Message #11 From:
Stock News Bot Date: January 4, 2006 03:00:00 AM
SPRX News SpectRx, Inc. Successfully Builds and Tests First Pre-production Non-invasive Cervical Cancer Detection Device; New Devices and Single-Patient-Use Disposables to Complete FDA Pivotal Clinical Trial
NORCROSS, Ga.--(BUSINESS WIRE)--Jan. 4, 2006--SpectRx, Inc. (OTCBB: SPRX) today announced that it successfully built and tested its first pre-production non-invasive cervical cancer detection device. The next-generation device contains major components planned for use in commercial production and is to be used to complete the ongoing U.S. Food and Drug Administration (FDA) pivotal clinical trial necessary for regulatory approval.
"Completion of this beta device, and single-patient-use disposables, is a major milestone in the process of bringing this unique technology to market," said Mark Faupel, president and chief operating officer of Guided Therapeutics, Inc., the SpectRx subsidiary company formed to commercialize the non-invasive cervical cancer detection device. "We are pleased with the initial technical performance of the pre-production device and single use disposable, both of which benefit from advances in our patented technology and component optimization. Additionally, we believe that this new-generation system will enable us to reach our price-of-production goals, thus making the technology affordable to the general Ob-Gyn and family practice physician."
"We anticipate placing the first new device in the pivotal clinical trial early this year followed by additional beta units. These new devices will allow us to close out the human data collection phase of the FDA trial and begin preparation of the important clinical data section of the premarket approval (PMA) application," said Mr. Faupel.
The beta non-invasive cervical cancer detection device is made up of components expected to be used in production units. The beta single-patient-use disposables are made of molded plastic and contain the calibration material expected to be used in the final commercial product.
The non-invasive cervical cancer detection device uses proprietary technology to identify cancers and precancers painlessly and non-invasively by analyzing light reflected from the cervix. The device creates an image of the cervix that highlights the location and severity of disease. 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. To date, more than 1,600 women have been tested with prototypes of the non-invasive cervical cancer detection device. Research and commercialization of the product are being funded in part by grants from the National Cancer Institute.
According to published reports, cervical cancer is the third most common cancer among women worldwide. Worldwide, there are approximately 471,000 cases of cervical cancer diagnosed annually and approximately 233,000 deaths per year. Approximately 60 million Pap tests are performed annually in the United States. The company estimates the annual global market potential for a non-invasive cervical cancer test to be over $1.3 billion.
About Guided Therapeutics, Inc.
Guided Therapeutics, Inc. is a subsidiary company of SpectRx, Inc. Guided Therapeutics is developing and plans to bring to market the non-invasive cancer detection technology. SpectRx intends to separately finance Guided Therapeutics. For more information, visit www.guidedtherapeutics.com.
About SpectRx, Inc.
SpectRx, Inc. (OTCBB: SPRX) is a diabetes management company developing and providing innovative solutions for insulin delivery and glucose monitoring. SpectRx markets the SimpleChoice(R) line of innovative diabetes management products, which include insulin pump disposable supplies. SpectRx also plans to develop a consumer device for continuous glucose monitoring. For more information, visit www.spectrx.com.
The Guided Therapeutics 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 SpectRx's 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 in SpectRx's reports under the heading "Risk Factors" filed with the SEC, including SpectRx's Annual Report on Form 10-K for the fiscal year ended December 31, 2004 and subsequent quarterly reports.
