Silicon Investor - Guided Therapeutics - GTHP

[caly] Guided Therapeutics Notified of CE Mark Approval for LuViva® Advanced Cervical S...

caly — 7/18/2012 12:07:49 PM

Guided Therapeutics Notified of CE Mark Approval for LuViva® Advanced Cervical Scan

NORCROSS, Ga.--(BUSINESS WIRE)--

Guided Therapeutics, Inc. ( GTHP) ( GTHP) today announced that it has received notification that CE Mark approval has been granted for LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease that leads to cancer, instantly and at the point of care.

The CE Mark is required to sell products in the 27 nations that comprise the European Union (EU). There are about 146 million women who are targeted by existing or planned cervical cancer screening programs in EU member states, according to the European Cancer Observatory.

“The notification of CE Mark for LuViva is a significant milestone for the company and allows us to begin our European launch later this year, as planned,” said Mark L. Faupel, Ph.D., president and CEO of Guided Therapeutics. “We believe that together with our distributors, we have a tremendous opportunity to improve the detection of cervical disease, reduce false positives and unnecessary biopsies, and provide significant savings to healthcare systems throughout Europe.”

“Notification of the CE Mark and previously announced Health Canada approval for LuViva further validates the product and our ability to manufacture to the highest standards. We expect the CE Mark award will generate more demand for the product and open opportunities in markets outside the EU as well. In addition to the more than 20 countries already covered by distribution agreements, we plan to expand our network to additional countries in Europe, Latin America and Asia and having the CE Mark should accelerate those efforts,” Dr. Faupel added.

Today's CE Mark notification is the first of two expected for LuViva. A second CE Mark application is expected to be filed later this year to comply with updated European medical device standards and to include design improvements. The company also must continue to pass annual ISO audits of its quality system in order to maintain the CE Mark on its products. The company has passed two consecutive ISO audits, the last being in January of 2012.

In addition to the CE Mark, LuViva has marketing approval from Health Canada and remains under U.S. Food and Drug Administration premarket approval review. Guided Therapeutics was awarded ISO 13485 certification in January, 2011.

The study used to support LuViva’s CE Mark application was the multi-center U.S. pivotal trial, in which 1,607 women at risk for developing cervical disease were evaluated. In this patient population, LuViva was able to detect cervical cancer up to two years earlier than the Pap test, human papillomavirus (HPV) test, colposcopy and biopsy. LuViva detected 86.3 percent of the cervical disease cases that had been missed by Pap, HPV tests and biopsy. LuViva would have reduced the number of unnecessary biopsies by about 40 percent. LuViva is initially intended as a follow-up test after a positive Pap result.

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. ( GTHP) ( 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 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 has also entered into a partnership with Konica Minolta to develop a non-invasive test for Barrett’s Esophagus 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.

[caly] At least things are moving ahead in Canada... Published: Tuesday, Jan. 31, 2012...

caly — 1/31/2012 11:44:03 AM

At least things are moving ahead in Canada...

Published: Tuesday, Jan. 31, 2012
Updated: Tuesday, Jan. 31, 2012
Guided Therapeutics Selects CAN-med Healthcare to Distribute LuViva® Advanced Cervical Scan in Canada

Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced that it has signed a definitive agreement granting CAN-med Healthcare exclusive distribution rights for LuViva® Advanced Cervical Scan in Canada.

The agreement is for three years and initial shipments are currently anticipated in the second quarter of 2012. A formal launch is expected to begin shortly thereafter. LuViva received Health Canada marketing approval in December 2011 under its former name, LightTouch.

“CAN-med is a leading and greatly respected healthcare company and we are pleased to have them as our partner in Canada,” said Mark L. Faupel, Ph.D., CEO and president of Guided Therapeutics, Inc. “CAN-med’s nation-wide reputation and commitment to women’s health, from mammography to gynecological imaging products, makes the company ideally suited to introduce LuViva to the Canadian market and grow market share.”

