0001121781-11-000109.txt : 20110427 0001121781-11-000109.hdr.sgml : 20110427 20110427161123 ACCESSION NUMBER: 0001121781-11-000109 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20110427 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110427 DATE AS OF CHANGE: 20110427 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GUIDED THERAPEUTICS INC CENTRAL INDEX KEY: 0000924515 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 582029543 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-22179 FILM NUMBER: 11783783 BUSINESS ADDRESS: STREET 1: 4955 AVALON RIDGE PKWY STREET 2: SUITE 300 CITY: NORCROSS STATE: GA ZIP: 30071 BUSINESS PHONE: 7702428723 MAIL ADDRESS: STREET 1: 4955 AVALON RIDGE PKWY STREET 2: SUITE 300 CITY: NORCROSS STATE: GA ZIP: 30071 FORMER COMPANY: FORMER CONFORMED NAME: SPECTRX INC DATE OF NAME CHANGE: 19970226 8-K 1 gthp8k42711.htm GUIDED THERAPEUTICS, INC. gthp8k42711.htm
 
 


 
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) April 27, 2011;  April 26, 2011
 
GUIDED THERAPEUTICS, INC.
 (Exact Name of Registrant as Specified in Its Charter)
 
         
Delaware
(State or Other Jurisdiction of Incorporation)
 
0-22179
(Commission File Number)
 
58-2029543
(IRS Employer Identification No.)

   
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 :
 
 
 
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
     
 
 
 
 
 
 

 
 
 
Section 7.01  (Regulation FD Disclosure)
 
On April 26, 2010, the registrant publicly issued a press release announcing the results of a meeting with the U.S. Food and Drug Administration regarding the registrant’s pending pre-market approval application for its non-invasive cervical disease detection device, 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 April 27, 2010, the registrant publicly issued a press release announcing it intends to unveil its cervical disease detection technology new design and branding at ACOG and EUROGIN Meetings, 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

The following exhibit is furnished with this report:
 
 Exhibit No    Description
99.1  Press Release Dated April 26, 2011
 99.2   Press Release Dated April 27, 2011
 

 
 
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.
 
 
     GUIDED THERAPEUTICS, INC  
       
   By:  /s/ MARK L. FAUPEL  
                                                                                                                                                                                                                  Mark L. Faupel, Ph.D.  
     CEO & President  
 Date:  April 27, 2011      
 
 
 
 
 
 
 
 
 
2

 
 
EX-99.1 2 ex99one.htm PRESS RELEASE DATED APRIL 26, 2011 ex99one.htm
 
 


Exhibit 99.1
 
 
 
 
5835 Peachtree Corners East, D - Norcross, GA  30092
Telephone (770) 242-8723  Fax (770) 242-8639    
 
 
Contacts
Media: Deanne Eagle, Cameron Associates – 917-837-5866
Bill Wells, Guided Therapeutics – 770-242-8723
Investors: Alison Ziegler, Cameron Associates – 212-554-5469

 
Guided Therapeutics Holds Productive Meeting with FDA on PMA Review of
 Cervical Cancer Test
 
NORCROSS, GA (April 26, 2011) – Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP), announced that it held a productive meeting with U.S. Food and Drug Administration (FDA) officials to review the company’s premarket approval application (PMA) for its non-invasive test for the early detection of cervical pre-cancer.
 
During the meeting with FDA reviewers, which was requested by Guided Therapeutics, company representatives outlined proposed responses to recent FDA questions regarding the PMA application and also held discussions regarding proposed claims for use for the technology.
 
“We are pleased with the content and outcome of the meeting with our FDA reviewers,” said Mark L. Faupel, President and CEO of Guided Therapeutics, Inc.  “There was constructive dialog regarding the questions and our responses.  We believe that we came away with clear guidance and a plan for achieving a panel meeting in the future.  We plan to take what we learned from the meeting and finalize our responses to the questions in the next two to three weeks.”
 
As a result of the meeting, the FDA also offered to hold additional working group sessions with the company in anticipation and preparation of panel review.
 
The PMA application for the technology was accepted for filing by the FDA as of September 23, 2010.  As previously announced, the technology will be the subject of a presentation at The American College of Obstetricians and Gynecologists (ACOG) 59th Annual Clinical Meeting to be held April 30 to May 4, 2011 in Washington, DC and is also the subject of a presentation at the EUROGIN scientific meeting in Lisbon later in May.
 
The technology, which consists of a base unit and single-patient-use calibration disposable, scans the cervix with light to identify cancer and pre-cancer painlessly and non-invasively.  Guided Therapeutics’ patented biophotonic technology is able to distinguish between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the Guided Therapeutics test does not require laboratory analysis or a tissue sample, is designed to provide results immediately and eliminate costly unnecessary testing.
 
