PEACHTREE CORNERS, Ga. - Guided Therapeutics, Inc. (OTCQB: GTHP), known for developing the LuViva Advanced Cervical Scan, has recently announced that its Chinese partner, Shandong Yaohua Medical Instrument Corporation (SMI), has submitted an application for the device to the Chinese National Medical Products Administration (NMPA). The application was supported by a study involving 449 women at four top medical institutions in China, yielding results that surpassed the study's success criteria.
The study highlighted LuViva's diagnostic performance, reporting a sensitivity of 83% for detecting cervical precancers and cancers, and a specificity of 54%. These metrics are particularly relevant as they measure the test's accuracy in correctly identifying individuals with the disease (true positives) and without the disease (true negatives). The findings suggest LuViva could improve cervical disease diagnosis and screening, potentially reducing unnecessary biopsies.
Mark Faupel, CEO of Guided Therapeutics, expressed optimism about the study's outcome and its implications for the ongoing US FDA study, which uses the same technology and artificial intelligence algorithms. The company is also anticipating a positive decision from the Chinese NMPA, which could significantly impact its market presence in China.
The NMPA filing also solidifies the partnership between Guided Therapeutics and SMI, setting the stage for a projected $125 million in revenue from devices, disposables, services, and royalties over the next six years.
Guided Therapeutics specializes in biophotonic technology for early disease detection at the cellular level. Their LuViva Advanced Cervical Scan is a non-invasive device designed to detect cervical disease instantly and at the point of care. Although currently considered an investigational device in the U.S., LuViva has shown promise in clinical trials for early detection of cervical cancer.
This announcement is based on a press release statement and does not endorse the claims made about LuViva's effectiveness. The product's approval and market acceptance are subject to regulatory review and competitive market conditions.
InvestingPro Insights
As Guided Therapeutics (OTCQB: GTHP) makes strides with its LuViva Advanced Cervical Scan in China, investors may be interested in the company's financial health and market performance. According to InvestingPro data, GTHP has a market capitalization of $9.74 million, reflecting its status as a small-cap company in the medical devices sector.
The company's recent progress in China aligns with an InvestingPro Tip indicating a significant return over the last week, with a 14.2% price increase. This short-term gain is part of a broader positive trend, as GTHP has seen a strong 45.45% return over the last three months and an impressive 75.82% surge over the past six months.
However, it's important to note that GTHP is not currently profitable, with a negative P/E ratio of -3.85 for the last twelve months as of Q2 2024. This reflects the company's developmental stage and its focus on gaining regulatory approvals and market access for LuViva.
Investors should be aware that GTHP's stock generally trades with high price volatility, which is typical for small biotech companies awaiting regulatory decisions. The potential $125 million in projected revenue over the next six years from the Chinese market could significantly impact the company's financial outlook if realized.
For those seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for GTHP, providing deeper insights into the company's financial position and market potential.
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