New Data Presented at the Fall Clinical Dermatology Conference Supports
MelaFind(R) as a Fundamental Tool for Dermatologists
Leading Dermatologists Presented Findings in Four Poster Presentations at the
32nd Annual Fall Clinical Dermatology Conference in Las Vegas, Nevada
IRVINGTON, N.Y., Oct. 21, 2013 (GLOBE NEWSWIRE) -- MELA Sciences, Inc.
(Nasdaq:MELA), a leader in the fight against melanoma with MelaFind®, the
first and only FDA approved optical diagnostic device for melanoma detection
used by dermatologists, today announced the results of four studies which were
displayed in poster presentations at the Fall Clinical Dermatology Conference
which took place from October 17 – 20, 2013 in Las Vegas, Nevada. MELA
Sciences also held its first Clinical Advisory meeting where the company
announced the launch of a new user study called the MelaFind Experience Trial
The poster presentations at the conference showed data derived from four
studies in real world American and German dermatology practices that
highlighted how MelaFind has helped dermatologists with mole management of
atypical lesions.The studies also demonstrated how MelaFind may be useful to
dermatologists in evaluating lesions on atypical mole syndrome patients and on
young adults, which is a growing concern.
Highlights of the studies and the data shown in the four poster presentations
are as follows:
Atypical Mole Syndrome Patients and Multispectral Digital Skin Lesion Analysis
Harold S. Rabinovitz, MD, Skin and Cancer Associates Center for Cosmetic
Enhancement^®, Plantation, FL; Margaret Oliviero, ARNP, MSN, Skin and Cancer
Associates Center for Cosmetic Enhancement^®, Plantation, FL; Nikolai
Kabelev, MELA Sciences, Inc., Irvington, NY; Dina Gutkowicz-Krusin, PhD, MELA
Sciences, Inc., Irvington, NY
*Study of 1,000 lesions on ten patients with atypical mole syndrome were
evaluated with MelaFind.
*Results suggest improved specificity on atypical lesions using baseline
To Excise or Not: How Does a Multispectral Digital Skin Lesion Analysis Device
(MSDSLA) Impact Dermatologist Decisions to Biopsy Melanomas?
A Hauschild, MD, University Hospital Schleswig-Holstein (UKSH), Campus Kiel,
Kiel, Germany; SC Chen, MD, Emory University and Atlanta Veterans
Administration Medical Center, Atlanta, GA, USA; M Weichenthal, MD,
University Hospital Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany; A
Blum, MD, Public, Private and Teaching Practice of Dermatology, Konstanz,
Germany; H King, MD, Weill Medical College of Cornell University, New York, NY
and MELA Sciences, Inc. Irvington, NY, USA; J Goldsmith, PhD, Columbia
Mailman School of Public Health, New York, NY, USA; D Scharfstein, ScD, Johns
Hopkins University, Baltimore, MD, USA;D Gutkowicz-Krusin, PhD, MELA
Sciences, Inc., Irvington, NY, USA
*Over 200 German dermatologists reviewed images for 130 lesions and
indicated whether or not they would biopsy each lesion; half of the
dermatologists also received the corresponding MelaFind information.
*Dermatologists with MelaFind elected to biopsy more lesions and detected a
significantly higher number of melanomas than those without MelaFind (22
Dermatologists vs. 3 without MelaFind detected over 90% of the melanomas
in the study, p = 0.00006).
*Conclusion: Incorporating MelaFind into examinations for melanoma can
prove to be a valuable tool leading to improved biopsy decisions and
patient mole management.
Review of Multispectral Digital Skin Lesion Analysis Device (MSDSLA) use in a
Private Practice Clinical Setting
Gregory Nikolaidis, MD; Laura Speck, MD; Hadley King, MD; Darrell Rigel, MD
*Data from 100+ patients during the first 7 days of MelaFind use at a
private multi-location practice with 12 dermatologists.
*Results showed higher rate of MelaFind "Low" readings in large real-world
study than in pivotal study.
*MelaFind data used in detecting 1 melanoma and 7 clinically important
lesions requiring re-excision.
*Conclusion: Even with limited experience using the device, MelaFind was
useful in assisting dermatologists to identify a melanoma and high-grade
lesions while also sparing unnecessary biopsies of healthy tissue.
Case Study: MelaFind Use in Young Patients
Marcella Kollmann, MD
*Younger patients tend to experience high biopsy rates (~80:1); new tools
such as MelaFind can be helpful in narrowing down the criteria for biopsy
by providing additional information.
