SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of Earliest Event)
July 8, 2014; (July 2, 2014)
GUIDED THERAPEUTICS, INC.
(Exact Name of Registrant as Specified
in Its Charter)
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Delaware |
0-22179 |
58-2029543 |
(State or Other Jurisdiction of |
(Commission File Number) |
(IRS Employer Identification No.) |
Incorporation) |
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5835 Peachtree Corners East, Suite D
Norcross, Georgia
(Address of Principal Executive Offices) |
30092
(Zip Code) |
Registrant's Telephone Number, Including Area
Code: (770) 242-8723
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Section 7.01 (Regulation FD Disclosure)
On July 2, 2014, the registrant publicly
issued a press release announcing second quarter sales and providing an update on the FDA application for premarket approval for
the LuViva® Advanced Cervical Scan, as more fully described in the press release, a
copy of which is furnished as Exhibit 99.1 hereto and which information is incorporated herein by reference.
Item 9.01 Financial
Statements and Exhibits.
(d) Exhibits.
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Number |
Exhibit |
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99.1 |
Press Release dated July 2, 2014 |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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GUIDED THERAPEUTICS, INC. |
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By: |
/s/ Gene Cartwright |
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Gene Cartwright |
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Chief Executive Officer |
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Date: July 8, 2014 |
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Exhibit
99.1
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5835
Peachtree Corners East, Suite D |
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Norcross, GA
30092 |
FOR
IMMEDIATE RELEASE
Guided
Therapeutics Second Quarter Sales to Reach $200,000;
Update
Timing for Amended PMA Application for LuViva® Advanced Cervical Scan
NORCROSS,
GA (July 2, 2014) – 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 Cervical Scan.
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 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.
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Contacts
Bill
Wells, Guided Therapeutics – 770-242-8723
Investors:
Alison Ziegler, Cameron Associates – 212-554-5469
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