Ultime notizie per Guided Therapeutics (OTC:GTHP) Azioni

Guided Therapeutics

GUIDED THERAPEUTICS INC by Guided Therapeutics, Inc.

Guided Therapeutics Inc is a medical technology company. It is engaged in developing medical devices that have the potential to improve healthcare. Its primary focus is the sales and marketing of its LuViva Advanced Cervical Scan non-invasive cervical cancer detection device and extension of its cancer detection technology into other cancers, including esophageal. The company generates revenue from the sale of medical devices.

GUIDED THERAPEUTCS INC by Guided Therapeutics, Inc.

Guided Therapeutics Inc

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GTHP

Guided Therapeutics Reports Q3 EPS ($0.02) vs. Prior Year Quarter ($0.04)

Guided Therapeutics Reports Q4 EPS -$0.04, No Estimates Available

Guided Therapeutics, Inc. (OTCBB: <a class="ticker" href="/stock/gthp#OTCBB">GTHP</a>) (OTCQB: GTHP) today announced that it has submitted the application for CE Mark approval for LuViva® Advanced Cervical Scan. The CE Mark is required to market LuViva in the 27 nations that comprise the European Union (<a class="ticker" href="/stock/eu#">EU</a>). 

"The filing of our CE Mark approval application for LuViva is a significant milestone for the company and puts us on track, when approved, for a full-scale European launch in the third quarter of this year," said Mark L. Faupel, Ph.D., president and CEO of Guided Therapeutics. “We view the international market segment as significant opportunity for LuViva because of the product's versatility and ability to adapt to the various diagnostic routines in different countries.” 

Distribution agreements are currently in various stages of completion for several EU and Asian countries, including Germany, the United Kingdom and several South Asian countries. The company also has initial orders for clinical and demonstrations units in hand for European and Asian countries.

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Guided Therapeutics Submits CE Mark Approval Application for LuViva® Advanced Cervical Scan   

Shares of Guided Therapeutics (OTC: <a class="ticker" href="/stock/gthp#OTC">GTHP</a>) rose as high as $1.52 and closed 22% higher at $1.43 on Friday after <a _fcksavedurl="http://www.biomedreports.com/2011120985435/chatter-concerning-upcoming-fda-decision.html" href="http://www.biomedreports.com/2011120985435/chatter-concerning-upcoming-fda-decision.html" rel="nofollow" target="_blank">we reported to our premium subscribers</a> that the firm is awaiting a key approval decision from the FDA in regards to their LuViva&trade; Advanced Cervical Scan technology device.

	A day earlier on Thursday, shares of GTHP also saw double growth and closed at $1.17 after news that the National Cancer Institute (<a class="ticker" href="/stock/nci#">NCI</a>) had designated the firm&#39;s LuViva&trade;&nbsp; as one of the agency&rsquo;s successful investments for developing innovative products to fight cancer, but we are hearing credible chatter that the company may be getting some good news in regards to their pending FDA decision.

	For those of you not familiar with the company, Guided Therapeutics developed Biophotonics technology that is used in medicine to study tissue and blood at the macro (large-scale) and micro (very small scale) organism level to detect, diagnose and treat diseases in a way that are non-invasive to the body. Its LuViva&trade; Advanced Cervical Scan uses light to detect chemical and structural changes in cervical tissue. The technology being developed for the cancer product is called hyperspectral imaging spectroscopy or HIS. HIS acquires the individual spectrum of each cell component while it is in the body. The device then identifies physiological markers of cancer based on their spectral signatures.

	LuViva is currently under U.S. Food and Drug Administration (FDA) premarket application review and our <a _fcksavedurl="http://www.biomedreports.com/fdacal.html" href="http://www.biomedreports.com/fdacal.html" rel="nofollow" target="_blank">BioMedReports FDA Calendar</a> shows that the FDA has informed Guided Therapeutics that the agency expects to rule on the application <a _fcksavedurl="http://www.biomedreports.com/fdacal.html" href="http://www.biomedreports.com/fdacal.html" rel="nofollow" target="_blank">by January 20, 2012</a>, but a decision could come much sooner according to our sources.

