Current Report Filing (8-k)

 

 

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)

 

Delaware	0-22179	58-2029543
(State or Other Jurisdiction of	(Commission File Number)	(IRS Employer Identification No.)
Incorporation)

 

 

5835 Peachtree Corners East, Suite D Norcross, Georgia (Address of Principal Executive Offices)	30092 (Zip Code)

 

Registrant's Telephone Number, Including Area Code:     [phone]

 

 

 

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:

  

 

	[ ]	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
	[ ]	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
	[ ]	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
	[ ]	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.

Number	Exhibit
99.1	Press Release dated May 27, 2014
99.2	Press Release dated May 27, 2014

 

  

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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/ Gene Cartwright
		Gene Cartwright
		Chief Executive Officer
Date: May 27, 2014

 

  

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Exhibit 99.1

  

	5835 Peachtree Corners East, Suite D
	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

 

 

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 Exhibit 99.2

	5835 Peachtree Corners East, Suite D
	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 3^rd 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.

 

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