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Guided Therapeutics Inc. (GTHP) is a pioneering medical technology company focused on improving women's healthcare. The company is primarily known for its development of the LuViva® Advanced Cervical Scan, a non-invasive device designed for the early detection of cervical disease, including pre-cancerous conditions. This innovative technology aims to provide more accurate and immediate results compared to traditional Pap smears and HPV tests.
Guided Therapeutics is headquartered in Peachtree Corners, Georgia, and has established significant partnerships to enhance its research and development capabilities. Recently, the company has expanded its reach through various international collaborations, enabling broader access to its life-saving technology.
The financial health of Guided Therapeutics shows a commitment to continuous investment in R&D, ensuring they stay at the forefront of medical technology. Their product pipeline includes enhancements to the LuViva® system and other potential diagnostic tools that could revolutionize patient care.
The company's strategic vision emphasizes the importance of preventive healthcare, aiming to reduce the global burden of cervical cancer. With a solid foundation in medical research and a commitment to innovation, Guided Therapeutics Inc. is poised to make a significant impact on women's health worldwide.
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) announced that leading physicians from four major Chinese hospitals have concluded their review of the clinical study for the LuViva Advanced Cervical Scan. The study, involving approximately 460 women, reported no adverse events, underscoring the safety of LuViva. Led by Professor Dr. Kong Beihua and Dr. Sui Long, the results are expected to be filed with the Chinese National Medical Products Administration (NMPA) within four to five weeks. The physicians anticipate that the results, which are reportedly well above NMPA's expectations, will likely lead to approval for sale in China.
Guided Therapeutics (OTCQB: GTHP) has signed a new agreement with Shandong Yaohua Medical Instrument Corporation (SMI) in China, superseding a prior agreement from August 2021. The new deal includes two purchase orders totaling a minimum of $3,931,600 for goods and services. SMI commits to purchase approximately $40 million in the first year following approval by the National Medical Products Administration (NMPA). The clinical trial for NMPA approval is expected to complete mid-2023, with marketing approval anticipated by year-end. This agreement is expected to significantly boost revenue from China.
Guided Therapeutics (OTCQB: GTHP) has signed a Clinical Trial Agreement with a prominent academic medical institution to advance the FDA approval process for its cervical cancer detection device, LuViva. The trial will involve about 400 women across three sites, aiming to commence early next year and conclude by the end of 2023. LuViva utilizes patented biophotonic technology for rapid, non-invasive cervical disease detection, reportedly identifying issues two years earlier than traditional methods.
Guided Therapeutics (OTCQB: GTHP) has announced that its clinical trial for the LuViva Advanced Cervical Scan is back on track after delays due to Covid-19 lockdowns. The study is expected to be completed and submitted to the Chinese National Medical Products Administration (NMPA) in the first half of 2023. Current results indicate LuViva has met success criteria and is safe for nearly 200 women tested in China. The upcoming results will trigger a $2.5 million purchase order for LuViva devices and disposables from Shandong Yaohua Medical Instrument Corporation.
Guided Therapeutics (OTCQB: GTHP) raised approximately
Guided Therapeutics, Inc. (OTCQB: GTHP) has received Institutional Review Board (IRB) approval to launch a clinical trial for its LuViva Advanced Cervical Scan aimed at obtaining FDA approval. The trial is set to enroll up to approximately 400 women across key medical institutions, starting in 30 to 60 days. LuViva is already CE Mark-approved in the European Union and is undergoing trials in China. CEO Gene Cartwright noted that COVID-19 delays have impacted the trial's initiation.
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