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ZILA, INC. SEEKS FDA MARKETING APPROVAL FOR ORAL LESION DETECTION DEVICE

 ZILA, INC. SEEKS FDA MARKETING APPROVAL
 FOR ORAL LESION DETECTION DEVICE
 PHOENIX, Feb. 13 /PRNewswire/ -- Zila, Inc. (NASDAQ: ZILA) yesterday filed with the U.S. Food and Drug Administration (FDA) notification under section 510(k) of the Food, Drug and Cosmetic Act of its intent to market Zila's Orascan(tm) oral lesion diagnostic aid.
 Zila is requesting FDA clearance to market the device, which is designed to improve visibility of oral lesions (including those caused by cancer) during clinical examination, promoting early detection and treatment. The request to FDA seeks the agency's concurrence that Zila's Orascan(tm) is a "medical device" within the meaning of the Medical Devices Amendment of 1976, and is safe and effective for its intended use.
 Zila President Joseph Hines said: "We hope that Orascan will become a primary tool to facilitate the early identification of high risk lesions by dentists and physicians. By focusing the health professional's attention on high risk sites, Orascan can play a major role in reducing the mortality rate and extraordinary human and monetary cost of oral cancer."
 For 1991, nearly 31,000 cases of cancer of the oral cavity and pharynx were expected to be diagnosed in the United States, with 21,400 cases specific to the oral cavity. For the year, 4,350 deaths resulting from oral cavity cancer were anticipated. Survival from oral cavity cancer is poor, with an average 5-year survival rate of 59.4 percent (37.6 percent among blacks).
 The U.S. Centers for Disease Control and National Institutes of Health report that "the earlier the detection of (such) cancers... the better the treatment options, making chances of survival greater." The 5-year survival rate for those diagnosed with localized disease is 75 percent, compared to 18 percent in those with distant metastasis at the time of diagnosis. The U.S. Prevention Services Task Force advises that "it may be prudent for clinicians to perform careful examinations of the oral cavity in patients who use tobacco or excessive amounts of alcohol, as well as those with suspicious symptoms of lesions which are detected through self- examination.
 "Orascan represents a significant step in Zila's growth as a producer of products important to the practice of medicine and to the quality of patient life," said Hines.
 Zila markets a growing line of non-prescription oral health care products including Zilactin(R), ZilaDent(tm) and Zilactol(tm). A large body of published independent clinical research on Zila technologies and extensive interaction by the company with dentists and pharmacists has produced strong support for the company's products.
 -0- 2/13/92
 /CONTACT: Joseph Hines of Zila, Inc., 602-266-6700/
 (ZILA) CO: Zila, Inc. ST: Arizona IN: MTC SU: PDT


DS -- DC008 -- 9559 02/13/92 08:46 EST
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Date:Feb 13, 1992
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