MelaFind Brochure

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
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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
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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.