Guided Therapeutics, Inc. To File Amended PMA Application For Cervical Scanner
5/14/2014 8:01:04 AM
Guided Therapeutics Set to File Amended PMA Application for LuViva® Advanced Cervical Scan After “Productive” Face-to-Face Meeting with FDA
NORCROSS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced that as a result of its “productive” discussion with officials of the U.S. Food and Drug Administration (FDA) last week, the Company plans to submit an amendment to its premarket approval (PMA) application for the LuViva® Advanced Cervical Scan. The filing will include responses to questions raised in the agency’s September 6, 2013 not-approvable letter.
“The purpose of the meeting was to present the agency with our proposed answers to questions raised by FDA in the September letter and to help clarify our final responses,” said Gene Cartwright, Chief Executive Officer of Guided Therapeutics. “The meeting was constructive and we were able to put forward our logic and arguments and engage in a detailed discussion with the FDA. We will incorporate our responses and FDA feedback into our formal response, which we plan to file within the next 45 days.”
Once submitted, the FDA will have 180 days to respond to the company’s submission. Additional dialogue with FDA is expected as the company proceeds toward PMA approval.
Guided Therapeutics has regulatory approval to sell LuViva in Europe with the Edition 3 CE mark, has marketing approvals from Health Canada and Singapore Health Sciences Authority and has filed for approval in Mexico.
About LuViva® Advanced Cervical Scan
LuViva is a technologically advanced diagnostic device that scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue. Spectroscopy identifies chemical and structural indicators of precancer that may be below the surface of the cervix or misdiagnosed as benign. This technique is called biophotonics. Unlike Pap, HPV tests or biopsies, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which eliminates costly, painful and unnecessary testing. LuViva is designed for use with women who have undergone initial screening and are called back for follow up with a colposcopy examination, which in many cases, involves taking a biopsy of the cervix. The device is used in conjunction with the LuViva® Cervical Guide single-use patient interface and calibration disposable.
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCBB: GTHP) (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. Guided Therapeutics is also developing a non-invasive test for the early detection of esophageal cancer using the technology platform. 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. 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 products in development, 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 uncertainty of capital to develop products, the uncertainty of regulatory approval of products, 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, 2013, and subsequent quarterly reports.
Bill Wells, 770-242-8723
Alison Ziegler, 212-554-5469
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