“Based on LuViva’s documented clinical evidence and our 35 years of experience delivering innovations to the Canadian healthcare market, we believe that LuViva will be well received, with an opportunity to positively impact the lives of women at risk for developing cervical cancer,” said Jim Ritcey, Director, Sales and Marketing, Medical/Surgical for CAN-med Healthcare. “Additionally, we believe that LuViva will bring a new level of efficiency and cost effectiveness to the healthcare system.”

Stephen McDonald, CAN-med’s Vice President & General Manager adds “Guided Therapeutics and the LuViva product are a great match for us in bringing new products to the Canadian market. They fit the criteria we’re looking for by being clinically innovative with new technology, being willing to develop an exclusive working relationship, and delivering better clinical and patient outcomes.”

Each year in Canada, about 5.7 million women undergo Pap test screening for cervical cancer, with as many as 400,000 receiving an abnormal Pap result. These women are then scheduled for a follow-up exam, called a colposcopy, which typically includes a biopsy. The wait times for colposcopy examinations in Canada are typically between two to six months. LuViva is designed to reduce wait times and provide results immediately at the point of care.

About CAN-med Healthcare

CAN-med Healthcare, a division of IMP Group Limited, is a national, integrated healthcare distribution and service company with a portfolio of businesses providing products and technical service spanning four distinct segments of the healthcare market: Medical/Surgical; Diagnostic Imaging; Rehab/Mobility/Home Medical Equipment; and Dental products.

IMP Group Limited is focused on global sustainable growth with 3,700 experienced people delivering service, quality and value to customers across diverse sectors, including aerospace, aviation, airline, healthcare, information technology, hospitality and property development.

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 & 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 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 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.

Read more here: bradenton.com

[caly] Guided Therapeutics Provides Update on PMA Application for LuViva® Advanced Cerv...

caly — 1/20/2012 6:08:16 PM

Guided Therapeutics Provides Update on PMA Application for LuViva® Advanced Cervical Scan and Timing for Filing of CE MarkCompany to Host Conference Call with Investors on January 23 at 10 A.M. EST

NORCROSS, Ga.--(BUSINESS WIRE)-- Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP) today announced that the company plans to seek an independent panel review of its Pre-market Approval (PMA) application for the LuViva® Advanced Cervical Scan from the U.S. Food and Drug Administration (FDA) after receiving a not-approvable letter from the agency. Meanwhile, the company plans to work with FDA to address the outstanding issues so that they can be successfully resolved.

The Company also announced that it plans to move forward with international sales of Luviva and imminently file for CE mark approval.

"We are disappointed that the FDA has issued a not-approvable letter after previously telling the company that a panel review of LuViva would not be necessary since the agency understood LuViva’s technology, it understood the clinical application and had also reviewed similar devices in the past,” said Mark L. Faupel, Ph.D., president and CEO of Guided Therapeutics. "Similar to the two most recent spectroscopy cancer diagnostic products approved by FDA after first receiving not-approvable letters, we plan on seeking a panel review in order to be granted approval.”

“The company plans to focus more on European and Asian regulatory approvals, while continuing to aggressively pursue approval in the U.S.,” said Dr. Faupel. “With the imminent filing of the CE mark, sales should begin in Europe in the second half of 2012. Based on initial agreements with distributors and the national healthcare structure of medicine in many overseas countries, we believe LuViva would likely be utilized in many institutions more focused on Pap test follow up. Therefore, we would expect that a greater percentage of international sales will come from high margin disposables. As a result of this sales mix, and the lower capital requirements for a launch outside the U.S., our path to breakeven is expected to come as early as 2013, sooner than if we had also initiated marketing in the U.S. this year.”

“In the meantime, our clinical trial data system, two of our clinical trial sites and one of our major suppliers has already undergone successful FDA audits and we will continue working with the agency on a path to approval,” said Dr. Faupel.

