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Major Study Supports Use of VELscope® Vx Technology for Detection of Oral Cancer and Pre-Cancer

  • May 07, 2013
  • News Releases

BURNABY, British Columbia – May 7, 2013– LED Medical Diagnostics Inc. (“LED Medical”, “the Company”), 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 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 COE 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.

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