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) July 8, 2014; (July 2, 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))

 

  

1

   

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.

Number	Exhibit
99.1	Press Release dated July 2, 2014

 

  

2

 

 

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:  July 8, 2014

 

  

3

Exhibit 99.1

  

	5835 Peachtree Corners East, Suite D
	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