What is MelaFind®? Know Your Moles MelaFind® is brand new medical technology that is used during a skin exam or mole check to help dermatologists see under the skin’s surface. MelaFind® can help your dermatologist determine how irregular the growth pattern of your mole is under the skin. Check your moles between skin exams. Melanoma often appears in an existing mole or looks like a new mole. By knowing where you have moles on your skin, you can find melanoma when it first appears. When treated early, melanoma is often curable.1 If you notice any of the warning signs listed below, see your dermatologist immediately. Here’s what to look for: How does MelaFind® work? MelaFind® collects information from 2.5 mm deep into the skin, using computer vision technology. MelaFind® then analyzes that information and gives feedback on how irregular or peculiar your mole is under the skin. Does MelaFind use x-ray light? No. MelaFind® uses light of 10 different wavelengths, from blue (430nm) to near infrared (950nm), to illuminate the mole for data capture; neither ultraviolet light nor X-rays are employed. . A mole on the skin that is growing, changing shape, or changing color . A mole that looks scaly, oozes, or bleeds . Frequently Asked Questions N ew dark spot on the skin that looks like a mole, but grows quickly . P ain, itching, or bleeding in a new spot on the skin . S treak (usually brown or black) underneath a fingernail or toenail . B ruise on the foot that does not heal ® Is MelaFind® a body scanner? No. A scan means that MelaFind® would be used on all of your moles. MelaFind® should only be used on irregular-looking or peculiar moles that your dermatologist wants more information about. Is MelaFind® painful? No. MelaFind® is placed lightly on top of the skin and is painless. Minor irritation may result from the application of alcohol. Does MelaFind® cause scarring? No. MelaFind® is non-invasive, therefore, it leaves no scars. If your dermatologists chooses to biopsy an irregular mole, a scar may develop at the biopsy site. www.melafind.com While MelaFind ® is intended to be used when a dermatologist chooses to obtain additional information for a decision to biopsy, MelaFind ® should NOT be used to confirm a clinical diagnosis of melanoma. As with all tools to provide additional information during skin exams, there is a risk that melanomas will be missed and benign moles will be biopsied. MelaFind ® is indicated for use on clinically atypical cutaneous pigmented skin lesions with a diameter between 2 mm and 22 mm that are accessible by MelaFind ®, sufficiently pigmented (i.e. not for use on non-pigmented or skin-colored lesions), that do not contain a scar or fibrosis consistent with previous trauma, where the skin is intact (i.e., non-ulcerated or non-bleeding lesions), that are greater than 1 cm away from the eye, which do not contain foreign matter, or that are not on special anatomic sites (i.e., not for use on acral, palmar, plantar, mucosal, or subungual areas). Reference: 1. http://www.aad.org/skin-conditions/ dermatology-a-to-z/skin-cancer/signs-symptoms 50 South Buckhout St. • Suite 1 • Irvington, NY 10533 www.melasciences.com ©2012 MELA Sciences, Inc. <code> 4/12 www.melafind.com What is Melanoma? Melanoma is the most dangerous form of skin cancer. Skin cancer occurs when cells grow abnormally and uncontrollably. One way to identify melanoma is to look for moles with irregular growth patterns. What is an irregular mole? An irregular mole is a mole that has at least one characteristic in common with melanoma. These characteristics can be: Asymmetry (one half of the mole is different from the other half), Border (the border or edges of the mole are uneven, fuzzy, notched or irregular), Color (the mole has multiple colors or the color is uneven), Diameter (the size of the mole is greater than 6 mm), Evolving (a mole that has changes in ABC or D over time), Personal Concern (you have a concern about your mole), Regression (mole has scar-like white appearance), Ugly Duckling (a mole that looks different from other moles on your body). What is a skin lesion? A skin lesion is a superficial growth or patch of the skin that does not resemble the area surrounding it. How do I know if I am at risk for melanoma? Everyone is at risk for melanoma, even people who are not fair-skinned, have never spent a lot of time in the sun, have always used sunscreen, and have no family history of melanoma. That is why it is so important to have your skin examined regularly by a dermatologist. For more information on skin cancer and melanoma, please visit the American Cancer Society website at www.cancer.org www.melafind.com What does MelaFind® Tell Me? When Should MelaFind® Be Used? MelaFind® uses 10 different wavelengths of light to “see” beneath the surface of the skin and obtain hidden data from a mole as deep as 2.5 mm. The data are processed by the MelaFind® system, which uses advanced computer programs to analyze the features of the mole. In under a minute, MelaFind® tells your dermatologist if the mole has irregular growth patterns underneath the skin. Your dermatologist will receive either a “High Disorganization” output, or a “Low Disorganization” output. This is an indicator of the extent of peculiar cellular growth patterns under the surface. MelaFind® is designed for use on moles that are peculiar. During a skin exam, dermatologists visually evaluate moles. Sometimes, your mole may have irregular features that can cause your doctor to take a closer look. Irregular moles can be harmless, but in some cases, they can be a melanoma. During your exam your dermatologist may decide that you are a candidate for MelaFind®. What does “High Disorganization” mean? “High Disorganization” means that there is a high level of irregular growth patterns in your mole, but it does not mean the mole is melanoma. Some harmless moles may also have irregularities. Your dermatologist will use the MelaFind® data along with other information measures of irregularity to decide whether or not your mole should be removed. What does “Low Disorganization” mean? “Low Disorganization” means that there is a low level of irregular growth patterns in your mole. Your dermatologist may still choose to remove your mole based on other information. Based on the MelaFind® output, along with other information about the key characteristics of the mole, your dermatologist will decide if the mole should be removed. Will MelaFind® guarantee that my dermatologist has found all melanomas on my body? MelaFind® is not intended to be a screening device and will only be used on moles that your dermatologist determines are irregular-looking and would like more information about. As with all tools to provide additional information during skin exams, there is a risk that melanomas will be missed and benign moles will be biopsied. Will MelaFind® reduce the number of biopsies on normal moles that I have to undergo? The ultimate decision to biopsy or not biopsy a mole is at the sole discretion of your dermatologist. MelaFind® is intended to provide additional information to your dermatologist when making this decision. In clinical studies, MelaFind® was shown to detect melanoma at a very high rate (98%) with fewer biopsies of moles that were benign. Should I ask my dermatologist to use MelaFind® on all of my moles? No. MelaFind® is intended to be used on irregular looking moles when a dermatologist chooses to obtain additional information when deciding whether or not to biopsy a mole. MelaFind® is NOT a screening device.
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