*One young man with no risk factors for melanoma was diagnosed with
melanoma after a MelaFind "High Disorganization" reading.
*One young woman with an unsuspicious lesion followed for years had this
lesion biopsied after a MelaFind "High Disorganization" reading which was
subsequently diagnosed as melanoma.
During the Fall Clinical Dermatology Conference, Marcella Kollmann, MD, who
was among the first to use MelaFind® in Germany, shared her findings on mole
management and described cases from her own experience of early melanomas
detected with the aid of MelaFind. "When it comes to mole management, nearly
all dermatologists in Germany use dermoscopy, and the majority have body
mapping systems, and the next step is using spectral imaging and data analysis
from MelaFind®, which can improve the diagnosis of early melanoma and high
grade dysplastic nevi. I've been working with the technology for over a year
and a half.It has been very useful in managing moles in younger patients and
children, as well as in high-risks patients and has a very high patient
acceptance. It is especially valuable if you see the patient on a regular
basis for skin cancer examinations because you can compare the MelaFind
information over a period of time."
In addition to presenting data from the four studies, MELA Sciences held its
first Clinical Advisory Meeting of experienced users. New insights and
experiences were presented and shared in an open forum by leading American and
German thought leaders in melanoma and pigmented skin lesions. Additionally,
Dr. Darrell Rigel, Chief Medical Advisor to the Board of MELA Sciences,
initiated the MET-1 study for participants and key users of MelaFind to
demonstrate the important value the system offers in caring for their high
The 32^nd Fall Clinical Dermatology Conference had over 700 participants
during a four-day, sold-out medical meeting attended by dermatologists,
dermatology residents, fellows, physician assistants and nurse practitioners.
It offered cutting-edge information on the diagnosis and treatment of various
conditions related to medical, surgical and cosmetic dermatology.
MelaFind® is the first and only FDA-approved optical imaging device for
melanoma detection used by dermatologists and was recognized by the Cleveland
Clinic as a Top 10 Medical Innovation for 2013. MelaFind was featured in the
Wall Street Journal and recently received national attention on "The Rachael
Ray Show". Consumers can learn more about the device or locate a MelaFind®
dermatologist in their area by visiting www.melafind.com.
About MELA Sciences, Inc.
MELA Sciences, Inc. is a medical device company focused on the
commercialization of its flagship product, MelaFind® and its further design
and development.MelaFind® is a non-invasive tool that provides additional
information to dermatologists during melanoma skin examinations. The device
uses light from visible to near-infrared wavelengths to evaluate skin lesions
up to 2.5 mm beneath the skin. The device supplies information on a lesion's
level of morphologic disorganization to provide additional objective
information that may be used by dermatologists in the biopsy decision-making
process. MelaFind® has been approved by the U.S. Food and Drug Administration
for use in the U.S. In addition, MelaFind® has received CE Mark approval and
is approved for use in the European Union.
For more information on MELA Sciences, Inc., visit www.melasciences.com.
This press release includes "forward-looking statements" within the meaning of
the Securities Litigation Reform Act of 1995. These statements include but are
not limited to our plans, objectives, expectations and intentions and other
statements that contain words such as "expects," "contemplates,"
"anticipates," "plans," "intends," "believes," "assumes," "predicts" and
variations of such words or similar expressions that predict or indicate
future events or trends, or that do not relate to historical matters. These
statements are based on our current beliefs or expectations and are inherently
subject to significant known and unknown uncertainties and changes in
circumstances, many of which are beyond our control. There can be no assurance
that our beliefs or expectations will be achieved. Actual results may differ
materially from our beliefs or expectations due to financial, economic,
business, competitive, market, regulatory and political factors or conditions
affecting the company and the medical device industry in general, as well as
more specific risks and uncertainties facing the company such as those set
forth in its reports on Forms 10-Q and 10-K filed with the U.S. Securities and
Exchange Commission (the "SEC"). Factors that might cause such a difference
include whether MelaFind® achieves market acceptance. Given the uncertainties
affecting companies in the medical device industry such as the Company, any or
all of these forward-looking statements may prove to be incorrect. Therefore,
you should not rely on any such factors or forward-looking statements. The
Company urges you to carefully review and consider the disclosures found in
its filings with the SEC which are available at www.sec.gov and
CONTACT: For further information contact:
Lynn Pieper, Westwicke Partners, 415-202-5678
Erica Sperling, Rpr Marketing Communications,
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