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   Biotech / MedicalGuided Therapeutics - GTHP


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From: caly4/28/2011 11:40:32 AM
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Guided Therapeutics to Unveil Cervical Disease Detection Technology New Design and Branding at ACOG and EUROGIN Meetings
Principal investigators to present results of FDA clinical trials

Press Release Source: Guided Therapeutics, Inc. On Wednesday April 27, 2011, 9:05 am EDT

NORCROSS, Ga.--(BUSINESS WIRE)-- Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP), announced that it will present the new design and branding of its non-invasive and painless test for the early detection of cervical precancer at two upcoming international gynecology conferences. Additionally, attendees will be briefed on results of the pivotal clinical trial of the technology by two principal investigators.

“We are excited about the new design and branding for the cervical detection technology and believe it will be well received,” said Mark L. Faupel, Ph.D., CEO and President of Guided Therapeutics, Inc. “We are also pleased to have two of our principal investigators scheduled to present findings of our clinical trial to such prestigious medical conferences.”

Dr. Leo B. Twiggs, professor in the Department of Obstetrics and Gynecology at the University of Miami, Miller School of Medicine, is scheduled to present Study Results of a New Test for Cervical Dysplasia: Potential Impact on Patient Management, on Monday, May 2nd from 2 p.m. to 4 p.m. at The American College of Obstetricians and Gynecologists (ACOG) 59th Annual Clinical Meeting to be held April 30 - May 4, 2011 in Washington, DC. The company will display the design and brand at booth 621 beginning Monday, May 2nd.

Dr. Lisa Flowers, of Emory University and Grady Hospital of Atlanta, is scheduled to present Introducing a New Diagnostic Modality into the Standard of Care at the EUROGIN scientific meeting in Lisbon, Portugal on Tuesday, May 10th from 9:30 a.m. to 11:00 a.m. The company will display the design and brand at booth 4.13 beginning Sunday, May 8th.

The technology, which consists of a base unit and single-patient-use calibration disposable, 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, the Guided Therapeutics test does not require laboratory analysis or a tissue sample, is designed to provide results immediately and eliminate costly unnecessary testing.

The technology is currently under U.S. Food and Drug Administration premarket approval review. In January 2011, Guided Therapeutics was awarded ISO 13485 certification for its quality system, a precursor for the CE mark required for sales in the European Union.

About ACOG

Founded in 1951 in Chicago, Illinois, ACOG has over 52,000 members and is the nation's leading group of professionals providing health care for women. Now based in Washington, DC, it is a private, voluntary, nonprofit membership organization. For more information, visit www.acog.org.

About EUROGIN

EUROGIN (EUropean Research Organisation on Genital Infection and Neoplasia) brings together clinicians and scientists whose work is related to genital infections and neoplasia. The aims of the organization are to promote and develop, at a European level, research, training, screening, prevention and information concerning genital infections, precancers and cancers in women. Developed as a result of a common European resolution, EUROGIN brings together representatives of all the specialist areas concerned: gynaecologists, dermatologists, pathologists, biologists, oncologists and basic scientists. For more information, visit www.eurogin.com/2011/.

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From: caly5/16/2011 4:00:02 PM
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10Q Filed:

sec.gov

LuViva™ (formerly LightTouch)

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From: caly5/18/2011 11:12:19 PM
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HPV test beats Pap for cervical cancer screening

news.yahoo.com

By MARILYNN MARCHIONE, AP Medical Writer – Wed May 18, 6:06 pm ET

Two big studies suggest possible new ways to screen healthy people for cervical or prostate cancers, but a third disappointed those hoping for a way to detect early signs of deadly ovarian tumors.

Researchers found:

_For women 30 and over, a test for the virus, HPV, is better than a Pap smear for predicting cervical cancer risk, and those who test negative on both can safely wait three years to be screened again.

_A single PSA blood test at ages 44 to 50 might help predict a man's risk of developing advanced prostate cancer or dying of it up to 30 years later. The PSA test is notoriously unreliable, but using it this way separates men who need a close watch from those who are so low-risk that they can skip testing for five years or more.

_Screening women with no symptoms for ovarian cancer with a blood test and an ultrasound exam is harmful. It didn't prevent deaths and led to thousands of false alarms, unneeded surgeries and serious complications.

