SAN DIEGO, March 3 /PRNewswire-FirstCall/ -- SpectraScience, Inc. , a medical device company, announced today that the U.S. Food and Drug Administration has given approval to manufacture its LUMA(R) Cervical Cancer Imaging System in its San Diego facility. The LUMA Cervical Imaging System was developed to significantly improve the detection of high-grade pre-cancerous cervical abnormalities that have the potential to become invasive cancer.
Almost a thousand women die every day worldwide from cervical cancer. It is estimated that pre-cancerous cervical disease goes undiagnosed in about 200,000 American women each year. The LUMA System provides a safe, non-invasive and effective method, that when used as an adjunct to colposcopy, has been demonstrated to uncover at least 26% more high-grade precancerous disease than colposcopy alone.
SpectraScience CEO Jim Hitchin commented, “This approval is key for us to begin manufacturing the LUMA Systems here in our San Diego facility. This milestone provides FDA validation of our manufacturing expertise and removes production capacity constraints related to the marketing of the LUMA System as an important tool in the early detection of cervical cancer.”
SpectraScience has filed for 60 patents worldwide on its WavSTAT(R) Optical Biopsy and LUMA 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-KSB 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. The Company’s LUMA(R) 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.
CONTACT: Jim Hitchin, Chief Executive Officer of SpectraScience, Inc.,
+1-858-847-0200, ext. 201; or investor relations, Todd Pitcher of Hayden
Communications, +1-858-518-1387, for SpectraScience, Inc.
Web site: http://www.spectrascience.com/
