Guided Therapeutics Signs Agreement to Begin Clinical Trial for US FDA Approval

Rhea-AI Summary

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.

Positive

• Signed Clinical Trial Agreement to advance LuViva's FDA approval
• Trial involving approximately 400 women across multiple sites
• LuViva's technology demonstrates earlier cancer detection compared to traditional methods

Negative

• Regulatory approval for LuViva remains uncertain
• Risks associated with early commercialization and market acceptance of the device
• Dependence on licensed intellectual property and funding for development

PEACHTREE CORNERS, Ga.--(BUSINESS WIRE)-- Guided Therapeutics, Inc. or the “Company” (OTCQB: GTHP), the maker of LuViva, a rapid and painless cervical cancer detection system based on the Company’s patented biophotonic technology, announced today it had executed a Clinical Trial Agreement with a prestigious academic medical institution. The clinical trial is aimed at achieving FDA approval for LuViva and is expected to involve approximately 400 women at up to three medical institutions.

“Negotiating and signing the Clinical Trial Agreement is the final step prior to starting the study,” said Gene Cartwright, CEO of Guided Therapeutics. “We look forward to the start of the study early next year and planned completion before the end of 2023.”

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 orbital 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, 2021 and subsequent filings.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221221005021/en/

Mark Faupel

Guided Therapeutics

770-242-8723 ext. 303

Source: Guided Therapeutics, Inc.

FAQ

What is the purpose of the clinical trial for GTHP's LuViva?

The clinical trial aims to achieve FDA approval for LuViva, a cervical cancer detection system.

How many participants will be involved in the GTHP clinical trial?

Approximately 400 women will participate in the trial across up to three medical institutions.

When is the GTHP clinical trial expected to start?

The clinical trial is expected to begin early next year, with completion planned before the end of 2023.

What technology does GTHP's LuViva use?

LuViva employs patented biophotonic technology for the rapid and non-invasive detection of cervical disease.

What are the potential market impacts of GTHP's LuViva clinical trial results?

Successful trial results leading to FDA approval could significantly enhance market acceptance and sales of LuViva.