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 20, 2015; (May 19, 2015)

GUIDED THERAPEUTICS, INC.

 (Exact Name of Registrant as Specified in Its Charter)

Delaware	0-22179	58-2029543
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(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:

[ ]	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 19, 2015, the registrant publicly issued a press release announcing that the Company received notification from the U.S. Food and Drug Administration (FDA) that the pre-market approval (PMA) application for the LuViva^® Advanced Cervical Scan was not approvable in its current form, 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 20, 2015, the registrant conducted a conference call discussing the notification from the FDA regarding the PMA application, and other matters concerning the operation of the company, as more fully described in the prepared transcript of the call, 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 19, 2015
99.2	Transcript of Conference Call held on May 20, 2015

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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 20, 2015

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EX-99.1

Exhibit 99.1

 

5835 Peachtree Corners East, Suite D

Norcross, GA 30092

FOR IMMEDIATE RELEASE

FDA Completes Review of Guided Therapeutics’ LuViva^® Advanced Cervical Scan

PMA Application

Agency Provides Guidance on Paths to Approval That Include Submission of Additional Patient Data

NORCROSS, GA (May 19, 2015) – Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced that it has received notification from the U.S. Food and Drug Administration (FDA) regarding the pre-market approval (PMA) application for the LuViva^® Advanced Cervical Scan. In its most recent communication, FDA advised the Company that its PMA amendment, filed in July 2014, was not approvable in its current form. While the agency advised the Company that more patient data would likely be necessary to amend the current application, the agency also stated its willingness to consider alternative approaches to move the product to approvable form.

FDA and the Company intend to meet to discuss the plan for submission of an updated amendment and ultimately reach agreement on steps forward for a path to approval to resolve any remaining data analysis issues. At this meeting, the Company intends to present additional U.S. and international data that the Company believes will further support the clinical benefits of LuViva.

“We believed our PMA amendment addressed the remaining questions the agency had about our original application,” said Gene Cartwright, Chief Executive Officer of Guided Therapeutics. “At the current time, however, we believe the best and fastest way to secure approval may be to collect data on additional subjects and then file an amendment to further demonstrate LuViva’s safety and effectiveness as a triage device after an abnormal HPV test or Pap test. While we are disappointed the data analysis issue was not fully resolved, we are encouraged that no other remaining or new issues were raised in the FDA letter.

“We are confident we will eventually receive approval to market LuViva in the U.S. and will provide more detail once we meet with FDA to determine what our pathway to approval will be.  In the meantime, we continue to add to the growing number of doctors successfully using LuViva in the much larger international market and have significant momentum building, particularly where our product is being considered for screening.  In 2015 we expect our sales to grow significantly, with orders from Turkey and Kenya driving our near term results, said Mr. Cartwright.”

The Company currently has regulatory approval to sell LuViva in Europe with the Edition 3 CE mark, and has marketing approvals from COFEPRIS in Mexico, Health Canada and Singapore Health Sciences Authority, among others. Additionally, expansion efforts are ongoing in the Middle East, Asia and Latin America.

Conference Call

Guided Therapeutics will hold a conference call at 9:00 a.m. EDT on Wednesday, May 20, 2015, to discuss the FDA response. Interested parties are invited to listen to the call live over the Internet at www.guidedinc.com/investors/. The live call will also be available by dialing (888) 587-0615 or for international callers (719) 785-1765 and referencing Conference ID 8871318. A replay of the teleconference will be available on www.guidedinc.com/investors/. A replay will also be available until May 27, 2015 by dialing (877) 870-5176 or for international callers (858) 384-5517, and using pin number 8871318.

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 may result in eliminating costly, painful and unnecessary additional testing. LuViva is intended 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. It has also been used in clinical studies in Turkey and Nigeria as a means to screen women for cervical cancer where the availability of infrastructure necessary for Pap and HPV testing is restricted. 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. 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 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, 2014, and subsequent quarterly reports.

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Contacts

Bill Wells, Guided Therapeutics – 770-242-8723

Investors: Alison Ziegler, Cameron Associates – 212-554-5469

EX-99.2

Exhibit 99.2

May 2015 FDA Update Conference Call Script

May 20 - 9:00 a.m.

Opening – Alison Ziegler

Good morning and welcome to the Guided Therapeutics conference call and webcast to discuss the recent response by FDA of the review of the Amended PMA for the LuViva® Advanced Cervical Scan Application.

On today's call we have: Guided Therapeutics CEO and President Gene Cartwright.

During this call the Company will be making forward-looking statements. These statements can obviously differ from actual results, so to rely on them is subject to risk. Factors that could cause forward-looking statements in this call to differ materially from actual results are discussed in the company's Form 10-K for the year ended December 31, 2014, and subsequent filings with the Securities and Exchange Commission

So at this time I will turn the conference call over to Gene.

Gene

Thank you, Alison and welcome everyone.

Today we are here to discuss the latest communication from the U.S. Food and Drug Administration regarding our amended premarket approval application for the LuViva Advanced Cervical Scan.

As you saw in last night’s press release, the agency communicated that our application amendment, which we submitted back in July 2014, is in not approvable form. This means that the agency has questions that need to be resolved before granting LuViva approval status.

The most likely path forward to approval, as indicated by the agency, is to collect additional patient data in a clinical trial setting. We knew that collecting additional patient data may be necessary either before or after approval. The agency decided that we should collect that data before granting approval.

While we are disappointed in the agency’s decision, we are prepared to begin collecting this additional data as soon as the clinical trial protocols can be worked out. We already have one clinical site up and running in the US collecting data for our international screening claim. We believe that this site can be converted to collect data for this new study, which we hope will be small and tightly focused.

The few remaining differences are in our opinion, technical in nature and we will continue a dialogue with the agency on alternative solutions, but we will also move forward by collecting more patient data like we have been collecting around the world and presenting to medical society meetings.

We plan to meet with FDA sometime, in what we hope would be the next three months, to discuss steps forward for a path to approval and develop the plan for submission of an updated amendment. I will caution you that getting a meeting with the agency can take time, and that communication back and forth is slow.

I would like to note that no other remaining or new issues were raised in the FDA letter. We are confident we will eventually receive approval to market LuViva in the U.S. and will provide more detail once we meet with FDA to determine what our pathway to approval will be.

While we’re frustrated by the news, we also know that even if we had gotten approval, we wouldn’t have entered the US market for a minimum 9-12 months. As a result and because the international opportunity is larger - as much as 5 times larger than the US market – and with more high margin disposables due to the desire to use LuViva for screening, we’ve always been focused on our international sales. And as you know, we’ve never provided any US sales estimate in any of our sales projections.

I also want to provide a quick update on our financing plans. We are working with our investment banker and we expect to be able to update you on our capital raising efforts shortly. Our plans have not changed based on this recent FDA news and we are confident that we will obtain funding.

In the meantime, we continue to add to the growing number of doctors successfully using LuViva internationally and will focus our energies on growing sales where the clinical need for our product is greatest. We have significant momentum building, particularly where our product is being considered and used for screening.  In 2015, we expect our sales to grow significantly, with orders from Turkey and Kenya driving our near term results.

Thank you for your time. We will keep you updated on our progress as we prepare to respond to the FDA and continue to launch LuViva in the rest of the world. I’ll now turn the call over to the operator for your questions.

After taking questions

Thank you operator, thanks to everyone on the call. We look forward to speaking with you again soon.