FDA Medical Device Panel Recommends Market Clearance for SpectraSCIENCE's Virtual Biopsy System.MINNEAPOLIS--(BUSINESS WIRE)--Nov. 22, 1999-- SpectraSCIENCE, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :SPSI SPSI Seattle Psychoanalytic Society SPSI Static Placement, Static Issue ) announced today that the Gastroenterology gastroenterology Medical specialty dealing with digestion and the digestive system. In the 17th century Jan Baptista van Helmont conducted the first scientific studies in the field; William Beaumont published his own observations in 1833. and Urology urology Medical specialty dealing with the urinary system and male reproductive organs. It traces its origin to medieval lithologists, itinerant healers who specialized in surgical removal of bladder stones. Devices Panel of the Medical Devices Advisory Committee for the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. voted to recommend FDA clearance for the Company to market its Virtual Biopsy(TM) System for use in colonoscopy and flexible-sigmoidoscopy. The Virtual Biopsy(TM) System utilizes cool-laser light to perform an "optical biopsy" (without the need to physically remove tissue) to aid and improve the physician's accuracy in determining whether suspect tissue is normal, as opposed to potentially cancerous or cancerous. The Virtual Biopsy(TM) System provides an instant analysis that can be immediately communicated to the patient, eliminating the normal several day waiting period for pathology results from an excisional biopsy excisional biopsy A surgical procedure intended to completely remove–ie, excise a lesion submitted for pathological evaluation; in EBs, the nature of the lesion–ie benign vs malignant is often unknown at the time of operation, and thus the margin of . The approval recommendation came after a full day meeting of the Panel that was held on Friday, November 19th. All aspects of SpectraSCIENCE's PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy submission were discussed by the panel, which was composed of several physician specialists in Gastroenterology, Urology, and Surgery as well as non-voting representatives from Nursing and Industry. The recommendation included a mandated post-approval flexible-sigmoidoscopy study that the Company had already planned to conduct in anticipation of its internal marketing plans. A positive recommendation by an FDA Device Panel is usually followed within a few months by FDA clearance to market a device. Chet Sievert sie·vert n. Abbr. Sv A unit of ionizing radiation absorbed dose equivalent in the International System of Units, obtained as a product of the absorbed dose measure in grays and a dimensionless factor, stipulated by the International , President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. for SpectraSCIENCE, stated: "Everyone associated with SpectraSCIENCE is delighted that the Panel has recommended market clearance for our Virtual Biopsy(TM) System. The positive recommendation for market clearance by this judicious and discerning group is the culmination of almost two years of steadfast dedication and effort on the part of each SpectraSCIENCE employee, our clinical investigators and our medical and scientific advisors - many of whom formally participated in the panel meeting. The recommendation by the Panel represents their acceptance of the safety and effectiveness of our revolutionary approach to differentiating between normal tissue and abnormal tissue that may develop into colon cancer colon cancer, cancer of any part of the colon (often called the large intestine). Colon cancer is the second most common cancer diagnosed in the United States. ." Mr. Sievert added, "Colon cancer is the second leading cause of cancer deaths in the United States, indiscriminately killing 55,000 Americans annually without any regard for their race or sex. Two striking statistics for colon cancer are represented in the facts that it is the cause of more deaths in women over the age of 75 than death from breast cancer, and that 90 million Americans are considered to be 'at risk' for its development. We now look forward to the opportunity to market the Virtual Biopsy(TM) System to help in the fight against this deadly disease by establishing clinical utility for the Virtual Biopsy(TM) System among the approximately four million colon endoscopies performed in the United States every year." Based in Minneapolis, SpectraSCIENCE, Inc. (www.spectrascience.com) develops innovative Laser Induced Fluorescence systems capable of determining whether tissue is normal, as opposed to potentially cancerous or cancerous. The Virtual Biopsy(TM) System is SpectraSCIENCE's first fully developed product to incorporate its proprietary Laser Induced Fluorescence technology. SpectraScience believes that its Laser Induced Fluorescence technology for detection of cancer represents an enabling platform that may also be used to detect cancers of the prostate, cervix cervix /cer·vix/ (ser´viks) pl. cer´vices [L.] 1. neck. 2. the front portion of the neck. 3. cervix uteri. , bladder and the esophagus. A clinical investigation utilizing the technology in the esophagus is already underway by the company. This news release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. Additional risks that may affect the Company's future performance are detailed in Exhibit 99 to the Company's Quarterly Report on Form 10-QSB for the quarter ended March 31, 1999. |
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