LuViva was awarded marketing approval for Canada in December, 2011 by Health Canada. Also in December, LuViva was selected by the National Cancer Institute as one of the agency’s successful investments for developing innovative products to fight cancer.

Conference Call Information

Guided Therapeutics will host a conference call at 10 a.m. EST on Monday, January 23, 2012, to discuss the FDA’s response. Interested parties are invited to listen to the call live over the Internet at us.lrd.yahoo.com**http%3A//cts.businesswire.com/ct/CT%3Fid=smartlink%26url=http%253A%252F%252Fwww.guidedinc.com%252Finvestors.htm%26esheet=50141003%26lan=en-US%26anchor=http%253A%252F%252Fwww.guidedinc.com%252Finvestors.htm%26index=1%26md5=b7991bc4beb0e6149edc46e1503fa990 or us.lrd.yahoo.com**http%3A//cts.businesswire.com/ct/CT%3Fid=smartlink%26url=http%253A%252F%252Fwww.viavid.net%26esheet=50141003%26lan=en-US%26anchor=http%253A%252F%252Fwww.viavid.net%26index=2%26md5=9137407cbf07296d1dacf4765d8a24d6. The live call is also available by dialing (888) 569-5033 or for international callers (719) 457-2647.

A replay of the teleconference will be available on us.lrd.yahoo.com**http%3A//cts.businesswire.com/ct/CT%3Fid=smartlink%26url=http%253A%252F%252Fwww.guidedinc.com%252Finvestors.htm%26esheet=50141003%26lan=en-US%26anchor=http%253A%252F%252Fwww.guidedinc.com%252Finvestors.htm%26index=3%26md5=e1a9a15c6f0104034bf4f452fc535b9f. A replay will also be available until January 30, 2012 by dialing (877) 870-5176 or (858) 384-5517, and using pin number 4235585.

[caly] Just noticed that it took 6 days for the last notice to be posted to the website...

caly — 1/20/2012 3:55:24 PM

Just noticed that it took 6 days for the last notice to be posted to the website after the date of approval.

[caly] Medical Devices News page at the FDA. Nothing yet. fda.gov

caly — 1/20/2012 1:28:44 PM

[caly] Today's the day they were supposed to hear from FDA...according to the FDA.

caly — 1/20/2012 10:28:22 AM

[caly] Weak hands being shaken or bad news leaking? Place your bets!

caly — 1/11/2012 1:19:59 PM

[caly] Health Canada Approves Guided Therapeutics' LuViva(TM) Advanced Cervical Scan fo...

caly — 12/14/2011 2:46:22 PM

Health Canada Approves Guided Therapeutics' LuViva(TM) Advanced Cervical Scan for Detecting Precancer of the Cervix

NORCROSS, Ga., Dec 14, 2011 (BUSINESS WIRE) -- Guided Therapeutics, Inc. (otcbb & otcqb:GTHP) today announced that Health Canada has granted marketing approval for the LuViva(TM) Advanced Cervical Scan.

The approval by Health Canada provides LuViva access to the United States' largest trading partner and to other markets that recognize Canadian device approval.

"Receiving Health Canada marketing approval for LuViva is a significant milestone for the product and the company," said Mark L. Faupel, Ph.D., CEO and president of Guided Therapeutics, Inc. "We are in discussions with potential distributors in Canada and expect this approval to advance the process. Additionally, the Health Canada approval helps to jumpstart and support the regulatory process in some Latin America and Southeast Asian countries."

Each year, about 5.7 million women in Canada undergo Pap test screening for cervical cancer, with as many as 400,000 receiving an abnormal Pap result. These women are then scheduled for a follow-up exam, called a colposcopy, which typically includes a biopsy. The wait times for colposcopy examinations in Canada are two to six months. LuViva is designed to reduce wait times and provide results immediately at the point of care.

"We believe that LuViva has the potential to bring a new level of efficiency to women's healthcare in Canada and improve the standard of care by providing immediate results with a painless, one-minute test," said Dr. Faupel.

