April 30, 2020 Guided Therapeutics and FDA Meet;
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Posted On: 05/01/2020 1:10:14 AM
April 30, 2020
Guided Therapeutics and FDA Meet; Agree on Path Forward in Approval Process
Guided Therapeutics and FDA Meet; Agree on Path Forward in Approval Process
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 held a scheduled teleconference on April 28, 2020 with the US FDA as the next step for obtaining sales and marketing approval of its LuViva Advanced Cervical Scan. As a previous step, the Company filed on February 17, 2020 its FDA Pre-Submission document, which summarized LuViva’s new indication for use and supporting clinical trial design. Five days prior to its meeting, FDA provided the Company with written comments on its Pre-submission document detailing its approach for a new clinical trial to support U.S. approval.
“The meeting with FDA was both positive and constructive, providing a path forward in the approval process,” said Gene Cartwright, CEO. “With the aid of the written comments and feedback from the meeting, we expect to submit an improved study protocol within 30 days. At the same time, we also will begin the logistical work necessary for initiating the study.”
The new indication for LuViva’s use is based on recent findings that up to 40% to 50% of cervical disease can be missed at the point of biopsy because current technology of visually examining the cervix under magnification either cannot detect the correct area to biopsy or cannot detect the disease at all, even though a screening test such as the Pap Smear indicates an abnormality may exist. Our study is intended to demonstrate that LuViva can significantly increase disease detection by identifying those women who actually have, and should be treated for, the precursors of cervical cancer. Previous studies from U.S. and other countries indicate that LuViva can alert physicians and their patients to the presence of cervical disease even when conventional tests miss it.
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, 2019 and subsequent filings.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200430005596/en/
Guided Therapeutics and FDA Meet; Agree on Path Forward in Approval Process
Guided Therapeutics and FDA Meet; Agree on Path Forward in Approval Process
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 held a scheduled teleconference on April 28, 2020 with the US FDA as the next step for obtaining sales and marketing approval of its LuViva Advanced Cervical Scan. As a previous step, the Company filed on February 17, 2020 its FDA Pre-Submission document, which summarized LuViva’s new indication for use and supporting clinical trial design. Five days prior to its meeting, FDA provided the Company with written comments on its Pre-submission document detailing its approach for a new clinical trial to support U.S. approval.
“The meeting with FDA was both positive and constructive, providing a path forward in the approval process,” said Gene Cartwright, CEO. “With the aid of the written comments and feedback from the meeting, we expect to submit an improved study protocol within 30 days. At the same time, we also will begin the logistical work necessary for initiating the study.”
The new indication for LuViva’s use is based on recent findings that up to 40% to 50% of cervical disease can be missed at the point of biopsy because current technology of visually examining the cervix under magnification either cannot detect the correct area to biopsy or cannot detect the disease at all, even though a screening test such as the Pap Smear indicates an abnormality may exist. Our study is intended to demonstrate that LuViva can significantly increase disease detection by identifying those women who actually have, and should be treated for, the precursors of cervical cancer. Previous studies from U.S. and other countries indicate that LuViva can alert physicians and their patients to the presence of cervical disease even when conventional tests miss it.
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, 2019 and subsequent filings.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200430005596/en/
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