Study to assess fluorescence visualization technology impact on oral cancer surgery efficacy
BURNABY, British Columbia, June 6, 2011 — LED Dental Inc. announced today that its VELscope Vx Enhanced Oral Assessment system will be utilized in a large scale University of British Columbia (UBC) clinical trial designed to document the ability of tissue fluorescence visualization (FV) technology to increase the efficacy of surgery to remove oral cancers.
Internationally recognized for its work in applying FV technology in the lungs, cervix, skin, and oral cavity, UBC has shown that FV devices can identify both occult and clinically visible premalignant and malignant lesions. In a recent, small scale, retrospective study, UBC researchers documented that FV helped surgeons determine the extent of the high-risk FV field surrounding the oral cancer and achieve remarkably lower two-year recurrence rates (0% for FV-guided surgery vs. 25% for those without the FV-guided approach). The upcoming study reflects the need for a larger scale prospective, randomized controlled (Phase III) trial to gather strong evidence of the efficacy of FV-guided surgery.
The three objectives of the study are to assess the ability of FV-guided surgery to: (1) reduce the recurrence rate of the cancer; (2) cost-effectively improve the quality of life of oral cancer patients; and (3) spare healthy tissue while increasing the capture of high-risk tissue.
The official title of the study is, “Efficacy of Optically-guided Surgery in the Management of Early-Staged Oral Cancer.” The study will involve 200 patients diagnosed with severe dysplasia, carcinoma in situ, or invasive squamous cell carcinoma; 100 will have FV-guided surgery, and 100 will have surgery that is not FV-guided. In addition to UBC, more than 10 other universities, hospitals, and institutions throughout Canada will be involved in the study. The study is expected to be completed in June 2015.
LED’s VELscope device pioneered the application of FV technology to the oral cavity. It is the first adjunctive device cleared by the FDA and Health Canada to help detect cancerous and precancerous oral lesions that might not be apparent to the naked eye, and to help determine the appropriate surgical margin when excision is warranted.
Since the 2006 launch of the first generation model, more than 6,000 VELscope systems have been sold and used to conduct more than 10 million oral cancer exams. The latest generation of this technology, the VELscope Vx, features a highly convenient cordless design and a price less than half that of prior models. VELscope exams take only two minutes, can be given as part of the patient’s regular hygiene check-up, are affordable for patients, and involve no rinses, dyes, or discomfort.
The VELscope Vx is distributed exclusively in North America by Henry Schein Dental.
LED Dental Inc. is a wholly-owned subsidiary of LED Medical Diagnostics Inc., which was founded in 2003 and is headquartered in Burnaby, British Columbia, Canada. For more information, call +1 (604) 434-4614, or visit www.VELscope.com.
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The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Certain information included in this press release (as well as information included in oral statements or other written statements made or to be made by the company) contains statements that are forward-looking, such as statements relating to anticipated future revenues of the company and success of current product offerings. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future and, accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of the company. For a description of additional risks and uncertainties, please refer to the company’s filings with the Securities and Exchange Commission.
