Guided Thera - GTHP STOCK NEWS

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, Inc. (GTHP) announces final stages of clinical data report for LuViva Advanced Cervical Scan approval in China. Expected approval by Chinese NMPA with positive feedback from prominent doctors. Commercialization payments from Chinese partner to exceed $4 million in 2024.

Guided Therapeutics, Inc. (OTCQB: GTHP) announced the completion of a clinical trial for marketing and sales approval of the LuViva Advanced Cervical Scan by the Chinese National Medical Products Administration (NMPA). The study, involving about 450 women, was conducted at prestigious medical institutions, including Shandong University, Fudan University, and Peking University. The study was led by prominent doctors, and the results will be filed with NMPA within the next 90 days, triggering purchase order payments to Guided Therapeutics of approximately $2.2 million, with more significant orders expected in 2024 and beyond.

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 $3.3 million by selling 6.6 million shares at 50 cents each. Each share purchase includes two warrants for future purchases at 50 cents and 65 cents. The funds will primarily be used for clinical study costs related to FDA approval of the LuViva Advanced Cervical Scan and to support international distribution. The company plans to maintain its Nasdaq uplisting application open, focusing on favorable market conditions. Existing investors participated in the funding under reasonable terms.