	Shares traded nearly seven times the daily average volume and closed at the three-year resistance levels. If the stock breaks past those resistance levels, it could see another effusive run, particularly if the firm recives news from U.S. regulators early. Strong positive news would likely impact the firm&#39;s conservatively priced ($70M) market cap, especially given the increasingly tigher float. total outstanding shares (roughly 49 million).
	<img _fcksavedurl="http://www.biomedreports.com/images/stories/charts/gthp12-11-2011.jpg" src="http://www.biomedreports.com/images/stories/charts/gthp12-11-2011.jpg" />
	As biotech specuilators know, the valuations of these medical device diagnostics companies usually increase significantly after an FDA approval and <a _fcksavedurl="http://www.genomeweb.com/dxpgx/ge-healthcare-acquire-clarient-580m" href="http://www.genomeweb.com/dxpgx/ge-healthcare-acquire-clarient-580m" rel="nofollow" target="_blank">acquisition by leaders in the space</a> who can combine, market and accelerate the development of new integrated tools for diagnosis under their own umbrella becomes far more likely.
	&ldquo;We are honored that LuViva has been acknowledged as a successful investment by the world&rsquo;s leading cancer research organization,&rdquo; <a _fcksavedurl="http://finance.yahoo.com/news/National-Cancer-Institute-bw-2791052288.html?x=0" href="http://finance.yahoo.com/news/National-Cancer-Institute-bw-2791052288.html?x=0" rel="nofollow" target="_blank">said CEO and president Mark L. Faupel, Ph.D., yesterday</a>. &ldquo;This recognition underscores LuViva&rsquo;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.&rdquo;
	LuViva&trade; identifies cancers and precancers quickly by analyzing light reflected from the cervix. The device creates an image of the cervix for the doctor that highlights the location and severity of disease. More than 1,600 women at risk for cervical disease were tested with the LuViva&trade; in a multi-center pivotal clinical trial. <a _fcksavedurl="http://www.guidedinc.com/Publications.htm" href="http://www.guidedinc.com/Publications.htm" rel="nofollow" target="_blank">Results of the trial</a> showed that:
<ul>
<li>
		&nbsp;&nbsp;&nbsp; LuViva&trade; detected cervical disease up to two years earlier than Pap test, HPV test, colposcopy and biopsy.</li>
<li>
		&nbsp;&nbsp;&nbsp; LuViva&trade; detected 86.3% cervical disease cases that had been missed by Pap, HPV (human papillomavirus) tests and biopsy.</li>
<li>
		&nbsp;&nbsp;&nbsp; LuViva&trade; would have reduced the number of unnecessary biopsies by about 40 percent.</li>
</ul>

	Additionally, the clinical trials indicated that women aged 16-20 were just as likely to have cervical disease as women 21 and older and current methods of early detection, such as HPV testing, are not recommended for this age group. LuViva detected cervical disease equally well in both adolescent and adult women.

	In August <a _fcksavedurl="http://www.guidedinc.com/News/Barretts%20Feasibility%20August%2010%202011.pdf" href="http://www.guidedinc.com/News/Barretts%20Feasibility%20August%2010%202011.pdf" rel="nofollow" target="_blank">the firm announced</a> that it began human testing of its light-based detection technology for Barrett&rsquo;s Esophagus, a precursor for esophageal cancer. That technology is being jointly developed with Konica Minolta Opto of Japan.

Markets

Guided Therapeutics' Shares Ahead of Pending FDA Decision

Guided Therapeutics, Inc. (OTC: GTHP) today announced that it has answered all key questions from the U.S. Food and Drug Administration (FDA) regarding the company's premarket approval application for the LuViva™ Advanced Cervical Scan. 

“We are pleased to provide the FDA with the additional information the agency requested and within the time period required to maintain the PMA application under active review,” said Mark L. Faupel, Ph.D., President and CEO of Guided Therapeutics. “The FDA will review our submission, we hope move forward with the PMA process and schedule a panel meeting date, although the agency has the option to ask for additional information.”

Guided Therapeutics Answers FDA Questions for LuViva™ Advanced Cervical Scan PMA   

Press Releases

Guided Therapeutics Announces Completion of Clinical Study for Chinese Regulatory Approval

Leading Cervical Cancer Doctors Support Approval of LuViva in China Based on Preliminary Review of Clinical Trial Results

Mannatech Announces Appointment of James Clavijo as Chief Financial Officer

Guided Therapeutics' Announces Data from Chinese NMPA Clinical Study Signed Off by All Four Clinical Sites With Better Than Expected Results

Guided Therapeutics Announces Filing of Application for NMPA Approval to Market and Sell LuViva in China

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