Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today provided
anticipated sales results for its second quarter ended June 30, 2014 and
also provided updated timing regarding the submittal of its amendment to
its premarket approval (PMA) application for the LuViva® Advanced
For the second quarter of 2014, the Company anticipates reporting that
sales of LuViva reached $200,000, up over 60% from first quarter results
and in line with expectations of LuViva sales of $1.0 million to $3.0
million for the full year.
Regarding the amended PMA filing for LuViva, as previously stated, the
Company plans to file its amendment after the review of the consensus
minutes from the May 8 meeting with FDA, as well as a final review by
its FDA consultant. The company expects to receive this information late
this week or early next week.
"It is important to have agreement on statements made by FDA during our
face-to-face meeting in May," said Gene Cartwright, Chief Executive
Officer of Guided Therapeutics. "Given the information we currently
have, we anticipate filing with the FDA late in July."
Cartwright added, "In the meantime, international sales are progressing
as expected, with the Turkey Ministry of Health shipments resuming in
the second quarter. We continue to expect to build on these sales
results in the second half of the year and remain on track to hit our
annual revenue guidance."
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 cevical 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,
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.
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