The last study is a warning to people who get screening tests that aren't recommended, or who question whether screening can ever hurt.

"The answer is, it could hurt a lot," said Dr. Allen Lichter, chief executive of the American Society of Clinical Oncology. The group published these and 4,000 other studies Wednesday, ahead of its annual meeting next month.

Cervical cancer is easy to prevent. It's very slow-growing and screening finds precancerous cells and allows early treatment. The new study was the first big one to examine a newer screening tool, HPV tests, with or without Pap smears in routine practice.

For a Pap test, cells scraped from the cervix, the gateway to the uterus, are checked under a microscope. But this can miss problems or raise false alarms.

HPV tests detect the human papillomavirus, which causes most cases of cervical cancer. But HPV is "the common cold" of the nether regions — most sexually active young people have been exposed to it, said Debbie Saslow, the American Cancer Society's director of breast and gynecologic cancer. Most infections go away on their own; they're only a cancer risk when they last a year or more.

Younger women tend to have short-term infections, so Pap tests are a better way to screen them. HPV tests are approved as an option along with Paps for women 30 and older, and the cancer society says that if a woman tests negative on both, she can wait three years to be screened again. Few take this advice, though.

"Women still want their annual Pap and doctors still want to give them," and think it's rationing care to test less often, Saslow said.

The new study gives "very, very solid support" for screening less often, Lichter said.

Hormuzd Katki of the National Cancer Institute studied more than 330,000 women getting HPV and Pap tests through Kaiser Permanente Northern California for five years.

Only about three out of 100,000 women each year developed cervical cancer after negative HPV and Pap tests. HPV tests were twice as good as Paps for predicting risk. Adding a Pap after a negative HPV test did little to improve risk prediction.

However, if an HPV test was positive, a Pap test helped confirm or rule out the need for follow-up.

The study didn't look at the downside of HPV testing — how many false alarms and needless procedures it triggered. HPV tests cost $80 to $100 compared to $20 to $40 for Paps.

The prostate study sought a better way to use PSA tests, which are troublesome because PSA can be high for many reasons besides cancer, and doctors don't know which cancers need treatment or whether screening saves lives. Most groups don't recommend PSA tests, but most men over 50 get them anyway.
The new study "is not going to end the controversy, but it suggests a very interesting middle ground," Lichter said.
Researchers at Memorial Sloan-Kettering Cancer Center in New York used stored blood samples that 12,000 Swedish men gave for a heart study decades ago, when most were 44 to 50 years old. They also had second samples from some of them six years later, and samples from other 60-year-old men.

Looking 27 years later, researchers saw that 44 percent of cancer deaths occurred in men whose initial PSAs had been in the top 10 percent when they were 44 to 50 years old.
Conversely, scoring below the median meant very little cancer risk years later.

"They're identifying a group of guys who don't need to be screened, or need to be screened less often," said Dr. Otis Brawley, the cancer society's chief medical officer.
The results are "provocative," but this type of study can't prove that screening prevents deaths, said Dr. Matthew R. Smith of the Massachusetts General Hospital Cancer Center. Few of the Swedish men were treated for prostate cancer as most men are today, which can affect survival.

The National Cancer Institute, the Swedish Cancer Society and several foundations paid for the work, and one researcher holds patents for two PSA-related tests.

Baseline PSA tests for men in their 40s can't be recommended yet, Brawley said. The cancer society says men should be informed of the risks and benefits of PSA tests starting at age 50, and sooner for blacks and those with family history of prostate cancer.

The government-funded ovarian cancer study involved nearly 80,000 women. Half were screened annually with an ultrasound for four years and a blood test for six years. The blood test looked for CA-125, a substance often elevated in ovarian cancer.

After 13 years, there were no major differences in ovarian cancers found or deaths from the disease. Screening found only 212 cancers while giving 3,285 false alarms that led to 1,080 unneeded biopsy surgeries and 163 serious complications.
"So many people say `how can cancer screening be harmful?' This thing documents it," Brawley said.

The results don't apply to using these tests on women with symptoms of ovarian cancer or abnormal physical exams. That's still the best way to check for ovarian cancer in those cases.

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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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