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   Biotech / MedicalGuided Therapeutics - GTHP


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From: caly1/10/2011 11:05:13 PM
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SeekingAlpha write-up:

seekingalpha.com

"The FDA is expected to schedule the Obstetrics and Gynecology Panel meeting to review this PMA at a date to be determined (most likely within the next 90 days)."

I hope he's about about this, because the next Ob/Gyn panel meeting is shown on the schedule as being in May.

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To: caly who wrote (84)1/14/2011 12:16:02 PM
From: caly
   of 118
 
Significant volume and price move today on no news. Large buys coming in.

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From: caly1/14/2011 3:31:08 PM
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Today's run-up explained by a Yahoo poster. The stock was written up on biorunup.com

messages.finance.yahoo.com

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From: caly1/15/2011 11:17:52 AM
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There have been some additional posts on the Yahoo thread by biorunup subscribers. I think the bottom line here is that the biorunup rec has brought some exposure to the stock, and perhaps some long-term investors, but what we can expect most from it is volatility as the subscribers enter and exit as we get closer to panel meeting date.

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To: caly who wrote (87)1/15/2011 11:55:14 PM
From: caly
   of 118
 
One of the guys from biorunup made a post on the Yahoo board:

messages.finance.yahoo.com

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From: caly1/27/2011 11:21:55 AM
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Guided Therapeutics Receives ISO Certification

Paves the way for CE Mark for Cervical Pre-cancer Scanner

Press Release Source: Guided Therapeutics, Inc. On Thursday January 27, 2011, 9:33 am EST

NORCROSS, Ga.--(BUSINESS WIRE)-- Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP), developer of the LightTouch™, a rapid, non-invasive and painless test for the early detection of cervical pre-cancer currently under review at the FDA, today announced that it was awarded ISO 13485:2003 registration certification.

“Receiving this certification is a very important milestone for the company and its shareholders and paves the way for the future sale of our products in the European Union and other countries that recognize the importance of the CE mark,” said Mark L. Faupel, CEO and president of Guided Therapeutics, Inc. “We believe that the LightTouch has significant market potential outside the U.S. and this certification demonstrates that the company has created a high-quality and world-class organization for the design, manufacture and distribution of our products internationally. I congratulate all the members of the Guided Therapeutics team that put so much effort into this successful process.”

The certificate of registration was issued by Intertek Testing Services NA Ltd. Intertek is a leading provider of quality and safety solutions, serving a wide range of industries around the world. For more information, visit www.intertek.com.

The International Organization for Standardization (ISO) is a non-governmental organization. Established in 1947, ISO currently works with the national standards institutes of over 140 countries to establish international standards. These standards are established to meet the needs of business and society. For more information, visit iso.org.

To view the certificate, visit guidedinc.com

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From: caly2/9/2011 4:08:36 PM
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In the category of FWIW, this recent update on the FDA website clearly states that the FDA seeks advice from an advisory panel at their discretion. The next meeting of the FDA's Ob/Gyn Devices Advisory Panel isn't until May.

fda.gov

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From: caly2/25/2011 9:47:50 AM
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Guided Therapeutics’ Cervical Disease Detection Technology to be the Subject of a Presentation at the Upcoming ACOG Annual Meeting

Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP) today announced that its non-invasive and painless test for the early detection of cervical precancer, the LightTouch™, will be the subject of a presentation 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 presentation, Study Results of a New Test for Cervical Dysplasia: Potential Impact on Patient Management, is scheduled to be presented by Dr. Leo B. Twiggs, professor in the Department of Obstetrics and Gynecology at the University of Miami, Miller School of Medicine on Monday, May 2nd from 2 p.m. to 4 p.m. Dr. Twiggs was a principal investigator in the pivotal clinical trial of the technology.

“This is the second major international scientific meeting to accept our technology for presentation to prominent thought leaders in the field of women’s health,” said Mark L. Faupel, CEO and president of Guided Therapeutics, Inc.

LightTouch, used as a triage test, would detect approximately 170,000 more women each year who have CIN2+, a diagnosis that places them at high risk for developing cancer of the cervix, while also reducing the number of unnecessary biopsies by more than 1 million, according to the study’s conclusions.

