SpectraScience Corporate Update
06/30/2009
The Wall Street Transcript
05/05/2009
Des Moines Register Reports SpectraScience LUMA Enhances Cervical Cancer Exams
04/30/2009
Women’s Integrative Health Encinitas OB/GYN Selects LUMA Cervical Imaging System
03/09/2009
SpectraScience Receives FDA Clearance for Manufacturing Facility
03/03/2009
SpectraScience Inc.
SpectraScience has developed a technology platform to instantly determine if tissue is normal, pre-cancer or cancerous, without the need for exploratory biopsy. The system is indicated for use as an adjunct to lower gastrointestinal (GI) endoscopy and is intended for the evaluation of polyps less than 1 cm in diameter that the physician has not already elected to remove. The device is used in deciding which polyps should be removed and submitted for histological examination.The Company has received its first FDA approval to market its proprietary and patented optical biopsy system. The Company is also developing an additional application for the detection of pre-cancerous and cancerous tissue in the esophagus, as well as recently expanding product offerings to include cervical cancer and pre-cancer detection through the acquisition of Luma Imaging Corporation and its FDA approved LUMA® Cervical Imaging System.
The WavSTAT® Optical Biopsy System developed by SpectraScience is capable of determining whether tissue is normal, pre-cancerous or cancerous without physically removing tissue from the body and without waiting days for a pathology report. The WavSTAT uses a spectrophotometry technique known as Laser Induced Florescence (LIF). During LIF cool laser light shines onto and excites tissues to emit a returning florescent signal. The emitted florescence is collected, measured and analyzed by a proprietary software algorithm. This software algorithm provides the physician with an immediate analysis of the tissue. SpectraScience received US Food and Drug Administration (FDA) approval to market the WavSTAT system in November 2000. The product also carries the CE mark, a prerequisite for sales in the European Union.
The LUMA Cervical Imaging System was developed to significantly improve the detection of high-grade precancerous cervical abnormalities that have the potential of becoming invasive cancer. Based on data from the National ALTS study, it is estimated that about 200,000 women with precancerous disease go undiagnosed each year.
The LUMA System provides a safe and effective method, that when used as an adjunct to colposcopy, will find at least 26% more high-grade precancerous disease than the gold standard colposcopy in women with ASC and LSIL Pap tests.