Healthcare Industry News: Optical Biopsy System
News Release - September 16, 2009
SpectraScience Receives FDA Approval for Enhancements to WavSTAT(R) Optical Biopsy SystemSAN DIEGO, Sept. 16 (Healthcare Sales & Marketing Network) -- SpectraScience, Inc. (OTC Bulletin Board: SCIE ), a San Diego based medical device company, today announced that its application for premarket approval (PMA) relating to key enhancements of its WavSTAT platform technology has been approved by the Food and Drug Administration. The Company can now begin commercial distribution of the enhanced WavSTAT technology.
Jim Hitchin, SpectraScience's' CEO said, "We are pleased to now be able to bring to market the most up-to-date, leading edge technology for use in cancer screening. The enhancements we have made to the WavSTAT will make it easier for physicians to use and will provide an even greater level of critical data in a screening environment."
SpectraScience has filed for 60 patents worldwide on its WavSTAT Optical Biopsy and LUMAŽ Cervical Cancer Imaging Systems that are used to diagnose tissue to determine within seconds if it is normal, pre-cancerous, or cancerous. The WavSTAT and LUMA Systems are currently approved by the FDA for detecting pre-cancer and cancer in the colon and cervix, and an evaluation for detection of pre-cancers in the throat ("Barrett's esophagus") is being tested.
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements involve risks and uncertainties that may cause SpectraScience's actual results to differ materially from results discussed in forward-looking statements. Readers are urged to carefully review and consider the various disclosures made by SpectraScience in this news release, its most recent Form 10-K and in SpectraScience's other reports filed with the Securities and Exchange Commission ("SEC") that attempt to advise interested parties of the risks and factors that may affect SpectraScience's business. These forward- looking statements are qualified in their entirety by the cautions and risk factors filed by SpectraScience in its annual report on Form 10-K and other documents.
About SpectraScience, Inc.
SpectraScience is a San Diego based medical device company that designs, develops, manufactures and markets spectrophotometry systems capable of determining whether tissue is normal, pre-cancerous or cancerous without physically removing tissue from the body. The WavSTAT Optical Biopsy System uses light to optically scan tissue and provides the physician with an immediate analysis. With FDA approval for sale in the U.S. and the CE Mark for the European Union, the WavSTAT System is the first commercially available product that incorporates this innovative technology for clinical use. In addition, the Company's LUMAŽ Cervical Imaging technology has received FDA approval as an optical non-invasive system that is proven to more effectively detect cervical cancer precursors than conventional methods available today.
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