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From: caly6/3/2011 4:12:16 PM
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sec.gov 

On June 1, 2011, William Zachary, the Chairman of the Company's board of directors, informed the Company that he would not stand for reelection at the next annual meeting of shareholders.

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From: caly6/20/2011 11:07:51 AM
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projectreporter.nih.gov 

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From: caly7/6/2011 11:02:04 AM
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We might be starting to see PPS creep as September nears. Note the FDA Panel meeting has been moved up two weeks and is now in early September vs. late September.

fda.gov 

September 8-9 - Obstetrics and Gynecology Devices Panel

No agenda has been posted yet:

fda.gov 

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From: caly7/15/2011 3:06:16 PM
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The rescheduled meeting of the Ob/Gyn Panel is now off the schedule. It sounds like it will be scheduled when the GTHP product is ready to be reviewed.

Guided Therapeutics Provides Progress Update on its Response to FDA Questions

Press Release Source: Guided Therapeutics, Inc. On Thursday July 14, 2011, 9:50 am EDT

NORCROSS, Ga.--(BUSINESS WIRE)-- Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP), developer of a rapid and painless biophotonic testing platform for the early detection of cancer, today announced that, after a series of meetings with the U.S. Food and Drug Administration (FDA), and after reviewing draft responses, the FDA has asked the company to provide additional information in the company’s response to one remaining question. The company expects to be able to adequately provide the additional information in a timely manner.

The LuViva is under FDA premarket approval (PMA) review for use as a test after initial screening for cervical disease. As part of the review, the company received a series of questions from the FDA regarding the PMA application earlier in the year.

“We believe that we have made considerable progress in working with the FDA toward scheduling a panel review meeting that would continue to support an early 2012 U.S. launch of the LuViva, assuming we receive approval,” said Mark L. Faupel, CEO and president of Guided Therapeutics, Inc. “While a September PMA panel meeting is no longer scheduled, the company anticipates requesting a panel meeting as soon as possible thereafter, barring any additional questions, or requests, from the FDA.”

“Plans remain in place for a late 2011, or early 2012 international launch and we plan on announcing additional partnerships and additional progress on the international front in the coming weeks and months,” Dr. Faupel said.

Cervical Cancer is a Global Problem

According to the World Health Organization, the world has a population of 2.3 billion women ages 15 years and older who are at risk of developing cervical cancer. Current estimates indicate that every year 529,828 women are diagnosed with cervical cancer and 275,128 die from the disease.

About The Technology Platform

The Guided Therapeutics biophotonic disease detection platform, which consists of a base unit and single-patient-use calibration disposable, scans tissue with light to identify cancer and pre-cancer painlessly and non-invasively. The proprietary, patented biophotonic technology is able to distinguish between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike traditional 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 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.

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From: caly8/17/2011 10:14:26 AM
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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.

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From: caly11/2/2011 7:39:32 PM
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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.

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From: caly11/28/2011 12:29:19 PM
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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.

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From: caly12/9/2011 12:07:05 PM
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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.

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To: caly who wrote (109)12/9/2011 12:10:14 PM
From: caly
   of 118
 
Be it a coincidence or not, January, the assumed month of FDA approval, is National Cervical Health Awareness Month.

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From: caly12/14/2011 2:46:22 PM
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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 .

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