Zila Receives FDA 510(k) Clearance for ViziLite Eyewear
April 22 2008 - 7:56AM
Business Wire
Zila, Inc. (NASDAQ:ZILA) today 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. For more information about the company and its products,
please visit www.zila.com.
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