LuViva 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 changes at the cellular level. Unlike Pap or human papillomavirus (HPV) tests, LuViva does not require laboratory analysis or a tissue sample.

The Health Canada application was filed under the former name, "LightTouch" and will be amended to reflect the name change to LuViva.

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 the LuViva(TM) 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 has also entered into a partnership with Konica Minolta Opto to develop a non-invasive test for Barrett's esophagus using the same technology platform. For more information, visit: www.guidedinc.com .

[caly] Be it a coincidence or not, January, the assumed month of FDA approval, is Natio...

caly — 12/9/2011 12:10:14 PM

Be it a coincidence or not, January, the assumed month of FDA approval, is National Cervical Health Awareness Month.

[caly] National Cancer Institute Designates Guided Therapeutics’ LuViva™ Advanced Cervi...

caly — 12/9/2011 12:07:05 PM

National Cancer Institute Designates Guided Therapeutics’ LuViva™ Advanced Cervical Scan an Investment Success Story Press Release: Guided Therapeutics, Inc. – Thu, Dec 8, 2011 9:00 AM EST

NORCROSS, Ga.--(BUSINESS WIRE)-- The National Cancer Institute (NCI) has designated the LuViva™ Advanced Cervical Scan by Guided Therapeutics, Inc. (OTCBB: GTHP.OB - News) as one of the agency’s successful investments for developing innovative products to fight cancer.

NCI has awarded Guided Therapeutics more than $6 million in six consecutive grants since 2001 to develop LuViva, a new technology designed to scan the cervix with light to detect precancer and provide a result immediately. The full story from NCI can be accessed on line at:http://us.lrd.yahoo.com/_ylt=AuaHyJKMZGZa5t.4KlRJLb4GuodG;_ylu=X3oDMTFqaGFmbHBnBG1pdANBcnRpY2xlIEJvZHkEcG9zAzUEc2VjA01lZGlhQXJ0aWNsZUJvZHlBc3NlbWJseQ--;_ylg=X3oDMTJ0NzgzamE1BGludGwDdXMEbGFuZwNlbi11cwRwc3RhaWQDZjQ1ZDA4ZTgtMGUzYy0zOGE1LWFlMzUtODg0MzdkY2Y3ZTMyBHBzdGNhdANuZXdzBHB0A3N0b3J5cGFnZQR0ZXN0Aw--;_ylv=0/SIG=1b40vkaqq/EXP=1324659974/**http%3A//cts.businesswire.com/ct/CT%3Fid=smartlink%26url=http%253A%252F%252Fsbir.cancer.gov%252Fsuccess%252Fstories%252Fguided_therapeutics%252Findex.asp%26esheet=50099811%26lan=en-US%26anchor=http%253A%252F%252Fsbir.cancer.gov%252Fsuccess%252Fstories%252Fguided_therapeutics%252Findex.asp%26index=3%26md5=b2136c8a4775bf251bb8b9808430e23b.

“We are honored that LuViva has been acknowledged as a successful investment by the world’s leading cancer research organization,” said Mark L. Faupel, Ph.D., CEO and president of Guided Therapeutics, Inc. “This recognition underscores LuViva’s unique approach for improving the standard of care in cervical disease detection. The NCI is a valuable partner in the development of LuViva, and the collaborative support of the agency makes innovation like ours possible.”

LuViva is currently under U.S. Food and Drug Administration (FDA) premarket application review. The FDA has informed Guided Therapeutics that the agency expects to rule on the application by January 20, 2012.

LuViva 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, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide immediate results at the point of care, eliminating costly and painful testing.

NCI Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are an important source of early-stage technology financing for small businesses. The NCI SBIR & STTR Programs foster research and development for anticancer agents, biomarkers, informatics, medical devices, nanotechnology, proteomics, pharmacodynamics, and many other biotechnologies, as well as programs designed to prevent, diagnose, and treat cancer.

