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   Biotech / MedicalGuided Therapeutics - GTHP


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From: caly1/20/2012 6:08:16 PM
   of 118
 
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.

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To: caly who wrote (116)1/31/2012 11:44:03 AM
From: caly
   of 118
 
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

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From: caly7/18/2012 12:07:49 PM
   of 118
 
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.

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