LED Dental Inc. Receives FDA 510(k) Clearance for its VELscope® Oral Mucosal Examination Device

LED Dental Inc. Receives FDA 510(k) Clearance for

its VELscope^® Oral Mucosal Examination Device

VELscope Enables Dental Professionals to Detect Abnormal Tissue in its

British Columbia, Canada – May 18, 2006 – LED Dental Inc., a Vancouver-based medical device company, announced today that it has been granted FDA 510(k) clearance to market its Visually Enhanced Lesion Scope – or VELscope^® – oral mucosal examination device.

“We are extremely pleased that the FDA has made such a swift determination on VELscope – a device that we firmly believe will help dentists, hygienists and other oral healthcare providers save countless lives by identifying oral mucosal abnormalities that are or may lead to oral cancer,” said LED Dental Inc. president, Wayne Rees.

The VELscope system consists of a light source and direct viewing handpiece that will be used during oral cancer and mucosal screenings as part of routine dental hygiene visits on all adult patients. Specifically, VELscope is an adjunctive screening device that utilizes a narrow band of high-energy blue light and specialized filter technology to help evaluate oral mucosa for abnormal areas of concern, such as potentially cancerous lesions that can be undetectable under white light.

VELscope’s Direct Optical Fluorescence Visualization Technology was proven effective in clinical trials conducted by the British Columbia Cancer Agency (BCCA) and financed in part by over $50 million in grants from the National Institute of Dental and Craniofacial Research, part of the National Institutes of Health, a U.S. government-funded agency.

“VELscope’s improved real-time visual detection capability is poised to enhance the overall efficacy of oral screening programs, which enables the treatment of cancerous lesions earlier in the disease process,” explains Rees. “This is significant because 50% of patients diagnosed with oral cancer are expected to die within 5 years.¹ But if caught early, 90% of oral cancer cases are survivable.”²

The American Cancer Society estimates that there will be nearly 31,000 new cases of oral cancer in the U.S. in 2006.³ It is also estimated that oral cancer kills one American every hour, 24 hours a day.⁴

Early screening, diagnosis and treatment for oral cancer can save lives. VELscope in particular can play a large part because it is simple, noninvasive, easy to incorporate into routine hygiene exams and is complementary with other treatments.

“VELscope is a safe, noninvasive and easy-to-use device that will enable dental professionals to become the true gatekeepers of oral health,” said Dr. Scott Benjamin, a prominent practicing dentist, author, lecturer and clinical director of LED Dental Inc. “During clinical testing, I have detected lesions, later proven by biopsy to be precancerous lesions, that were not apparent to the naked eye. The VELscope enabled the discovery, treatment, and management of the disease at an earlier stage than I could ever have hoped for in the past.”

VELscope will be ready to ship starting in late June and will be available through leading dental distributors such as Patterson, Sullivan-Schein, Benco and Burkhart. For more information call LED Dental Inc. at 1-604-541-4614 or visit www.velscope.com.

1. Silverman, Sol Jr., 2001. “Demographics and Occurrence of Oral and Pharyngeal Cancers: The Outcomes, the Trends, the Challenge.” JADA, vol.132 (November):7S-11S. [cited 28 January 2006]. Available from http://www.ada.org/prof/resources/pubs/jada/reports/suppl_oralcancer_03.pdf

4. National Institute of Dental & Craniofacial Research, “Oral Cancer – Confronting the Enemy,” Spectrum Series [Internet] National Institutes of Health, Bethesda, MD. [cited 28 January 2006]. Available from http://www.nidcr.nih.gov/HealthInformation/DiseasesAndConditions/SpectrumSeries/OralCancerEnemy.htm

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