Guided Therapeutics Announces Filing of Application for NMPA Approval to Market and Sell LuViva in China
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.
Guided Therapeutics (OTCQB: GTHP) ha annunciato che il suo partner cinese, Shandong Yaohua Medical Instrument (SMI), ha presentato una domanda per il LuViva Advanced Cervical Scan all'Amministrazione Nazionale per i Prodotti Medici della Cina (NMPA). La domanda includeva i risultati di uno studio condotto su 449 donne in quattro importanti istituzioni mediche in Cina, mostrando una sensibilità del test dell'83% e una specificità del 54%, superando i criteri di successo richiesti.
I risultati dello studio supportano il potenziale utilizzo di LuViva nella diagnosi e nello screening delle malattie cervicali nelle fasi iniziali e trattabili. LuViva potrebbe aiutare 54% delle donne a evitare biopsie inutili con il 93% di fiducia nei risultati negativi. Come test di screening, la capacità dell'83% di LuViva di identificare casi di precancro di grado moderato e alto supera la media del 40%-50% dei test di Pap.
La presentazione all'NMPA prosegue la collaborazione tra Guided Therapeutics e SMI, con possibili traguardi e pagamenti che superano i 125 milioni di dollari in sei anni per dispositivi, consumabili, servizi e diritti d'autore.
Guided Therapeutics (OTCQB: GTHP) anunció que su socio chino, Shandong Yaohua Medical Instrument (SMI), ha presentado una solicitud para el LuViva Advanced Cervical Scan ante la Administración Nacional de Productos Médicos de China (NMPA). La solicitud incluyó los resultados de un estudio realizado con 449 mujeres en cuatro destacadas instituciones médicas en China, mostrando una sensibilidad del test del 83% y una especificidad del 54%, superando los criterios de éxito requeridos.
Los resultados del estudio respaldan el uso potencial de LuViva en el diagnóstico y la detección de enfermedades cervicales en sus primeras etapas tratables. LuViva podría ayudar a el 54% de las mujeres a evitar biopsias innecesarias con una confianza del 93% en los resultados negativos. Como test de detección, la capacidad del 83% de LuViva para identificar casos de precáncer de grado moderado y alto supera el promedio del 40%-50% de las pruebas de Pap.
La presentación ante la NMPA continúa la asociación entre Guided Therapeutics y SMI, con posibles hitos y pagos que superan los 125 millones de dólares en seis años por dispositivos, consumibles, servicios y regalías.
Guided Therapeutics (OTCQB: GTHP)는 중국 파트너인 산둥 야오화 의료기기(SMI)가 중국 국가 의료 제품 관리국(NMPA)에 LuViva Advanced Cervical Scan에 대한 신청서를 제출했다고 발표했습니다. 신청서에는 중국의 네 개 주요 의료 기관에서 449명의 여성에 대한 연구 결과가 포함되어 있으며, 검사 민감도가 83%이고 특이성은 54%로 필수 성공 기준을 초과했습니다.
연구 결과는 LuViva가 자궁경부 질병의 조기 치료 가능한 단계 진단 및 검진에 잠재적으로 사용될 수 있음을 지원합니다. LuViva는 54%의 여성들이 불필요한 생검을 피할 수 있도록 도울 수 있으며 음성 결과에 대해 93%의 신뢰도를 제공합니다. 선별 검사로서 LuViva의 83%는 중등도 및 고급 전암을 식별하는 능력으로, 파파니콜로 검사 평균인 40%-50%를 초과합니다.
NMPA 신청서는 Guided Therapeutics와 SMI 간의 파트너십을 이어가며, 기기, 소모품, 서비스 및 로열티를 위한 6년 동안 1억 2500만 달러를 초과하는 이정표 및 지급 가능성이 있습니다.
Guided Therapeutics (OTCQB: GTHP) a annoncé que son partenaire chinois, Shandong Yaohua Medical Instrument (SMI), a déposé une demande pour le LuViva Advanced Cervical Scan auprès de l'Administration nationale des produits médicaux de Chine (NMPA). La demande comprenait les résultats d'une étude de 449 femmes dans quatre grandes institutions médicales en Chine, montrant une sensibilité du test de 83% et une spécificité de 54%, dépassant les critères de succès requis.