The technology is currently under Food and Drug Administration premarket approval review. Guided Therapeutics was recently awarded ISO 13485 certification for its quality system, a precursor for the CE mark required for sales in the European Union. The technology is also planned for a presentation at the EUROGIN scientific meeting in Lisbon in May, 2011.

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 The LightTouch™

The LightTouch, 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 LightTouch 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 product, the LightTouch™, is 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 LightTouch was able to detect cervical cancer up to two years earlier than conventional modalities. LightTouch is designed to provide an objective result at the point-of-care, thereby improving the management of cervical disease. Guided Therapeutics has also entered into a partnership with Konica Minolta Opto to develop a non-invasive test for Barrett’s Esophagus using the LightTouch technology platform. For more information, visit: www.guidedinc.com.

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From: caly3/7/2011 9:46:00 AM
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Guided Therapeutics Granted Approval for Human Clinical Studies of Light-based Test for Barrett’s Esophagus Pipeline Product
Institutional Review Board rules test is non-significant risk to patients

GTHP.OB 1.33 0.00

Press Release Source: Guided Therapeutics, Inc. On Monday March 7, 2011, 8:30 am EST

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 announced that it has received Institutional Review Board (IRB) approval to begin testing its light-based detection technology in humans for Barrett’s Esophagus, a precursor for esophageal cancer. The IRB also categorized the technology as “non-significant risk,” which indicates the technology is fundamentally safe when used as directed.

“We are excited to move ahead with the second product based on our patented light-based, disease detection platform,” said Mark L. Faupel, CEO and president of Guided Therapeutics, Inc. “Receiving IRB approval, as well as being classified as “non-significant risk,” are both very important achievements for advancing this product extension. Our next milestones will be to complete the development of our prototypes and begin the first clinical study, which we expect to initiate in the second or third quarter of 2011.”

The new product for the detection of Barrett’s Esophagus, a precursor for esophageal cancer, is being co-developed with Konica Minolta Opto, Inc. of Japan and is based on the company’s LightTouch™ non-invasive cervical cancer detection technology, which is undergoing the U.S. Food and Drug Administration’s premarket approval process.

According to the World Health Organization (WHO), esophageal cancer ranks just below cervical cancer in newly diagnosed cases. New cases of esophageal cancer are estimated at 410,000 worldwide, with more than 16,000 new cases a year and more than 14,000 deaths in the U.S. alone. Barrett’s esophagus is believed to be caused by excessive acid reflux.

About The Technology Platform

The LightTouch 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.

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From: caly3/7/2011 10:37:08 AM
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And the reason for the dump today...

Guided Therapeutics Provides Update on FDA PMA Review of Cervical Cancer Test

Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP), today provided an update on the U.S. Food and Drug Administration (FDA) review process for its premarket approval application (PMA) for the LightTouch™ non-invasive test for the early detection of cervical pre-cancer. The PMA was accepted for filing as of September 23, 2010.

The FDA has inspected two clinical trial sites as part of its review process and raised no formal compliance issues. Advanced Scientifics, Inc. (ASI), the manufacturer of the Company’s single-patient-use disposable patient interface, also reported a successful FDA inspection.

As is typical in the FDA review process, the Company also received a series of questions from the FDA regarding the PMA, covering the clinical trial and various technical issues, for which the Company has 180 days to respond.

“We are pleased with the results of the FDA’s review of our clinical sites and that of our contract manufacturer, ASI,” said Mark L. Faupel, Ph.D., CEO and President of Guided Therapeutics, Inc. “We fully expect to answer the FDA’s questions in a timely manner. Given the timing of the FDA’s inspections and questions, though, it now appears less likely we will be part of the next Obstetrics and Gynecology Devices Panel meeting, tentatively scheduled for May 19-20, 2011.

“Still, we believe it is possible to meet our target for a year end 2011 or early 2012 launch in the U.S. with the next currently scheduled panel meeting date in September, 2011. This would assume the FDA’s questions are answered successfully, any additional inspections also are successful and final approval is granted. Meanwhile, we also continue to work toward an international launch, which could occur prior to approval in the U.S.,” Dr. Faupel said.

About The LightTouch™

The LightTouch, 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 LightTouch test does not require laboratory analysis or a tissue sample, is designed to provide results immediately and eliminate costly unnecessary testing.

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