SAN DIEGO, March 23 /PRNewswire-FirstCall/ -- SpectraScience, Inc. (OTC Bulletin Board: SCIE), a San Diego based medical device company, announced today that the U.S. Food and Drug Administration has conducted an unannounced inspection of its facility. No Form 483 was issued and the Company remains in compliance with all regulations.
Jim Hitchin the Company’s CEO said, “The inspection is part of an ongoing review of our Class III facility where we manufacture our patented and proprietary WavSTAT® Optical Biopsy System and LUMA® Cervical Imaging System. Both systems are used by physicians as an adjunctive tool to assist in determining if tissue is normal, pre-cancerous, or cancerous within seconds. The WavSTAT System is currently approved by the FDA for use in the colon. A new application for detecting pre-cancers in the throat, sometimes called Barrett’s esophagus, is being tested in clinical trials. Cancer of the esophagus is more than 90% fatal and may develop as a result of chronic heartburn or GERD. Esophageal cancer is growing six times faster than all other cancers.
“This is our second unannounced inspection in two years. No adverse observations were made in either visit. I believe this is an excellent indicator of the quality system we have developed and the standards we hold ourselves to in manufacturing our products.”
SpectraScience holds approximately 60 patents worldwide that have been issued or are pending on its WavSTAT Optical Biopsy System and LUMA Cervical Imaging Systems.
Forward-Looking Statements
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, it’s 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 provide 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 imaging technology has received FDA approval for a non-invasive optical system that is proven to more effectively detect cervical cancer precursors than conventional methods available in the market today.
Contact:
SpectraScience, Inc. Jim Hitchin, Chief Executive Officer (858) 847-0200 x201 Hayden Communications Investor Relations Todd Pitcher 858)-518-1387 SOURCE SpectraScience, Inc.
