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)
May 27, 2014; (May 27, 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
May 27, 2014, the registrant publicly issued a press release announcing that the registrant’s LuViva® Advanced
Cervical Scan detected 100% of precancers in a blinded clinical study, the results of
which were presented at an international cervical pathology and colposcopy conference in London, 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.
On
May 27, 2014, the registrant publicly issued a press release announcing that the registrant’s representative
would present at the annual Marcum MicroCap Conference on Thursday, May 29, as more
fully described in the press release, a copy of which is furnished as Exhibit 99.2 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 May 27, 2014 |
99.2 |
Press Release dated May 27, 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: May 27, 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’ LuViva®
Advanced Cervical Scan Detected 100% of
Precancers in New Blinded Clinical Study Presented at an International Cervical
Pathology and Colposcopy Conference
LuViva
would eliminate nearly half of unnecessary biopsies;
Confirmed
earlier studies by detecting more disease than HPV testing
LONDON
(May 27, 2014) –
The LuViva® Advanced Cervical Scan identified 100% of all cervical disease cases in a blinded clinical study presented
at the International Federation for Cervical
Pathology and Colposcopy
(IFCPC) meeting in London on May 27, 2014. LuViva also correctly identified 44% of women who had a previous abnormal Pap
test and who were determined to be false positives as part of the study. LuViva, a
non-invasive device used
to detect cervical
disease instantly at
the point of
care, is a product of Guided Therapeutics,
Inc. (OTCQB: GTHP) (OTCBB: GTHP).
“This
study reinforces not only the superior performance of LuViva, but also highlights the clinical need for point-of-care results
to eliminate the high number of unnecessary, painful and costly testing of conventional tissue sample methods such as biopsy,”
said Gene Cartwright, Chief Executive Officer of Guided Therapeutics. “As we introduce LuViva into clinical settings around
the world, not only are we positioned to address the tremendous unmet need in developed countries to reduce the high number of
false positive results created by conventional testing but we see an even greater opportunity in the developing world to uncover
disease where the infrastructure to support conventional, lab-based testing is not available.”
The
study, titled “LuViva Cervical Scan as a Triage Test to Reduce Unnecessary Colposcopy and Biopsy,” was conducted on
55 women who had positive Pap tests and were referred to follow up visits with their gynecologist for a colposcopy exam and biopsy.
Each subject served as their own control with biopsy being the gold standard for true positive diagnosis.
According
to the conclusions of the study: “The high sensitivity, specificity and resulting high negative predictive value of LuViva
imply that nearly half of the women currently undergoing colposcopy and biopsy could safely avoid those procedures, thereby improving
clinic efficiency and resulting in significant savings to health care systems.”
In
the same study, 76% of women tested positive for human papillomavirus (HPV). The HPV testing not only increased the number of
false positives, but missed one of the 12 cases of disease correctly identified by LuViva and confirmed by biopsy.
The
study was conducted by Dr. James Bentley, Secretary General of the IFCPC and Professor and Division Head of Gynecology Oncology
at Dalhousie University School of Medicine in
Halifax,
Nova Scotia and Dr. Richard Zane of the Atlanta Women’s Research Institute in Atlanta, Georgia. The study was partially
funded by the National Cancer Institute.
About
the IFCPC
The International Federation for Cervical Pathology and Colposcopy represents 37 National Pathology and Colposcopy
Societies from around the world. The IFCPC’s 15th World Congress will bring together leading scientists, public health experts
and policy-makers to translate recent momentous scientific advances into action that will address means to end the epidemic, within
the current context of significant global economic challenges. For more information visit: http://ifcpc2014.com.
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.
Contacts
Bill
Wells, Guided Therapeutics
– 770-242-8723
Investors:
Alison Ziegler, Cameron
Associates – 212-554-5469
###END###
Exhibit
99.2
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5835
Peachtree Corners East, Suite D |
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Norcross, GA
30092 |
Contacts
Bill
Wells, Guided Therapeutics – 770-242-8723
Investors:
Alison Ziegler, Cameron Associates – 212-554-5469
Guided
Therapeutics to Present at Annual Marcum MicroCap
Conference
on Thursday, May 29
Norcross,
GA (May 27, 2014) -- Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) developer of the LuViva® Advanced
Cervical Scan, a non-invasive device used to detect cervical disease that leads to cancer, today announced that it will be a featured
presenter at the 3rd Annual Marcum MicroCap Conference on Thursday, May 29, 2014 at the Grand Hyatt Hotel in New York
City.
The
Company’s presentation by Chief Executive Officer Gene Cartwright is scheduled to begin at 3:30 p.m. EDT and will be available
via a live webcast. To access the webcast and a copy of the investor presentation, go to the Investor page of the Company's web
site http://www.guidedinc.com/Investors.htm. The webcast will also be available at http://wsw.com/webcast/marcum2/gthp. A replay
will be available for 90 days.
The
annual Marcum MicroCap Conference is a signature showcase for superior quality, under-followed public companies with less than
$500 million in market capitalization. For more information or to register, please visit the conference website at http://www.marcumllp.com/microcap
or download the free official conference app for the iPhone, iPad, or for Android mobile devices in Apple’s App Store and
the Google Play Market.
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 is 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 sufficiency of capital
raised in our prior financings and our ability to realize their expected benefits, the uncertainty of future capital to develop
products or continue as a going concern, the uncertainty of regulatory approval of products, and the 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.
###END###
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