Guided Therapeutics Provides Update on Start of Clinical Trial for US FDA Approval

May 1, 2023 |

3 min read

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, provided an update regarding the start of its pivotal clinical trial.

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, provided an update regarding the start of its pivotal clinical trial. The results of this clinical study will be used to support the Company’s application for U.S. FDA approval. The clinics involved in the study represent a mix of academic and community practices as well as representative population demographics. The first of the two academic centers opened for study recruitment in April and expects enrollment and testing to commence on their next colposcopy clinic scheduled for May 5^th. At the second academic center, all internal scientific and institutional review boards have approved the study and final preparations are being made to begin training there. The two community-based clinics have approved the study, signed clinical trial agreements, and are preparing to start the study. It is estimated that approximately 400 women will be tested. Additional information regarding the study can be found at Clinicaltrials.gov.

“We are extremely pleased to have four excellent clinical centers planning to enroll patients for our study,” said Mark Faupel, CEO of Guided Therapeutics. “We believe the addition of the two community clinics will shorten the timeline to completion of the study and provide us with a well-balanced and representative sample of the U.S. female population.”

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, 2022 and subsequent filings.