Agreement to Begin Clinical Trial for US FDA ApprovalGuided 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.お知らせ • Nov 10Guided Therapeutics Provides Update of Significant Progress in Chinese Clinical Study for Marketing Approval of the LuViva Advanced Cervical ScanGuided 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.お知らせ • Jul 21Guided Therapeutics, Inc. Receives Institutional Review Board Approval to Start Clinical Study for FDA Approval of the LuViva® Advanced Cervical ScanGuided 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.お知らせ • Apr 01Guided Therapeutics, Inc. Announces Testing Completion of First 150 Patients in Chinese Clinical Study and Receives Milestone Payment of $177,740Guided 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.お知らせ • Aug 17Guided Therapeutics, Inc. announced delayed 10-Q filingOn 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.お知らせ • Jun 04Guided Therapeutics, Inc. announced that it has received $1.13 million in fundingGuided 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.お知らせ • May 18Guided Therapeutics, Inc. announced delayed 10-Q filingOn 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.お知らせ • Apr 02Guided Therapeutics, Inc. announced delayed annual 10-K filingOn 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.お知らせ • Feb 18Guided Therapeutics, Inc. announced that it expects to receive $1.1 million in fundingGuided 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.お知らせ • Sep 17Guided Therapeutics, Inc. Appoints Richard P. Blumberg to the BoardOn 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.お知らせ • Aug 18Guided Therapeutics, Inc. announced delayed 10-Q filingOn 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.お知らせ • Jun 30Guided Therapeutics, Inc. announced delayed 10-Q filingOn 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.株主還元GTHPUS Medical EquipmentUS 市場7D-11.1%2.7%-4.1%1Y1.4%-20.8%20.6%株主還元を見る業界別リターン: GTHP過去 1 年間で-20.8 % の収益を上げたUS Medical Equipment業界を上回りました。リターン対市場: GTHPは、過去 1 年間で20.6 % のリターンを上げたUS市場を下回りました。価格変動Is GTHP's price volatile compared to industry and market?GTHP volatilityGTHP Average Weekly Movement22.2%Medical Equipment Industry Average Movement8.7%Market Average Movement7.2%10% most volatile stocks in US Market16.6%10% least volatile stocks in US Market3.1%安定した株価: GTHPの株価は、 US市場と比較して過去 3 か月間で変動しています。時間の経過による変動: GTHPの weekly volatility ( 22% ) は過去 1 年間安定していますが、依然としてUSの株式の 75% よりも高くなっています。会社概要設立従業員CEO（最高経営責任者ウェブサイト19923Mark Faupelwww.guidedinc.comGuided Therapeutics, Inc.は医療技術企業で、医療機器の開発を行っている。同社は、子宮頸部を光でスキャンし、反射光と蛍光光を分析することで、子宮頸がんおよび前がんを無痛、非侵襲的、かつポイントオブケアで識別する先進的な子宮頸スキャン非侵襲的子宮頸がん検出装置であるLuVivaのマーケティングおよび販売に注力している。同社は以前SpectRx, Inc.として知られていたが、2008年2月にGuided Therapeutics, Inc.に社名を変更した。Guided Therapeutics, Inc.は1992年に法人化され、ジョージア州ピーチツリーコーナーズに本社を置いている。もっと見るGuided Therapeutics, Inc. 基礎のまとめGuided Therapeutics の収益と売上を時価総額と比較するとどうか。GTHP 基礎統計学時価総額US$19.31m収益（TTM）-US$3.90m売上高(TTM)US$767.00k25.5xP/Sレシオ-5.0xPER（株価収益率GTHP は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計GTHP 損益計算書（TTM）収益US$767.00k売上原価US$196.00k売上総利益US$571.00kその他の費用US$4.47m収益-US$3.90m直近の収益報告Mar 31, 2026次回決算日該当なし一株当たり利益（EPS）-0.04グロス・マージン74.45%純利益率-507.95%有利子負債／自己資本比率-40.6%GTHP の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/06/10 11:00終値2026/06/10 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Guided Therapeutics, Inc. 0 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。0
お知らせ • Dec 18Guided Therapeutics, Inc. Announces Preliminary Findings from Its FDA Pivotal Clinical TrialGuided 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.
お知らせ • Aug 14Guided Therapeutics Provides Update on Completion of US FDA Clinical TrialGuided 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.
お知らせ • Jul 10Guided Therapeutics, Inc. Announces Data from Chinese Nmpa Clinical Study Signed Off by All Four Clinical Sites with Better Than Expected ResultsGuided 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.” .
お知らせ • Nov 21Guided Therapeutics Announces Completion of Clinical Study for Chinese Regulatory ApprovalGuided 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.
お知らせ • Dec 22Guided Therapeutics Signs Agreement to Begin Clinical Trial for US FDA ApprovalGuided 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.
お知らせ • Nov 10Guided Therapeutics Provides Update of Significant Progress in Chinese Clinical Study for Marketing Approval of the LuViva Advanced Cervical ScanGuided 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.
お知らせ • Dec 18Guided Therapeutics, Inc. Announces Preliminary Findings from Its FDA Pivotal Clinical TrialGuided 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.
お知らせ • Aug 14Guided Therapeutics Provides Update on Completion of US FDA Clinical TrialGuided 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.
お知らせ • Jul 10Guided Therapeutics, Inc. Announces Data from Chinese Nmpa Clinical Study Signed Off by All Four Clinical Sites with Better Than Expected ResultsGuided 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.” .
お知らせ • Nov 21Guided Therapeutics Announces Completion of Clinical Study for Chinese Regulatory ApprovalGuided 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.
お知らせ • Dec 22Guided Therapeutics Signs Agreement to Begin Clinical Trial for US FDA ApprovalGuided 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.
お知らせ • Nov 10Guided Therapeutics Provides Update of Significant Progress in Chinese Clinical Study for Marketing Approval of the LuViva Advanced Cervical ScanGuided 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.
お知らせ • Jul 21Guided Therapeutics, Inc. Receives Institutional Review Board Approval to Start Clinical Study for FDA Approval of the LuViva® Advanced Cervical ScanGuided 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.
お知らせ • Apr 01Guided Therapeutics, Inc. Announces Testing Completion of First 150 Patients in Chinese Clinical Study and Receives Milestone Payment of $177,740Guided 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.
お知らせ • Aug 17Guided Therapeutics, Inc. announced delayed 10-Q filingOn 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.
お知らせ • Jun 04Guided Therapeutics, Inc. announced that it has received $1.13 million in fundingGuided 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.
お知らせ • May 18Guided Therapeutics, Inc. announced delayed 10-Q filingOn 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.
お知らせ • Apr 02Guided Therapeutics, Inc. announced delayed annual 10-K filingOn 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.
お知らせ • Feb 18Guided Therapeutics, Inc. announced that it expects to receive $1.1 million in fundingGuided 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.
お知らせ • Sep 17Guided Therapeutics, Inc. Appoints Richard P. Blumberg to the BoardOn 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.
お知らせ • Aug 18Guided Therapeutics, Inc. announced delayed 10-Q filingOn 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.
お知らせ • Jun 30Guided Therapeutics, Inc. announced delayed 10-Q filingOn 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.
