Guided Therapeutics Continues FDA Progress and Schedules Key Meeting to Finalize Clinical Study Protocol for the LuViva® Advanced Cervical Scan
August 27, 2020
Contacts
Mark Faupel
Guided Therapeutics
770-242-8723
Extension 303
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, announced that it will meet with the FDA to finalize the protocol for its clinical study in support of its Premarketing Application for the LuViva® Advanced Cervical Scan. The meeting has been set for October 14, 2020. The FDA already has provided the Company with guidance for drafting the study protocol through useful feedback on the Company’s Pre-submission documents and its previous meeting with the FDA.
To gear up for the clinical study, the Company is interviewing potential clinical sites. The study plans to enroll patients at four clinical sites that represent a cross section of the U.S. population of women who are screened for cervical cancer. Because of limitations inherent in current imaging technology, as much as 40% to 50% of disease is missed, even with invasive and expensive biopsy. Under the draft protocol submitted to FDA for review, LuViva will be studied to document its ability to detect a significant number of these missed diagnoses. New national guidelines for cervical cancer management published in April of 2020 stress a preferred risk-based approach, a primary feature of LuViva’s AI-based risk profile algorithms.
“Once FDA has completed the review of the study protocol, we intend to begin enrolling patients as soon as practicable,” said Gene Cartwright, CEO. “Starting our study will be major milestone for the Company’s plans to commercialize LuViva in the U.S.”
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, 2019 and subsequent filings.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200827005420/en/
August 27, 2020
Contacts
Mark Faupel
Guided Therapeutics
770-242-8723
Extension 303
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, announced that it will meet with the FDA to finalize the protocol for its clinical study in support of its Premarketing Application for the LuViva® Advanced Cervical Scan. The meeting has been set for October 14, 2020. The FDA already has provided the Company with guidance for drafting the study protocol through useful feedback on the Company’s Pre-submission documents and its previous meeting with the FDA.
To gear up for the clinical study, the Company is interviewing potential clinical sites. The study plans to enroll patients at four clinical sites that represent a cross section of the U.S. population of women who are screened for cervical cancer. Because of limitations inherent in current imaging technology, as much as 40% to 50% of disease is missed, even with invasive and expensive biopsy. Under the draft protocol submitted to FDA for review, LuViva will be studied to document its ability to detect a significant number of these missed diagnoses. New national guidelines for cervical cancer management published in April of 2020 stress a preferred risk-based approach, a primary feature of LuViva’s AI-based risk profile algorithms.
“Once FDA has completed the review of the study protocol, we intend to begin enrolling patients as soon as practicable,” said Gene Cartwright, CEO. “Starting our study will be major milestone for the Company’s plans to commercialize LuViva in the U.S.”
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, 2019 and subsequent filings.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200827005420/en/
