Guided Therapeutics Receives Institutional Review Board Approval to Start Clinical Study for FDA Approval of the LuViva® Advanced Cervical Scan

Rhea-AI Summary

Guided Therapeutics, Inc. (OTCQB: GTHP) has received Institutional Review Board (IRB) approval to launch a clinical trial for its LuViva Advanced Cervical Scan aimed at obtaining FDA approval. The trial is set to enroll up to approximately 400 women across key medical institutions, starting in 30 to 60 days. LuViva is already CE Mark-approved in the European Union and is undergoing trials in China. CEO Gene Cartwright noted that COVID-19 delays have impacted the trial's initiation.

Positive

• IRB approval received for LuViva clinical trial.
• Study to enroll approximately 400 women, enhancing potential market data.
• LuViva already has CE Mark approval, indicating regulatory progress.

Negative

• COVID-19 surges have delayed the study start.
• Uncertainty regarding market acceptance and regulatory approval.

PEACHTREE CORNERS, Ga.--(BUSINESS WIRE)-- Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform for cervical cancer detection based on its patented biophotonic technology, announced that it has obtained Institutional Review Board (IRB) approval to initiate its clinical trial aimed at obtaining FDA approval for the Company’s flagship product, the LuViva Advanced Cervical Scan.

The study protocol has been approved by WCG IRB, a leader in quality ethical review with over 50 years of experience and their approval is accepted by multiple clinical sites including the two key centers that have agreed to participate in the LuViva study. Both of these centers have enough patient volume to provide the number of patients required by FDA, projected to be up to approximately 400 women. The study is expected to start enrolling patients in about 30 to 60 days.

LuViva is already approved for sale in the European Union under the CE Mark and currently is undergoing clinical trials in China for National Medical Products Administration approval, China’s equivalent of the U.S FDA.

“Multiple COVID-19 surges have had a significant impact on the start of our study, as it has for most non-COVID related products,” said Gene Cartwright, CEO of Guided Therapeutics. “We are extremely gratified to have received a blanket IRB approval from WCG IRB that allows us to begin our study at prestigious medical institutions that are excited to be working with LuViva.”

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, 2021 and subsequent filings.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220720005063/en/

Mark Faupel

Guided Therapeutics

770-242-8723

Source: Guided Therapeutics, Inc.

FAQ

What clinical trial is Guided Therapeutics conducting for GTHP?

Guided Therapeutics is initiating a clinical trial for LuViva Advanced Cervical Scan to obtain FDA approval.

When will the clinical trial for LuViva start enrolling patients?

Patient enrollment for the LuViva study is expected to start in 30 to 60 days.

What is the purpose of the LuViva clinical trial?

The trial aims to validate LuViva's effectiveness for cervical cancer detection in order to secure FDA approval.

What regulatory approvals does LuViva currently have?

LuViva is CE Mark-approved for sale in the European Union and is undergoing trials for approval in China.

How many patients will be involved in the LuViva clinical trial?

The LuViva clinical trial is projected to involve up to approximately 400 women.