Guided Therapeutics’ Announces Data from Chinese NMPA Clinical Study Signed Off by All Four Clinical Sites With Better Than Expected Results

Rhea-AI Summary

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.

Positive

• Four leading Chinese medical centers completed the review.
• Approximately 460 women were tested without adverse events.
• Study led by prominent experts, Professor Dr. Kong Beihua and Dr. Sui Long.
• Results expected to be well above NMPA's expectations.
• Filing with NMPA anticipated within four to five weeks.
• Potential approval for LuViva in the Chinese market.

Negative

• None.

PEACHTREE CORNERS, Ga.--(BUSINESS WIRE)-- Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, announced today that leading physicians from four prestigious 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.”

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 U.S. LuViva, the wave logo and "Early detection, better outcomes" are registered trademarks owned by Guided Therapeutics, Inc.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240710088176/en/

Mark Faupel

Guided Therapeutics

770-242-8723

Source: Guided Therapeutics, Inc.

FAQ

What recent clinical study did Guided Therapeutics complete for the LuViva Advanced Cervical Scan?

Guided Therapeutics completed a clinical study involving approximately 460 women at four major Chinese hospitals for the LuViva Advanced Cervical Scan.

Were there any adverse events reported in the LuViva clinical study?

No adverse events were reported during the clinical study of the LuViva Advanced Cervical Scan.

Who led the clinical study for LuViva in China?

The study was led by Professor Dr. Kong Beihua from Qilu Hospital at Shandong University and Dr. Sui Long, Director of the Gynecology Hospital at Fudan University.

When will the results of the LuViva study be filed with the NMPA?

The results are expected to be filed with the Chinese National Medical Products Administration (NMPA) within the next four to five weeks.

What are the expectations for the LuViva clinical study results?

The physicians believe the results are well above the expectations of the NMPA, potentially leading to approval for sale in China.