The NCI is part of the National Institutes of Health, which is one of 11 agencies that make up the U.S. Department of Health and Human Services.

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 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 has also entered into a partnership with Konica Minolta Opto to develop a non-invasive test for Barrett’s esophagus using the same technology platform. For more information, visit: www.guidedinc.com.

[caly] Form 8-K for GUIDED THERAPEUTICS INC 28-Nov-2011 Entry into a Material Definit...

caly — 11/28/2011 12:29:19 PM

Form 8-K for GUIDED THERAPEUTICS INC

28-Nov-2011

Entry into a Material Definitive Agreement, Unregistered Sale of Equity Securities

Item 1.01. Entry into a Material Definitive Agreement.Pursuant to subscription agreements effective November 21, 2011, on that date Guided Therapeutics, Inc. (the "Company") completed a private sale to George Landegger and his affiliate, The Whittemore Collection, Ltd., of (i) an aggregate of 2,055,436 shares of the Company's common stock and (ii) warrants to purchase up to an aggregate of 285,186 shares of the Company's common stock, for an aggregate offering price of approximately $1.73 million.

For each share of common stock purchased, subscribers received warrants exercisable for the purchase of 0.1387 of one share of common stock (in the aggregate, 285,186 shares) at an exercise price of $1.05 per share. The warrants have a five-year term.

Pursuant to the subscription agreements effective November 21, 2011, George Landegger and his affiliate, The Whittemore Collection, Ltd., agreed to exercise an aggregate of 370,371 warrants dated September 10, 2010 and priced at $1.01 per warrant.

The above description is qualified in its entirety by reference to the subscription agreements and entered into by Mr. Landegger and The Whittemore Collection, Ltd., on the one hand, and the Company, on the other hand, effective November 21, 2011 and the warrants issued to each subscriber. Copies of the forms of subscription agreement and warrant are attached as Exhibits 10.1 and 4.1, respectively, to this current report and are incorporated herein by reference.

SunTrust Robinson Humphrey, Inc. provided financial advisory services to Guided Therapeutics, Inc in conjunction with the financing and received compensation in the aggregate amount of $75,000.

Item 3.02. Unregistered Sales of Equity Securities.The information disclosed in Item 1.01 of this current report is incorporated in this Item 3.02 by reference. All of the Shares and the Warrants were offered and sold by the Company pursuant to an exemption from the registration requirements of the Securities Act 1933, as amended, provided by Section 4(2) thereof and Rule 506 of Regulation D, promulgated thereunder, as a transaction with accredited investors not involving a public offering.

[caly] Guided Therapeutics Reports Update on FDA Review of LuViva™ Advanced Cervical Sc...

caly — 11/2/2011 7:39:32 PM

Guided Therapeutics Reports Update on FDA Review of LuViva™ Advanced Cervical Scan PMA Application

Panel review of technology no longer planned for FDA decision

Press Release Source: Guided Therapeutics, Inc. On Wednesday November 2, 2011, 10:00 am EDT

NORCROSS, Ga.--(BUSINESS WIRE)-- Guided Therapeutics, Inc.(OTCBB & OTCQB: GTHP) today announced the U.S. Food and Drug Administration (FDA) has informed the company that the agency is not planning a panel review to render a decision on the Premarket Approval (PMA) application of the LuViva™ Advanced Cervical Scan.

The FDA acknowledged that it had previously stated that there would be a panel review, but, in a conference call with the company, said that after further review of the PMA application a review by an outside panel of experts was not needed. According to the FDA, this decision does not affect the likelihood of approval or disapproval and the PMA review is continuing. The reasons given by FDA for not requiring a panel meeting were: that the agency staff believed they understood LuViva’s technology, that they understood the clinical application and had reviewed similar devices in the past.

“While this new position from FDA is not an indication of the likelihood of approval or disapproval of the LuViva application, we believe that it could shorten the time frame for a final decision by the agency, based on our previous expectations,” said Mark L. Faupel, Ph.D., CEO and President of Guided Therapeutics, Inc. “We will continue to work with FDA on the premarket approval process and, while we await a decision, we are preparing for any further FDA requirements, such as manufacturing or other facility audits or inspections.”

