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Guided Therapeutics, Inc. Announces Completion Of Subject Enrollment Of FDA Pivotal Clinical Trial

Guided Therapeutics, Inc. (GT) (Pink Sheets: GTHP) today announced completion of its U.S. Food and Drug Administration (FDA) pivotal clinical trial for its LightTouch TM non-invasive cervical cancer detection device.

The GT LightTouch technology systematically and rapidly scans the cervix to identify cancers and pre-cancers painlessly and non-invasively by analyzing the wavelengths of light reflected from cervical tissue. Since the pivotal trial began, approximately 1,900 women have been tested to demonstrate the technology's accuracy in detecting cervical disease, including an arm of the study that assessed effectiveness of the commercial version of the device and single-use disposable. The technology has already undergone safety evaluations by FDA and is considered to be non-significant risk by hospital institutional review boards.

"Completing subject enrollment in our pivotal FDA clinical trial is a major milestone in product development," said Mark L. Faupel, Ph.D., GT President and CEO. "I want to thank our principal investigators, their staff and the women who participated in the trial. Our next steps are to analyze the results and to file our premarket approval application with the FDA."

The clinical trial sites include the University of Miami, The University of Texas Southwest, Emory University/Grady Memorial Hospital in Atlanta, the Medical College of Georgia in Augusta, GA, St. Francis Hospital/University of Connecticut in Hartford, Orange Coast Women's Center and Saddleback Women's Center in California.

"The LightTouch has the potential to help detect cervical disease before it becomes life threatening," said Dr. Leo B. Twiggs, Professor and Chair Ob/Gyn University of Miami Miller School of Medicine and a principal investigator in the study. Early detection and treatment are the best ways to increase survival and preserve the reproductive health for women."

According to studies published in the peer-reviewed Journal of Lower Genital Tract Disease, the non-invasive LightTouch test has the potential to be significantly more accurate when compared to the Pap test and Human Papilloma Virus test, two standard tests women currently undergo for cervical screening and diagnosis.

"Based on our experience during the clinical trial, I believe that my patients would overwhelmingly favor LightTouch over the current standard of care because it is less painful and is designed to provide an immediate result," said Dr. Marc Winter of Orange Coast Women's Center. Dr. Daniel Sternfeld of Saddleback Women's Center added, "Because LightTouch is cost effective and easy to implement in a broad range of clinical environments, it has the potential to transform how cervical disease is managed."

The LightTouch uses proprietary technology to identify cancers and precancers painlessly and non-invasively by analyzing light reflected from the cervix. The technology distinguishes between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the non-invasive test does not require a tissue sample or laboratory analysis, and results are available immediately. In all, nearly 3,000 women have enrolled in studies using prototypes of the non-invasive cervical cancer detection device with no instances of significant or unexpected adverse events. Research and commercialization of the device were funded, in part, by grants from the National Cancer Institute and Georgia Research Alliance.

About Guided Therapeutics

Guided Therapeutics, Inc. (Pink Sheets: GTHP) is developing a rapid and painless test for the early detection of disease that leads to cervical cancer. The technology is designed to quickly eliminate false positive Pap and HPV results and discover cervical disease missed by existing tests. Unlike Pap and HPV tests, the device does not require a painful tissue sample and results are known immediately. The company also owns technology for measuring substances in interstitial fluid, a secondary circulatory system in the body that surrounds the cells. For more information, visit GT's web site http://www.guidedtherapeutics.com.

The Guided Therapeutics LightTouch™ Non-invasive Cervical Cancer Detection Device is an investigational device and is limited by federal law to investigational use.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995

A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics' actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include: the early stage of products in development, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the uncertainty of capital to develop products, the uncertainty of regulatory approval of products, dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading "Risk Factors" in Guided Therapeutics' reports filed with the SEC, including Guided Therapeutics's Annual Report on Form 10-KA for the fiscal year ended December 31, 2007.

Guided Therapeutics, Inc.





Asistat Therapeutics, Inc anunþã finalizarea subiect de înscriere de FDA Studiul clinic pivot - Guided Therapeutics, Inc. Announces Completion Of Subject Enrollment Of FDA Pivotal Clinical Trial - articole medicale engleza - startsanatate