$GTHP $0.18
My Opinion
The PR below speaks for itself. The original due date based on the FDA 180 day deadline was January 24th.
If the FDA wasn't seriously considering approval they would have canned this by now.
There are only 59 million shares in the float, so it should move very well with approval. Any other information would be all speculation. But personally, I think it's possibly very explosive with approval.
They have been working on this product for 15 years, it will truly revolutionize OBGYN visits for women eliminating the Pap Smear. (ask your woman how much she loves having a Pap Smear and how much she would like a scanner that can detect precancerous cells up to 2 years earlier). One of these scanners in every OBGYN Office is a gold mine! It's already approved in other countries.
It traded up close to $2/share in 2011
This is my largest position in my whole portfolio and I have MANY positions right now. FYI and GLTA
Guided Therapeutics Provides an Update on FDA Review Time for LuViva® Advanced Cervical Scan
Date : 02/03/2015 @ 8:05AM
Source : Business Wire
Stock : Guided Therapeutics, Inc. (QB) (GTHP)
Quote : 0.193 0.0031 (1.63%) @ 9:58AM
Guided Therapeutics Provides an Update on FDA Review Time for LuViva® Advanced Cervical Scan
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Guided Therapeutics, Inc. (QB) (OTCBB:GTHP)
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Today : Tuesday 3 February 2015
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Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced that the U.S. Food and Drug Administration (FDA) has not yet completed its review of the pre-market approval (PMA) application for the LuViva® Advanced Cervical Scan. The company has been in communication with the agency and is hoping to receive the agency’s decision within the next several weeks.
“We continue to believe our PMA amendment addressed the remaining questions the agency had and remain hopeful the FDA will find a pathway forward for LuViva,” said Gene Cartwright, Chief Executive Officer of Guided Therapeutics.
Mr. Cartwright added, “Importantly, the review timeline by the FDA does not impact the ability of our distributors to continue to sell LuViva internationally. We continue to see momentum building in the larger international market. We expect to see solid demand from Latin America, South Asia and Africa in 2015 where our distributors are working with federal and local governments for orders.”
The Company anticipates providing sales guidance for the upcoming year in March 2015 when it reports its results for the year ended December 31, 2014.
The Company currently has regulatory approval to sell LuViva in Europe with the Edition 3 CE mark, and has marketing approvals from COFEPRIS in Mexico, Health Canada and Singapore Health Sciences Authority, among others. Additionally, expansion efforts are ongoing in the Middle East, Asia and Latin America.
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 may result in eliminating costly, painful and unnecessary additional testing. LuViva is intended 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. It has also been used in clinical studies in Turkey and Nigeria as a means to screen women for cervical cancer where the availability of infrastructure necessary for Pap and HPV testing is restricted. 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. 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.
Guided Therapeutics
Bill Wells, 770-242-8723
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Investor Relations:
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Alison Ziegler, 212-554-5469
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