Guided Therapeutics Files Pre-Submission Document
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Posted On: 02/18/2020 10:06:11 AM
Guided Therapeutics Files Pre-Submission Document with U.S. FDA Detailing Clinical Plan to Support Approval
February 18, 2020
Guided Therapeutics Files Pre-Submission Document with U.S. FDA Detailing Clinical Plan to Support Approval
Contacts
Mark Faupel
Guided Therapeutics
770-242-8723
Extension 303
Guided Therapeutics, Inc. (Pink Sheets: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, announced today it had achieved significant progress with the U.S. FDA in restarting its efforts for sales and marketing approval of its LuViva Advanced Cervical Scan. After a succession of conference calls, emails and letters exchanged with FDA over the past 30 days, the Company was encouraged by the agency to file a Pre-submission document detailing its approach for a new clinical trial to support U.S. approval. The Company filed Pre-Submission document with FDA on February 17, 2020. The Pre-submission document is designed to elicit comment from FDA regarding the clinical trial so that a study protocol can be completed and the clinical trial started.
“We have been pleased by FDA’s rapid responses to our plan for moving ahead with the approval process, which has allowed us to complete the initial phases of the study design ahead of schedule,” said Gene Cartwright, CEO. “If our plan is accepted by FDA, we expect to complete and file the study protocol for comment within about 30 to 60 days, depending on how rapidly FDA responds to our recently filed Pre-submission document.”
About Guided Therapeutics
Guided Therapeutics, Inc. (Pink Sheets: 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, 2018 and subsequent filings.
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February 18, 2020
Guided Therapeutics Files Pre-Submission Document with U.S. FDA Detailing Clinical Plan to Support Approval
Contacts
Mark Faupel
Guided Therapeutics
770-242-8723
Extension 303
Guided Therapeutics, Inc. (Pink Sheets: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, announced today it had achieved significant progress with the U.S. FDA in restarting its efforts for sales and marketing approval of its LuViva Advanced Cervical Scan. After a succession of conference calls, emails and letters exchanged with FDA over the past 30 days, the Company was encouraged by the agency to file a Pre-submission document detailing its approach for a new clinical trial to support U.S. approval. The Company filed Pre-Submission document with FDA on February 17, 2020. The Pre-submission document is designed to elicit comment from FDA regarding the clinical trial so that a study protocol can be completed and the clinical trial started.
“We have been pleased by FDA’s rapid responses to our plan for moving ahead with the approval process, which has allowed us to complete the initial phases of the study design ahead of schedule,” said Gene Cartwright, CEO. “If our plan is accepted by FDA, we expect to complete and file the study protocol for comment within about 30 to 60 days, depending on how rapidly FDA responds to our recently filed Pre-submission document.”
About Guided Therapeutics
Guided Therapeutics, Inc. (Pink Sheets: 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, 2018 and subsequent filings.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200218005316/en/
News powered by iR Direct — Copyright © 2020 Issuer Direct Corporation.
All Rights Reserved.
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