Zila Receives FDA 510(k) Clearance For ViziLite Eyewear

Main Category: Dentistry
Also Included In: Regulatory Affairs / Drug Approvals;  Cancer / Oncology
Article Date: 24 Apr 2008 - 2:00 PDT

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Zila, Inc. (NASDAQ:ZILA) announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market ViziLite Eyewear. ViziLite Eyewear is reusable filtered eyewear to be worn by a health care professional to eliminate ambient light while performing an oral exam under chemiluminescence when a darkened room is not available.

"ViziLite Eyewear helps health care professionals administer ViziLite® Plus, our oral cancer screening product, in less than ideal lighting environments," said David Bethune, chairman and chief executive officer of Zila. "ViziLite Eyewear complements our product offering and will be marketed by the company's direct sales force."

ViziLite Eyewear only allows transmission of light necessary for a ViziLite examination while blocking interfering ambient light from the practitioner's field of view.

About Oral Cancer and ViziLite Plus

One American dies every hour of oral cancer and while tobacco and alcohol use are known risk factors, one quarter of all oral cancer cases occur in men and women with no risk behaviors. According to American Cancer Society data, nearly as many women will be diagnosed with oral cancer as with cervical cancer this year. The key to reducing the impact of this disease is early detection.

ViziLite Plus is an oral screening technology that utilizes a chemiluminescent light source (ViziLite) and a patented pharmaceutical-grade vital tissue dye (TBlue). The ViziLite Plus exam takes only minutes and is totally painless and non-invasive. Zila began marketing the product through its direct sales force in the U.S. in February 2007, in Canada in November 2007, and will launch ViziLite Plus in Europe in May 2008.

About Zila, Inc.

Zila, Inc. is a fully integrated oral diagnostic company dedicated to the prevention, detection and treatment of oral cancer and periodontal disease. ViziLite® Plus, the company's flagship product for the early detection of oral abnormalities that could lead to cancer, is the first and only adjunctive medical device cleared by the FDA for use in a population at increased risk for oral cancer. In addition, Zila designs, manufactures and markets a suite of proprietary products sold exclusively and directly to dental professionals for periodontal disease, including the Rota-dent® Professional Powered Brush, the Pro-Select® Platinum ultrasonic scaler and a portfolio of oral pharmaceutical products for both in-office and home-care use.

Zila, Inc.