BURNABY, BRITISH COLUMBIA--(Marketwired - Jun 10, 2013) - LED Medical Diagnostics Inc. ("LED Medical", "the Company") (TSX VENTURE:LMD)(LEDIF)(LME.F), a developer of tissue fluorescence visualization technologies for the medical industry, is pleased to announce that its patented VELscope® Vx oral examination device is currently involved in a Phase III study sponsored by the University of British Columbia in collaboration with the Terry Fox Research Institute and the British Columbia Cancer Agency.
The study, entitled 'Efficacy of Optically-guided Surgery in the Management of Early-staged Oral Cancer', postulates the hypothesis that fluorescence visualization ("FV") guided surgery will increase recurrence-free survival in oral cancer patients. Known internationally as a leading team in the application of tissue fluorescence technology, the University of British Columbia, in collaboration with the Terry Fox Research Institute, has shown that direct fluorescence visualization tools can effectively "identify clinically visible or occult premalignant and malignant lesions that are associated with lesions at risk with high-grade histology and high-risk molecular change. In a recent small scaled retrospective study, we have shown that FV helped surgeons in the operating room to determine the extent of the high-risk FV field surrounding the cancer and resulted in remarkably lower 2-year recurrence rates (0% for FV-guided vs. 25% for those without FV-guided approach). There is a need to design a larger scale prospective, randomized controlled (Phase III) trial to gather strong evidence in proving the surgery approach using this adjunctive tool."
The study is utilizing LED Medical's VELscope® Vx Enhanced Oral Assessment System, which centers on a hand-held scope that allows for direct visualization of tissue fluorescence in the oral cavity. "We have begun a longitudinal study to explore the effect of FV to define the surgical margin on the outcome of oral surgery." The study is currently ongoing.
"We continue to make great strides in the dental vertical for oral health assessment with the VELscope® Vx scope and there are now more than 13,000 dentists in 23 countries using it as part of their standard patient care," states founder and CEO, Peter Whitehead. "This particular study is unique in that it explores in a multi-centre design not only the efficacy of using the VELscope® Vx for lesion excision but also the resultant effect on long-term recurrence rates. VELscope® technology is the first tissue fluorescence technology to receive FDA and Health Canada clearance to assist surgeons in determining the appropriate surgical margin for the successful excision of oral cancer and pre-cancer. We are confident the study will further support its importance for this application."
About LED Medical Diagnostics Inc.
Founded in 2003 and headquartered in Burnaby, British Columbia, Canada, LED Medical Diagnostics Inc. is a leading developer of LED-based visualization technologies for the medical industry. The Company is currently listed on the Toronto Stock Exchange (TSX-V) under the symbol "LMD", the OTCQX under the symbol "LEDIF", as well as the Frankfurt Stock Exchange under the symbol "LME". For more information, visit www.ledmd.com.
Through its wholly-owned subsidiary, LED Dental Inc., the company manufactures the VELscope® Vx Enhanced Oral Assessment System, the first system in the world to apply tissue fluorescence visualization technology to the oral cavity. VELscope® Vx devices are now used to conduct more screenings for oral cancer and other oral tissue abnormalities than any other adjunctive device. For more information, visit www.leddental.com.
Forward Looking Information
This press release contains statements which, to the extent that they are not recitations of historical fact, may constitute forward-looking information under applicable Canadian securities legislation that involve risks and uncertainties. Such forward-looking information includes statements regarding the potential expansion of the Company's technology to other medical applications. Persons reading this press release are cautioned that such statements or information are only predictions, and that the Corporation's actual future results or performance may be materially different. Factors that could cause actual events or results to differ materially from those suggested by these forward-looking statements include, but are not limited to, product development risks such as regulatory, design, intellectual property, technological and competitor risk and the risk factors described in the Company's reports filed on SEDAR including its Annual Information Form and financial report for the year ended December 31, 2012. These and other factors should be considered carefully and readers should not place undue reliance on such forward-looking information. All forward-looking statements made in this press release are qualified by this cautionary statement and there can be no assurance that actual results or developments anticipated by the Company will be realized. The Company disclaims any intention or obligation to update or revise forward-looking information, whether as a result of new information, future events or otherwise, except as required by law.