“Concurrently, our team is preparing the documentation for the CE Mark application and we look forward to meeting with our new international distributors and European doctors, all leaders in the field of women’s health, at the upcoming 2011 Medica Trade Fair in Germany later this month,” said Dr. Faupel.

Based on FDA guidelines, the company expects a decision from FDA by January 20, 2012. While the panel meeting is no longer planned, if there is a panel review at a future date, Guided Therapeutics believes it will be prepared to present the technology.

About LuViva

LuViva scans the cervix with light to identify cancer and pre-cancer painlessly and non-invasively. Unlike Pap or HPV tests, 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 in a referred population which has undergone initial screening and is called back for follow up - called a colposcopy examination - which in many cases involves taking a biopsy of the cervix.

[caly] Former Delta Air Lines CEO Named Guided Therapeutics Chairman Press Release Sour...

caly — 8/17/2011 10:14:26 AM

Former Delta Air Lines CEO Named Guided Therapeutics Chairman
Press Release Source: Guided Therapeutics, Inc. On Wednesday August 17, 2011, 8:30 am EDT

NORCROSS, Ga.--(BUSINESS WIRE)-- Guided Therapeutics, Inc.(OTCBB & OTCQB: GTHP), developer of a rapid and painless testing platform that uses biophotonics for the early detection of disease, today named a Chairman and Vice Chairman of its Board of Directors.

Ronald W. Allen, 69, former Chairman and Chief Executive Officer of Delta Airlines, Inc., was elected Chairman of the Company’s Board of Directors. Mr. Allen replaces Chairman William Zachary, Jr., who retired. Ronald W. Hart, Ph.D., 69, former U.S. Food and Drug Administration Center Director, was named Vice-Chairman of the Board. Both Mr. Allen and Dr. Hart are existing directors of the six-member Board.

“I believe that Guided Therapeutics is poised to make great strides in the war on cancer, starting with non-invasive cervical cancer detection,” said Mr. Allen. “These times demand that new technology not only address unmet medical needs, but does so in a way that reduces costs and brings efficiency to the healthcare system. I believe that Guided Therapeutics’ technology offers a new level of care and an opportunity to bring substantial savings to the world’s healthcare system. I look forward to working with management to bring this exciting technology to market.”

Guided Therapeutics’ CEO and President, Mark L. Faupel, Ph.D., commented, “Both Mr. Allen and Dr. Hart bring a wealth of experience and energy to the Board. Their contributions are substantial and meaningful, and we look forward to their leadership.”

Mr. Allen was named to the Company’s Board in September 2008. Mr. Allen retired as Delta’s Chairman of the Board, President and Chief Executive Officer in July 1997 after having held those positions since 1987. He is a Director of The Coca-Cola Company, Aaron Rents, Inc., Aircastle Limited and Forward Air Corporation. He is also a board member of the St. Joseph’s Translational Research Institute, which endeavors to turn new medical discoveries into tangible cures.

Dr. Hart has served as a member of Guided Therapeutics’ Board of Directors since March 2007. He has published over 600 peer-reviewed publications. In 1980, Dr. Hart was appointed Director of the National Center for Toxicological Research, the research arm of the FDA, a position he held until 1992. In 1992, Dr. Hart was the first ever Presidential Appointee to the position of Distinguished Scientist in Residence for the U.S. Public Health Service/FDA, a position he held until his retirement in 2000. Dr. Hart currently serves on the Boards of Directors of Motor Excellence, St. Renatus, SNTech, Inc., AeroFarms, Inc., and GeoTherm, Inc., and has helped in the development of business strategy for a number of start-up companies.

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 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 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 LuViva Advanced Cervical Scan and Barrett’s Esophagus technology are investigational devices and are limited by federal law to investigational use.