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Zila & Experts Testify at Congressional Hearing on Innovative Technology for Veterans; Urge Broader Use of ViziLite(R) Plus by VA for Oral Cancer Screening

Posted on: Wednesday, 13 May 2009, 10:53 CDT

SCOTTSDALE, Ariz., May 13 /PRNewswire-FirstCall/ -- At a congressional hearing today in Washington, DC, legislators were urged to press the U.S. Department of Veterans Affairs to immediately expand use of ViziLite(R) Plus, the FDA-cleared technology for the early detection of oral abnormalities that could lead to cancer. David Bethune, chairman and CEO of Zila, Inc. (Nasdaq: ZILA), developer and marketer of ViziLite Plus, addressed the issue in testimony before the House Committee on Veterans' Affairs. He was joined by Drs. David Sidransky, William Balanoff and Joel Epstein, experts on oral oncology and oral cancer diagnostics.

Noting that Veterans are at dramatically higher risk for oral cancer, due to their higher rates of smoking, chewing tobacco and drinking, Bethune said the VA should "immediately implement annual ViziLite Plus oral cancer screening of all Veterans who are seen at VA facilities nationwide. This is the best way to assure the consistent delivery of quality life-saving care to our Veterans."

Oral cancer kills one American every hour, but Veterans are 2.8 times more likely to get oral cancer than the general public. The conventional exam for oral cancer, in which dentists use only their unaided eyes and fingertips, has been shown in some studies to miss up to a third of serious lesions. Supplementing the exam with ViziLite Plus has been shown to produce 100% screening effectiveness.

"The VA currently diagnoses roughly five percent of all the nation's oral cancers," Bethune noted, "but 70 percent of the time the cancer is at late stage, when the five-year survival rate is just 26 percent. The key to survival is early detection and, even better, detection of pre-cancerous tissue. Dentists across America and around the world are dramatically improving the quality of oral cancer exams with ViziLite Plus, which is covered by many insurance companies. Even inmates in many federal prisons have access to this technology. It's not right that our Veterans, who have put their lives on the line for this nation, should be denied this effective, proven, scientifically sound healthcare technology."

Zila has contracted to provide ViziLite Plus to the VA at a steep discount. Bethune said individual VA facilities have "dragged their heels" on performing the three-minute, painless ViziLite exam, citing false issues like cost or inconvenience. He told the congressional panel that screening all 5.5 million Veterans who access VA facilities yearly would cost about $60 million, "a sum that would be easily recouped by the reduction in surgeries, long-term care, suffering and death." Bethune pointed to a Delta Dental analysis showing that treatment of late stage oral cancer typically exceeds $200,000 per patient, while treatment of pre-cancerous lesions costs only $500 - $1,500. "For patients, early detection means a faster return to the workplace, which reduces lost wages and improves productivity," he observed.

Also testifying today was Dr. David Sidransky, Director of the Head and Neck Cancer Research Division at Johns Hopkins University School of Medicine and Professor of Oncology, Otolaryngology-Head and Neck Surgery, and Cellular & Molecular Medicine at Johns Hopkins University and Hospital. He is one of the world's most cited cancer researchers, and author of over 340 peer-reviewed publications.

Dr. Sidransky told the committee that worldwide research shows that visual examination by untrained examiners often misses the earliest, more curable lesions. "By contrast, published studies reporting sensitivity values for ViziLite are consistent. To date, the sensitivity of ViziLite examination in identifying dysplasia and cancer is reported as 100%." Beside ViziLite Plus, he continued, "No other medical device has sufficient sensitivity and specificity to meet the requirement of early detection in oral cancer among Veterans. Other dyes and devices cannot precisely identify precancerous lesions and early invasive cancers while excluding healthy patients who need no further intervention. Indeed, ease of use makes ViziLite appropriate for use by all oral disease health care professionals including dentists, periodontists, oral surgeons, otolaryngologists and primary-care physicians.

Dr. Sidransky concluded, "ViziLite Plus is easy to use, sensitive and specific. In an aging patient population, this product can bring diagnostic power to physicians outside the dental specialties, for greater value and potentially more savings in hospitalization. Inclusion in VA oral cancer screening protocols would improve screening efficacy for lesions suspicious for precancer and cancer, and ultimately reduce the morbidity and mortality of this disease."

Two additional dental authorities were present and filed statements with the committee.

