SAN DIEGO, Oct. 1 /PRNewswire-FirstCall/ -- SpectraScience, Inc. (OTC Bulletin Board: SCIE), a San Diego-based medical device company, today announced that it has shipped its non-invasive WavSTAT(R) Optical Biopsy System to the University of Southern California to demonstrate the clinical value of the Optical Biopsy System as an adjunctive tool to improve clinical sensitivity in identifying dysplasia or cancer in the esophagus. This marks the final phase of a study which has been conducted over the past three years.
Earlier this month, SpectraScience announced that it had delivered WavSTAT Systems to the Mayo Clinic and San Diego VA Hospital for similar studies. Other participants in the study include Minnesota Gastroenterology, P.A. and the Boston University VA Hospital.
Jim Hitchin, CEO of SpectraScience, commented, "We are pleased to be moving forward with our clinical study to demonstrate the value of the WavSTAT System in screening for esophageal cancers and pre-cancers, and believe that the System can be instrumental in helping doctors more reliably and efficiently detect pre-cancerous tissue at sufficiently early stages to provide more effective treatment."
The WavSTAT Optical Biopsy System was approved by the FDA in November of 2000 as safe and effective for adjunctive use during endoscopy of the colon to improve a physician's sensitivity to identify pre-cancerous polyps. The System also received the CE Mark in Europe in September 2007. The approved WavSTAT System uses a low power, non-significant risk laser to scan tissue and instantaneously help the physician determine whether small polyps are normal or pre-cancerous without physically removing the tissue. If polyps are determined to be pre-cancerous, they can be removed during the same procedure.
Current standards of care dictate that if a patient has severe chronic symptoms of heartburn, an endoscopy of the esophagus may be warranted and, if indicated, multiple physical biopsies are taken to check for pathology of dysplasia or cancer. During endoscopic examination, diseased tissue is not always visually apparent, especially at the pre-malignant stages. As a result, physicians take physical biopsies at visually suspicious areas, oftentimes randomly, in an effort to find diseased tissue.
The clinical use of the WavSTAT System to improve the endoscopist's clinical sensitivity in identifying dysplasia or cancer in the esophagus will be evaluated. The hypothesis that the sensitivity of a WavSTAT-assisted endoscopic examination improves that of standard endoscopy alone will be tested. If this hypothesis is correct, the physician should be able to take fewer physical biopsies, decrease the duration of the exam and minimize discomfort of the patient.
Acid reflux, or heartburn, is a common ailment experienced by almost all adults at some point in their lives. As many as 44% of adults in the United States report having heartburn at least once a month; 14% report having it weekly and 7% experience it daily. If heartburn occurs often, or other symptoms such as difficulty swallowing or weight loss develop, a diagnosis of gastro-esophageal reflux disease (GERD) is considered. It is reported that approximately 50 million Americans have GERD symptoms. In most cases, GERD is benign, however, when GERD symptoms are frequent or chronic, a patient should be considered as a candidate to receive an endoscopy of the esophagus.
Barrett's esophagus is a disease of the lower esophagus thought to be caused primarily by GERD. Approximately 10-20% of GERD patients are believed to have Barrett's esophagus. In Barrett's, the lining of the esophagus changes to a type of tissue similar to that sometimes found in the small intestine called intestinal metaplasia. Currently, Barrett's can only be confirmed by examination of tissue biopsies obtained during an endoscopy of the esophagus.
Because the diagnosis of dysplasia has such a crucial impact on disease management and subsequent patient outcomes, a system that can aid in differentiating between suspect esophageal tissue with dysplasia or without dysplasia in real-time would have great clinical utility.
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 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(R) Cervical Imaging System has
received FDA approval as an optical non-invasive system that is proven to
more effectively detect cervical cancer precursors than conventional
methods currently available.
Jim Hitchin, Chief Executive Officer
(858) 847-0200 x 201
|SOURCE SpectraScience, Inc.|
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