ENHANCING DETECTION.... YOUR PRACTICE

Staggering Statistics on Oral Cancer 1 person dies from oral cancer each hour of every day The Mortality Rate for oral cancer has not decreased in over 30 years 72% of the cases of oral cancer are not diagnosed until stage two or later Late detection results in a five year survival rate of only 52% Cases of oral cancer are increasing at an alarming rate

Public Awareness of Oral Cancer Must Improve 41,350 new cases of oral cancer were discovered in 2013 Oral cancer impacted 3X as many people in 2013 when compared to cervical cancer (41,350 cases versus 12,340 cases respectively) HPV is increasing the number of oral cancer cases There has been a 60% increase in oral cancer in adults under the age of 40 (25% of these cases have no traditional risk factors (smoking, drinking, etc.)

New England Journal of Medicine, 2007 “Oral HPV infection is strongly associated with oropharyngeal cancer among subjects with or without the established risk factors of tobacco and alcohol use.”

Discovery & Intervention Potentially Malignant Disease Stages EARLY DETECTION IS THE KEY 67% of all oral cancer is currently discovered beyond this stage. (Stage II) Appropriate Stage for Discovery & Intervention Pre-cancerous epithelial lesions typically start below the surface of the tissue, at the basement membrane, and can remain unseen until they reach the surface. The most appropriate timing for discovery and intervention is during the earliest stages of dysplastic progression, before the disease has reached the surface. The VELscope helps identify of clinically unseen oral abnormalities. Early Dysplasia Moderate Dysplasia Severe Dysplasia Invasive Squamous Cell Carcinoma (SCC) Potentially Malignant Disease Stages Carcinoma-In-Situ (CIS)

VELscope VX – The Technology A safe blue light (no radiation) shines through the epithelial tissue and basement membrane to the stromal collagen Patented technology filters out everything except the fluorescence of the tissues Healthy tissue reflects back through the scope as a brilliant green color Suspicious tissue will absorb the light and not fluoresce, appearing extremely dark, almost black

Normal Floor of the Mouth

Obvious Dysplasia? A classic clinically occult lesion is seen here, as a well delineated dark area when viewed under VELscope. A biopsy from this area showed carcinoma in situ. Images courtesy of the British Columbia Oral Cancer Prevention Program

Fluorescence Visualization Carcinoma-In-Situ (CIS) Clinical Appearance (Visible White Light) This is a classic case study of which was published in the journal Head & Neck as an example of a so-called “clinically occult” lesion – that is, one that is virtually undetectable under conventional examination. The rather unremarkable appearance under white light is contrasted by the intense loss of fluorescence when viewed through the VELscope. This lesion was found to be carcinoma-in-situ upon biopsy. The toluidine staining of the lesion is also shown in bottom left photograph and is somewhat typical of the experience of the researchers and clinicians at the BC Cancer Agency in Vancouver, BC, Canada who use both tools clinically – the area showing loss of fluorescence is usually larger than the corresponding area that stains toluidine blue positive. Although there is not a global consensus on this, many experts believe that toluidine blue is more specific to higher grades of dysplasia and cancer whereas fluorescence is quite sensitive to even quite mild types of tissue change and is thus very good at identifying the full scope of mucosal involvement of a particular lesion. Loss of Fluorescence Copyright ® 2002-2007 by Oral Health Study, Oral Oncology/Dentistry, BCCA

Dysplasia Caught Early Polyp Mild Dysplasia CIS Polyp (green) With VELscope you can see the area very clearly. Again, this was confirmed by biopsy to be CIS. Clinical Appearance Suspicious region is now clearly visible. Confirmed CIS. Images courtesy of the British Columbia Oral Cancer Prevention Program

Severe Dysplasia on Alveolar Ridge Clinical Impression: Denture Trauma? Excisional Biopsy: Severe Dysplasia Inflammation resolved in 2 weeks after removal of denture Images courtesy of the University of Washington Oral Medicine Program

When Do Observe or Refer? In this case from the BCCA you can see the leukoplakia in the left image. In the image on the right, you can see that the lesion appears as an irregular, dark area. This area was biopsied and was found to be severe dysplasia. Images courtesy of the British Columbia Oral Cancer Prevention Program

Oral Lesions May Show as Observe or Refer? In this case from the BCCA you can see the leukoplakia in the left image. In the image on the right, you can see that the lesion appears as an irregular, dark area. This area was biopsied and was found to be severe dysplasia. Excisional Biopsy: Severe Dysplasia Oral Lesions May Show as Irregular, Dark Areas Images courtesy of the British Columbia Oral Cancer Prevention Program

Observe or Refer? An Oral Lesion that Shows Hyperplasia In this case from the BCCA you can see the white region in the left slide. The difference from the previous slide is that in the slide on the right you can see that the lesion is VELscope Negative. This area was biopsied and found not to be dysplasia. An Oral Lesion that Shows No Change in Autofluorescence Appearing Pale Green Images courtesy of the British Columbia Oral Cancer Prevention Program

Patient referred for the suspicious lesion on the lip Patient referred for the suspicious lesion on the lip. The true area of concern was in the floor of the mouth detected by a VELscope at NYU. SCC New York University, Dept of Oral Medicine

Moderate Dysplasia Dept of Oral Medicine, University of Washington

Pre-clinical discovery Can you see the are Left palate : low-grade mucoepidermoid carcinoma

Blanching under Diascopic Pressure Using an instrument to blanch is a technique1 for indicating whether or not an abnormality has an inflammatory component. Using an instrument to blanch a dark area under VELscope can be a useful technique for indicating whether or not an abnormality has an inflammatory component. This particular area blanches completely. Treatment and subsequent follow-up after two weeks resulted in complete resolution. This particular area is inflammation and blanches completely Treatment and follow-up in two weeks showed complete resolution Rudd M, Eversole R, Carpenter W. “Diascopy: a clinical technique for the diagnosis of vascular lesions”, Gen Dent. 2001 Mar-Apr; 49(2):206-9.

EXTENSIVE CLINICAL SUPPORT 10+ Years of Research in the Oral Cavity 2011 General Dentistry – E. Truelove, et al. 2009 General Dentistry – K. Huff, et al 2007 Head & Neck – P.M. Williams, et al. 2006 Clinical Cancer Research – C.F. Poh, et al 2005 Oral Oncology – deVeld, et al. Proven Efficacy www.VELscope.com/research There is over 10 Years of Research in Peer Reviewed Journal articles proving the efficacy of the VELscope. Many studies, including the ones listed here demonstrate the ability of the VELscope to detect lesions that are not readily visible and it gives the ability to a surgeon to be used as a tool to determine where and how much tissue to excise.

“Since we have incorporated the VELscope in our practice we have had three positive oral carcinomas treated by oral and plastic surgeons in 2 1/2 years. Numerous biopsies have resulted in the removal of worrisome and non malignant growths which has increased our patient acceptance and referrals. Thanks for the technology.” Thomas R. Leischner DDS Elk Grove Village, IL

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