PORTOLA VALLEY, CA /PRNewswire/ -- Spectros announced that the T-Stat Tissue Oximeter sensor line will be expanded to include the new Continuum Cerebral Sensor line upon receipt of FDA marketing approval, anticipated in 2010.
The T-Stat continuum sensor relies on broadband, multispectral visible and IR illumination to obtain market-leading absolute tissue oximetry noninvasively in tissues such as the brain, gut, and breast. An FDA review process for marketing approval is underway, and Spectros anticipates marketing the Continuum sensor upon receipt of FDA marketing approval. Clinical studies of the Continuum sensor were initiated in 2008, with additional studies planned and in progress.
"The expansion of the T-Stat product line to include cerebral sensors furthers the already market-leading accuracy and success of the T-Stat into cerebral oximetry monitoring," notes Elizabeth van Thillo, Director of Marketing. "We currently have additional clinical studies at multiple clinical centers and will continue to demonstrate the efficacy of the T-Stat with the Continuum sensor line to reduce hospitalization costs and improve patient outcome in high-risk populations with early diagnosis."
Spectros markets advanced molecular-sensing and -imaging devices that shed light on ischemia and cancer. The company's champion product, the T-Stat VLS Tissue Oximeter, is the "first medical device FDA-approved as sensitive to ischemia," an insufficient supply of oxygen to tissue. T-Stat is the "only commercially available tissue oximeter that uses state-of-the-art multispectral visible light spectroscopy (VLS) technology." The noninvasive T-Stat VLS system is used clinically to provide a continuous and real-time absolute value, using 260 wavelengths, over the competing NIRS oximeter product lines that only use 2-4.
Spectros also develops molecular diagnostic tools for breast and prostate cancer, currently in phase I/II clinical trials, supported by the National Cancer Institute. Spectros is a venture-supported private concern and markets its products in the U.S. and internationally. T-Stat competes in the oximetry marketplace with devices from Somanetics and CAS Medical.