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 (MET-1).
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 Device (MSDSLA)
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 thresholding.
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 risk patients.
The 32nd 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.
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