Joanna Lauck, RDH, in the Greenwood, Indiana, office of Dr. Jeffrey Golder, had a 32-year-old female patient with no tobacco or alcohol use. “On visual examination, the soft tissues appeared healthy. Using ViziLite Plus, however, we observed a small 3mm glow in the right buccal vestibule (the lower cheek). We did the TBlue sequence, which produced a positive stain. We referred the patient to the oral surgeon, who delayed doing a biopsy as the spot was so small. Six months later, biopsy confirmed dysplasia. We’d found a premalignancy. It was satisfying to know that we had made a difference.”
David L. Clemens, of Wisconsin Dells, Wisconsin, treated a 59-year-old female patient who was a smoker and casual drinker. “While she complained about cheek soreness related to her denture, ViziLite Plus drew our attention to a white area under her tongue that had not been visible with unaided vision. With TBlue, the area retained a deep, dark stain with distinct margins. Biopsy evidenced severe epithelial dysplasia. Upon learning of this pre-malignancy, the patient quit smoking. In my 28 years of practice, I have always done visual exams. Today I feel much more secure that my exams will find precancerous lesions, and, as seen in this case, maybe save someone's life.”
James Elias, DMD, of Louisville, Kentucky, had a male patient, 31, in good health with no tobacco or heavy drinking history. “Before this case, I had never seen the words Squamous Cell Carcinoma written anywhere other than in textbooks and journals. On first examination of this patient, all tissues appeared normal on visual inspection. Using ViziLite Plus, however, I clearly saw five islands of white tissue on the tongue. I applied TBlue and those areas retained the stain. Biopsy confirmed an early stage malignancy. The patient lost a small part of his tongue and a few lymph nodes, but early detection spared him major neck surgery. It was quite surprising to find cancer in so young a person. The experience made a strong impression on everyone at Mortenson Family Dental, changing the risk of oral cancer from an abstract idea to an immediate concern. It has made it easier for us to convince patients to undergo annual screenings.”
A male, 55, with no tobacco or alcohol use, proved a startling case study for Dr. Robert Marolt of White Bear Lake, Minnesota, and for his oral surgeon. “While no lesions were clinically visible, using ViziLite Plus I detected lesions on the right lateral border of the tongue. I referred the patient to our oral surgeon, who later wrote me a remarkable letter. It said, in part, ‘Clinically I could barely see any lesions on the tongue. I performed the biopsy from the ViziLite [with TBlue staining] photos that you sent. I was surprised that the pathology report showed this was pre-malignant epithelial dysplasia, as typically such dysplasia can be seen very well clinically. I was quite impressed with the ViziLite system.’” As Dr. Marolt put it so well in the brochure, “I believe it is incumbent upon all of us as dentists to be the first line of defense against oral cancer. I’ve made it a mission of mine not to have any of my patients die from oral cancer. Using ViziLite plus, we have seen two pre-malignancies so far, and we are alert for more, in younger as well as in older patients.”
ViziLite Plus with TBlue, 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.
About Oral Cancer and ViziLite Plus with TBlue
Oral cancer is the sixth leading cause of cancer worldwide, 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, an oral screening technology that utilizes a chemiluminescent light source (ViziLite) and a patented pharmaceutical-
Oral cancer risk factors include:
-- age - all adults
-- gender - more men than women develop oral cancer
-- smoking - particularly if combined with heavy alcohol consumption
-- chewing tobacco or using snuff
-- heavy alcohol consumption - particularly if combined with smoking
-- excessive sun exposure to the lips.
A recent report in the New England Journal of Medicine suggests that exposure to the 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. is a fully integrated oral diagnostic company dedicated to the prevention, detection and treatment of oral cancer and periodontal disease. ViziLite® Plus with TBlue®, 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 Rotadent® Professional Powered Brush, the Pro-Select Platinum® ultrasonic scaler and a portfolio of oral pharmaceutical products for both in-office and home-care use.
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, 2007 and Form 10-Q for the quarter ended April 30, 2008.
For more information about the company and its products, please visit www.zila.com.