Dr. Joel Epstein, DMD, Director, Interdisciplinary Program in Oral Cancer Biology, Prevention and Treatment at the University of Illinois College of Medicine, Chicago Cancer Center, noted that "health care providers have been and continue to be challenged with identifying abnormal oral conditions, which may represent premalignant and malignant disease. Until recently we have had to rely solely on visual examination. The result has been that the majority of oral cancer is not diagnosed until symptomatic and with advanced stage of disease, when extensive treatment is required and prognosis is guarded." Dr. Epstein added, "The Veteran population could be well-served [with ViziLite Plus] by reducing the number of false positive findings associated with visual examination, thus potentially reducing the number of unnecessary biopsies. This outcome has been shown in a multicenter study, in a risk population similar to the VA population, where a reduction in the number of biopsies by approximately half would have still identified clinically significant lesions."

Ft. Lauderdale, Florida, dentist and frequent dental lecturer William L. Balanoff, DDS, advised the committee that ViziLite Plus is technically a screening adjunct, like several other well-known technologies. "Cancer death rates from prostate, breast and cervical cancer did not begin to show substantive decreases until adjunctive screening technology allowed physicians to see or feel things they could not see or feel with their unaided eyes or hands. Mammograms, Pap smears and PSA tests have reduced death rates by 40%, 80% and 17% respectively," he said. Balanoff offered the congressmen a real world viewpoint: "For the past five years, the use of chemiluminescence (ViziLite) has allowed me to identify lesions that were otherwise missed during previous conventional oral examination. This device is now the standard of care, along with conventional visual examination, in my conduct of dentistry."

Mr. Bethune commented, "I am extremely pleased that Veterans' Affairs Committee chairman Bob Filner invited Zila to participate in this hearing, so that we could provide valuable information about ViziLite Plus and its importance to our Veterans."

Zila markets ViziLite Plus throughout the U.S., as well as in Puerto Rico and Canada. The product is available in the United Kingdom, Ireland, Germany, Spain, Portugal, France and Greece. The company has formed distribution agreements in other international markets, including Russia and Belarus, where product registration is in process. These markets and others in the Pacific Rim region, especially China and India, will form the bulk of the company's continued global expansion for ViziLite Plus.

For more information about the company and its products, please visit www.zila.com. Photos can be downloaded at http://vizilite.com/download/

About Oral Cancer and ViziLite Plus

Oral cancer is the sixth most common type of cancer worldwide and in the U.S., one person dies every hour from the disease. 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, yet prior to the introduction of ViziLite Plus the only screening tools available were the manual and visual exam, which helps explain why the mortality and morbidity associated with oral cancer have not markedly improved in the past 40 years. ViziLite Plus utilizes a chemiluminescent light source (ViziLite) and a patented vital tissue dye (TBlue), helping dentists and dental technicians identify and evaluate abnormalities in the mouth that could potentially harbor pathologic changes. The ViziLite Plus exam takes only minutes and is totally painless and non-invasive.

Oral Cancer Risk factors:

-- age - adults

-- tobacco use - particularly if combined with heavy alcohol consumption

-- heavy alcohol consumption

-- excessive sun exposure to the lips

-- sexually transmitted virus exposure (HPV)

A report in the New England Journal of Medicine suggests that exposure to sexually transmitted human papillomavirus number 16 (HPV16) causes oropharyngeal cancer (a type of oral cancer) and may help explain the increasing incidence of the disease in younger people.

About Zila, Inc.

Zila, Inc., headquartered in Scottsdale, Arizona, is a diagnostic company dedicated to the prevention, detection and treatment of oral cancer and periodontal disease. Zila manufactures and markets ViziLite(R) Plus with TBlue(R) ("ViziLite(R) Plus"), the company's flagship product for the early detection of oral abnormalities that could lead to cancer. ViziLite(R) Plus is an 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 Rotadent(R) Professional Powered Brush, the Pro-Select Platinum(R) ultrasonic scaler and a portfolio of oral pharmaceutical products for both in-office and home-care use. All of Zila's products are marketed and sold in the United States and Canada primarily through the company's direct field sales force and telemarketing organization. The company's products are marketed and sold in other international markets through the direct sales forces of third party distributors. Zila's marketing programs reach most U.S. dental offices.

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are based largely on Zila's expectations or forecasts of future events, can be affected by inaccurate assumptions and are subject to various business risks and known and unknown uncertainties, a number of which are beyond the Company's control. Therefore, actual results could differ materially from the forward-looking statements contained herein. A wide variety of factors could cause or contribute to such differences and could adversely affect revenue, profitability, cash flows and capital needs. There can be no assurance that the forward-looking statements contained in this press release will, in fact, transpire or prove to be accurate. For a more detailed description of these and other cautionary factors that may affect Zila's future results, please refer to Zila's Form 10-K for its fiscal year ended July 31, 2008 and Form 10-Q for the quarter ended January 31, 2009.

SOURCE Zila, Inc.

Source: PR Newswire

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