Les résultats de l'étude soutiennent l'utilisation potentielle de LuViva dans le diagnostic et le dépistage des maladies cervicales à un stade précoce, traitable. LuViva pourrait aider 54% des femmes à éviter des biopsies inutiles avec une confiance de 93% dans les résultats négatifs. En tant que test de dépistage, LuViva est capable d'identifier à 83% les cas de précancer de grade modéré et élevé, surpassant la moyenne de 40%-50% des tests de Pap.
Le dépôt auprès de la NMPA poursuit le partenariat entre Guided Therapeutics et SMI, avec des jalons et des paiements potentiels dépassant 125 millions de dollars sur six ans pour les dispositifs, les consommables, les services et les redevances.
Guided Therapeutics (OTCQB: GTHP) gab bekannt, dass ihr chinesischer Partner, Shandong Yaohua Medical Instrument (SMI), einen Antrag für das LuViva Advanced Cervical Scan bei der chinesischen Nationalen Arzneimittelbehörde (NMPA) gestellt hat. Der Antrag beinhaltete die Ergebnisse einer Studie mit 449 Frauen in vier führenden medizinischen Einrichtungen in China, die eine Testempfindlichkeit von 83% und eine Spezifität von 54% zeigten, was die erforderlichen Erfolgsbedingungen übertrifft.
Die Studienergebnisse unterstützen das potenzielle Einsatzgebiet von LuViva zur Diagnose und zum Screening von Gebärmutterhalskrankheiten in den frühen, behandelbaren Stadien. LuViva könnte helfen, 54% der Frauen unnötige Biopsien zu vermeiden mit 93% Vertrauen in negative Ergebnisse. Als Screening-Test übertrifft die Fähigkeit von LuViva, 83% der moderaten und hochgradigen Präkanzer zu identifizieren, die durchschnittlichen 40%-50% der Pap-Tests.
Die Einreichung bei der NMPA setzt die Partnerschaft zwischen Guided Therapeutics und SMI fort, mit potenziellen Meilensteinen und Zahlungen von über 125 Millionen Dollar über einen Zeitraum von sechs Jahren für Geräte, Einwegartikel, Dienstleistungen und Lizenzgebühren.
- LuViva showed 83% sensitivity and 54% specificity in Chinese clinical study, exceeding required success criteria
- LuViva could help 54% of women avoid unnecessary biopsies with 93% confidence in negative results
- LuViva's 83% ability to identify precancer outperforms average Pap test performance of 40%-50%
- NMPA filing triggers partnership with SMI, potentially worth over $125 million in 6 years
- US FDA study for LuViva has enrolled more than half of the required patients
- None.
PEACHTREE CORNERS, Ga.--(BUSINESS WIRE)--
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
Sensitivity and specificity describe the accuracy of a test that reports the presence or absence of a disease, in this case cervical precancers and cancers. Individuals who have the disease are considered "positive" and those who do not are considered "negative". Sensitivity is a measure of how well a test can identify true positives and specificity is a measure of how well a test can identify true negatives.
The results of the study support the potential use of LuViva to both diagnose and screen for cervical disease when the disease can be treated effectively and economically, while in its earliest stages before it has become invasive. Firstly, due to the high false positive rates of Pap and HPV screening, only about
“Obviously, we are thrilled by the outcome of our Chinese study and look forward to working with SMI and the Chinese NMPA to help ensure speedy approval of our safe and effective technology,” said Mark Faupel, CEO of Guided Therapeutics. "Equally important, the results of the Chinese study are significant because they were produced by the same LuViva technology and AI based algorithms we are using for our current US FDA study, which has now enrolled more than half of the expected number of required patients.”
The filing with NMPA triggers the continuation of the working relationship between the Company and SMI, with milestones and minimum payments to GTI for devices, disposables, services and royalties of more than
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCQB: GTHP) is the maker of a rapid and painless testing platform based on its patented biophotonic technology that utilizes light for the early detection of disease at the cellular level. The Company’s first product is the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports. For more information, visit: www.guidedinc.com.
The Guided Therapeutics LuViva® Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use in the
Forward-Looking Statements Disclaimer: A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics’ actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include those related to the early stage of commercialization of products, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the sufficiency of capital raised in prior financings and the ability to realize their expected benefits, the uncertainty of future capital to develop products or continue as a going concern, the uncertainty of regulatory approval of products, and the dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading “Risk Factors” in Guided Therapeutics’ reports filed with the SEC, including Guided Therapeutics’ Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and subsequent filings.
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Mark Faupel
Guided Therapeutics
770-242-8723
Source: Guided Therapeutics, Inc.
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