SAN DIEGO, Sept. 16 /PRNewswire-FirstCall/ -- SpectraScience, Inc. , a San Diego-based medical devices company, today announced that it is shipping its WavSTAT(R) Optical Biopsy System to the Mayo Clinic and to the University of California San Diego/VA to complete a study at each site. The purpose of this study is to demonstrate the clinical value of the Optical Biopsy System as an adjunctive tool to improve an endoscopists’ clinical sensitivity in identifying dysplasia or cancer in the esophagus. This will be the final phase of the study which has been conducted over the past three years.
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 the endoscopist’s clinical sensitivity to identify pre-cancerous polyps. The system 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 they are pre-cancerous, they are 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 such as Barrett’s esophagus, dysplasia or cancer. During endoscopic examination, the diseased tissue is not always visually apparent, especially at the pre- malignant stages. Therefore, the endoscopist physically biopsies visually suspicious areas within and outside the Barrett’s area, areas with nodules or generally suspicious locations. The endoscopist also takes multiple representative samples by physical biopsy 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 proven, the physician should be able to take fewer physical biopsies, decrease the duration of the exam and minimize the discomfort of the patient.
Background
Acid reflux, or heartburn, is a common ailment known to 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, tissue damage 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, i.e., twice per week, or chronic, i.e., five-plus years, a patient should be considered as a candidate to receive an endoscopy of the esophagus to check for a condition called Barrett’s esophagus.
Barrett’s esophagus is a disease condition of the lower esophagus thought to be caused primarily by GERD. Approximately 10-20% of GERD patients are thought to have Barrett’s esophagus. Barrett’s is a condition in which the lining of the esophagus changes to a type of tissue similar to that normally found in the small intestine called intestinal metaplasia. Barrett’s can only be confirmed by histologic 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 the endoscopist 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 technology has received FDA approval for 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 x 201; or Investor Relations, Todd Pitcher of Hayden
Communications, +1-858-518-1387, for SpectraScience, Inc.
