Guided Therapeutics Receives May 8th Meeting Date from FDA to Discuss LuViva® Advanced Cervical Scan PMA Application

  Guided Therapeutics Receives May 8th Meeting Date from FDA to Discuss
  LuViva® Advanced Cervical Scan PMA Application

Business Wire

NORCROSS, Ga. -- April 10, 2014

Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced that the
company has been given a face-to-face meeting date of May 8, 2014, by the U.S.
Food and Drug Administration (FDA), to discuss the company’s response to the
September 6, 2013 not-approvable letter that the company received from the
agency.

“These face-to-face meetings are an important part of advancing the review
process and we are pleased that the FDA has responded so quickly to our
request for the meeting,” said Gene Cartwright, Chief Executive Officer of
Guided Therapeutics. “After the meeting, we plan to submit our formal, written
response to questions in the September 6, 2013 letter.”

“Meanwhile, we continue to focus on growing sales for LuViva in international
markets and working to expand its application in developing countries to
include screening for cervical cancer,” Mr. Cartwright said.

The company 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. Additionally,
expansion efforts are ongoing in the Middle East, Asia, Africa 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 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.

Contact:

For Guided Therapeutics
Bill Wells, 770-242-8723
or
Investors:
Cameron Associates
Alison Ziegler, 212-554-5469
 
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