Guided Therapeutics Submits Request for Face to Face Meeting with FDA; Receives Notification on PMA Extension for LuViva®

  Guided Therapeutics Submits Request for Face to Face Meeting with FDA;
  Receives Notification on PMA Extension for LuViva® Advanced Cervical Scan

Business Wire

NORCROSS, Ga. -- March 27, 2014

Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced that the
company has submitted a letter requesting a face-to-face meeting with the U.S.
Food and Drug Administration (FDA) in the next 60 to 90 days. This letter is
in response to the September 6, 2013 letter that the company received from the
FDA. Additionally, the FDA has granted the company its requested 180 day
extension on the PMA filing to allow time for the meeting to occur.

“While we have drafted our responses to questions in the not approvable letter
received in September, we feel it is in our best interest to meet with FDA
before submission of the official response,” said Gene Cartwright, Chief
Executive Officer of Guided Therapeutics. “These face-to-face meetings are an
important part of advancing the approval process. The extension we received on
March 18 will enable both the company and FDA to prepare adequately in order
to make the most of the meeting.”

“While focusing on growing sales for our product in places like Canada,
Turkey, Europe and Africa, we remain confident in the potential of LuViva in
the U.S. market and remain committed to pursuing FDA approval,” 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:

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