About Guided Therapeutics
 
Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP) is developing a rapid and painless testing platform for the early detection of disease based on its patented biophotonic technology that utilizes light to detect disease at the cellular level.  The company’s first planned product is 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 has also entered into a partnership with Konica Minolta Opto to develop a non-invasive test for Barrett’s Esophagus using the technology platform. For more information, visit: www.guidedinc.com.
 
 
 
 
 

 
 
Guided Therapeutics – FDA update
April 26, 2011
Page 2
 
The Guided Therapeutics Non-invasive Cervical Cancer Detection Device is an investigational device and is limited by federal law to investigational use.
 
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995. 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: 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, 2010.
 
 
# # #
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
EX-99.2 3 ex99two.htm PRESS RELEASE DATED APRIL 27, 2011 ex99two.htm
 
 


Exhibit 99.2
 
 
 
 
5835 Peachtree Corners East, D - Norcross, GA  30092
Telephone (770) 242-8723  Fax (770) 242-8639    
 
 
Contacts
Media: Deanne Eagle, Cameron Associates – 917-837-5866
Bill Wells, Guided Therapeutics – 770-242-8723
Investors: Alison Ziegler, Cameron Associates – 212-554-5469

 
Guided Therapeutics to Unveil Cervical Disease Detection Technology New
 Design and Branding at ACOG and EUROGIN Meetings
 
Principal investigators to present results of FDA clinical trials
 
NORCROSS, GA (April 27, 2011) – Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP), announced that it will present the new design and branding of its non-invasive and painless test for the early detection of cervical precancer at two upcoming international gynecology conferences.  Additionally, attendees will be briefed on results of the pivotal clinical trial of the technology by two principal investigators.
 
“We are excited about the new design and branding for the cervical detection technology and believe it will be well received,” said Mark L. Faupel, Ph.D., CEO and President of Guided Therapeutics, Inc.  “We are also pleased to have two of our principal investigators scheduled to present findings of our clinical trial to such prestigious medical conferences.”
 
Dr. Leo B. Twiggs, professor in the Department of Obstetrics and Gynecology at the University of Miami, Miller School of Medicine, is scheduled to present Study Results of a New Test for Cervical Dysplasia: Potential Impact on Patient Management, on Monday, May 2nd from 2 p.m. to 4 p.m. at The American College of Obstetricians and Gynecologists (ACOG) 59th Annual Clinical Meeting to be held April 30 - May 4, 2011 in Washington, DC.  The company will display the design and brand at booth 621 beginning Monday, May 2nd.
 
Dr. Lisa Flowers, of Emory University and Grady Hospital of Atlanta, is scheduled to present Introducing a New Diagnostic Modality into the Standard of Care at the EUROGIN scientific meeting in Lisbon, Portugal on Tuesday, May 10th from 9:30 a.m. to 11:00 a.m. The company will display the design and brand at booth 4.13 beginning Sunday, May 8th.
 
The technology, which consists of a base unit and single-patient-use calibration disposable, scans the cervix with light to identify cancer and pre-cancer painlessly and non-invasively.  Guided Therapeutics’ patented biophotonic technology is able to distinguish between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the Guided Therapeutics test does not require laboratory analysis or a tissue sample, is designed to provide results immediately and eliminate costly unnecessary testing.
 
The technology is currently under U.S. Food and Drug Administration premarket approval review.  In January 2011, Guided Therapeutics was awarded ISO 13485 certification for its quality system, a precursor for the CE mark required for sales in the European Union.
 
 

 
 

 
 
 
Guided Therapeutics – ACOG/EUROGIN
April 27, 2011
Page 2
 
About ACOG
 
Founded in 1951 in Chicago, Illinois, ACOG has over 52,000 members and is the nation's leading group of professionals providing health care for women.  Now based in Washington, DC, it is a private, voluntary, nonprofit membership organization.  For more information, visit www.acog.org.
 
About EUROGIN –
 
EUROGIN (EUropean Research Organisation on Genital Infection and Neoplasia) brings together clinicians and scientists whose work is related to genital infections and neoplasia.  The aims of the organization are to promote and develop, at a European level, research, training, screening, prevention and information concerning genital infections, precancers and cancers in women.  Developed as a result of a common European resolution, EUROGIN brings together representatives of all the specialist areas concerned: gynaecologists, dermatologists, pathologists, biologists, oncologists and basic scientists. For more information, visit www.eurogin.com/2011/.
 
About Guided Therapeutics
 
Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP) is developing a rapid and painless testing platform for the early detection of disease based on its patented biophotonic technology that utilizes light to detect disease at the cellular level.  The company’s first planned product is 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 has also entered into a partnership with Konica Minolta Opto to develop a non-invasive test for Barrett’s Esophagus using the technology platform. For more information, visit: www.guidedinc.com.
 
The Guided Therapeutics Non-invasive Cervical Cancer Detection Device is an investigational device and is limited by federal law to investigational use.
 
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995. 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: 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, 2010.
 
 
# # #
 
 
 
 
 
 
 
 

 
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