VELscope System Called the World's Leading Oral Cancer Screening System

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LED Dental estimates that its VELscope Oral Cancer Screening System is used for more oral cancer examinations than any other device in the world. A total of 4,000 VELscope devices are in use worldwide, and a total of over 4 million exams have been given with the device since its introduction two and one-half years ago. The VELscope system was the first dental device to utilize tissue fluorescence visualization technology.

we have just scratched the surface of the VELscope system's potential.

LED Dental Inc. claimed today that its VELscope system is used for more oral cancer examinations than any other adjunctive technology in the world.

Impressive Milestones Passed
According to Dr. Ralph Green, president and CEO of LED Dental's parent, LED Medical Diagnostics, "Since our mid-2006 launch, we have sold over 4,000 VELscope systems worldwide. Based on an independent survey of VELscope users, we estimate that these devices have been used to conduct over 4 million VELscope exams to date." Dr. Green added, "What's more, we estimate that over 3 million additional VELscope exams will be conducted in 2009 alone. Based on sales information reported by our leading competitor, it is clear that their product is currently being used for a much lower number of exams."

Powerful Supporting Research
The tissue fluorescence visualization technology platform on which the VELscope system is based is the culmination of over $50 million in research funded by the National Institutes of Health and other respected institutions and conducted by such leading organizations as the British Columbia Cancer Agency and the University of Texas's M.D. Anderson Cancer Center. Translating this highly sophisticated, breakthrough technology for use in an efficacious device to examine the oral mucosa was the brainchild of LED Dental and the British Columbia Cancer Agency. Launched in 2006 as the first tissue fluorescence device made commercially available to the dental community, the VELscope system revolutionized the dental practitioner's ability to visualize the oral mucosal environment. A second-generation device featuring a more powerful lamp and several other advancements was introduced in 2008. The VELscope system remains the first and only device in widespread use that is cleared by the FDA and Health Canada to help dental practitioners discover tissue changes, including dysplasia and cancer, that might not be apparent to the naked eye, and to help surgeons determine the appropriate surgical margin when excising cancerous lesions.

The VELscope system's regulatory clearances were based in part on three clinical studies conducted by researchers at the British Columbia Cancer Agency.  The first, "Simple Device for the Direct Visualization of Oral Cavity Fluorescence," was published in the Journal of Biomedical Optics in 2006.  The second, "Fluorescence Visualization Detection of Field Alterations in Tumor Margins of Oral Cancer Patients," was published in the prestigious Clinical Cancer Research journal in 2006.  The third, "Direct Fluorescence Visualization of Clinically Occult High-Risk Oral Premalignant Disease Using a Simple Hand-Held Device," was published in the equally prestigious Head & Neck journal in early 2007.

Since these original publications, the clinical research community has continued to show intense interest in clinical application of the VELscope fluorescence visualization system and its role in oral disease and oral cancer management.  The British Columbia Cancer Agency has presented very exciting results on the performance of VELscope's fluorescence visualization technology in helping detect oral cancer and pre-cancer as part of a longitudinal study involving over 500 dysplasia patients.  They also remain very strong proponents of the technology as a tool to help surgeons determine lesion margins and recently presented new data indicating that patients who underwent fluorescence-assisted lesion surgery have considerably fewer high risk lesions present at follow-up than a control group.   

In addition, extensive clinical studies of the VELscope system are currently underway at such respected institutions as the University of Washington, the University of Chicago, Ohio State University, the Baylor College of Dentistry, Kings College in London and the University of Cologne. Speaking about a recently completed but yet-to-be-published study at the University of Washington, Dr. Edmond Truelove, Chair of Oral Medicine at the university, disclosed to the New York Times that the VELscope system discovered 100% of the cases of moderate-to-severe dysplasia, versus only 68% for a conventional visual exam.

Outstanding Clinical Experiences Reported by Dentists
"While we are quite proud of the milestones we have achieved," said Dr. Ralph Green, president and CEO of LED Dental's parent, LED Medical Diagnostics, "we have just scratched the surface of the VELscope system's potential." Dr. Green added, "We know from user surveys that the VELscope exam is easy to administer, takes only two to three minutes, and is financially attractive for the practice. What's more, patients find it very affordable and love the fact that no distasteful rinses or messy stains are required. Most important, clinicians are telling us that it's helping them discover abnormal tissue that they otherwise would have missed. When you look at these simple facts, there is absolutely no reason why every dental practice should not have a VELscope system."

Clinicians give the VELscope system high marks for the relative ease with which it can incorporated into dental practices. Said Dr. Green, "We believe that a big part of this is the fact that dentists can easily photo-document any suspect areas that need to be referred to a specialist for further observation and possible surgical biopsy." In fact, the latest generation of the VELscope system comes with an adapter kit that makes it easy for the clinician to attach a digital camera to the VELscope hand-piece. No existing competitive products, including a new low-powered device now being introduced to the market, have this capability.

Dental Practices: The First Line of Defense
One hundred Americans develop oral cancer every day, and one American dies of the disease every hour of every day. Despite the fact that tobacco usage is declining, the rate of occurrence of oral cancer is actually increasing. This increase is widely attributed in large part to the spread of HPV-16, a strain of the sexually transmitted human papilloma virus strongly associated with oropharyngeal cancers. This has led many health experts to recommend that anyone old enough to have sex should receive an oral cancer exam at least once a year.

The need for regular exams is further supported by studies showing that the majority of oral cancers are discovered in late stages, when the five-year survival rate is 20-to-30%. When discovered in early stages, however, the survival rate leaps to 80-to-90%.

In the words of Brian Hill, founder of the widely-respected Oral Cancer Foundation, "Simply stated, early detection is the key to higher survival rates. And the only way that can possibly happen is if dental practices step up and start making opportunistic, comprehensive oral cancer exams a mandatory part of their annual and even semi-annual exams." According to Mr. Hill, "The most essential step is a visual and tactile exam. When this exam is augmented by an adjunctive exam utilizing tissue fluorescence visualization, the opportunity for early discovery is increased. The conventional and adjunctive exams combined should take only six minutes or so, which is little to ask when you consider the potentially life-saving benefit provided to the patient."

About LED Dental
LED Dental Inc. is a wholly-owned subsidiary of LED Medical Diagnostics Inc., which was founded in 2003 and is headquartered in White Rock, British Columbia, Canada. For more information, call +1 604 541-4614, or visit http://www.VELscope.com.

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John Pohl
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