LED Medical Diagnostics Inc.

LED Medical Diagnostics Inc.

May 07, 2013 10:00 ET

LED Medical Diagnostics Inc.: Major Study Supports Use of VELscope® Vx Technology for Detection of Oral Cancer and Pre-Cancer

VELscope® Vx Screenings Increased the Detection of Cancerous and Pre-Cancerous Lesions by 62.5%

BURNABY, BRITISH COLUMBIA--(Marketwired - May 7, 2013) - LED Medical Diagnostics Inc. ("LED Medical", "the Company") (TSX VENTURE:LMD)(OTCQX:LEDIF)(FRANKFURT:LME), a developer of tissue visualization detection technologies for the medical industry, today cited a recent clinical study documenting the ability of its VELscope® Vx Enhanced Oral Assessment adjunctive technology to detect cancerous and pre-cancerous lesions that are missed by conventional exams.

Titled "Use of Fluorescent Light in Detecting Malignant and Premalignant Lesions in the Oral Cavity: A Prospective, Single-Blind Study" and originally published in the Journal of Otolaryngology-Head & Neck Surgery (June 2012), the study was conducted by Hani Z. Marzouki, MD, Thien Tuong Vi Vu, MD, FRCSC, Rania Ywakim, MD, Peter Chauvin, MD, FRCPC, James Hanley, PhD, and Karen M. Kost, MD, FRCSC of McGill University in Montreal, Canada. It involved 85 male and female patients considered to be at risk for oral cancer by virtue of a history of either smoking, alcohol use, or head and neck cancer. All patients were screened for oral cancer and pre-cancer in two ways: a conventional clinical examination, consisting of palpation of the face and neck to check for lumps and a naked eye inspection of the oral cavity to look for lesions; and an examination of the oral cavity using the company's VELscope® Vx Advanced Oral Screening System, which uses patented tissue fluorescence visualization technology to help detect abnormal oral tissue.

The combination of the conventional and VELscope® Vx exams detected 13 lesions that were biopsy-confirmed to be either malignant or pre-malignant. Importantly, 5 of these lesions were missed by the conventional exam but detected by the VELscope® Vx exam. Therefore, adding the VELscope® Vx exam to the screening process increased the number of cancerous or pre-cancerous lesions detected by 62.5 percent.

As a result, the study's author concluded, "Our data support the use of the VELscope® Vx device as a noninvasive, user-friendly screening tool and as an adjunct in identifying dysplastic lesions of the oral cavity in high-risk patients." They added, "This safe, non-invasive device may be particularly useful for dentists, family physicians, and general otolaryngologists as an adjunct in identifying malignant or dysplastic lesions of the oral cavity in high-risk patients."

"We have always strongly advocated that clinicians give all of their patients an annual conventional oral exam ("COE"), but this study is yet another indication of the importance of augmenting the COE with a 2 minute VELscope® Vx tissue fluorescence scan," said Peter Whitehead, founder and CEO of LED Medical Diagnostics and its subsidiary, LED Dental Inc., which manufactures the VELscope® Vx. "There are still many clinicians who feel they don't need an adjunctive screening device like the VELscope® Vx, but this and a number of other studies, as well as the real-world experience of thousands of VELscope® Vx users, strongly suggest that this is not true."

According to the Oral Cancer Foundation, the high death rate associated with oral cancer (43% mortality within five years) is not because it is hard to discover or diagnose, but due to the cancer being routinely discovered by dentists late in its development when it has already metastasized to other parts of the body, such as the lymph nodes of the neck. "A tissue fluorescence scan using a device such as the VELscope® Vx scope can help detect lesions that may be cancerous or pre-cancerous up to two years before they can be seen with the naked eye," continued Whitehead. "Oral cancer cannot be isolated to any particular age, race, gender or lifestyle choices, such as smoking or drinking; it can affect any one of us at any point in our lives. In addition, with the increased spread of the human papillomavirus ("HPV"), a confirmed cause of oral cancer, there are more and more cases of this disease being diagnosed among young people. In our view, all patients should receive an annual conventional oral exam accompanied by a tissue fluorescence scan as a part of their routine dental checkups. Both procedures take minutes to perform, add minimal cost to the checkup and can save lives by detecting oral cancer at an earlier stage."

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 by more than 13,000 dentists in 23 countries to conduct screenings for oral cancer, pre-cancer and other oral tissue abnormalities. 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.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contact Information

  • LED Medical Diagnostics Inc.
    Mark Komonoski, Investor Relations
    (403) 255-8483 or Toll-Free: (877) 255-8483
    Cell: (403) 470-8384
    Skype: mkomonoski