|By Business Wire||
|January 22, 2014 07:55 AM EST||
MELA Sciences, Inc. (NASDAQ: MELA), developer of MelaFind®, an FDA approved optical diagnostic device that assists dermatologists in the diagnosis of melanoma, today announced the results of its third company-sponsored Clinical Advisory meeting hosted during the Winter Clinical Dermatology Conference in Hawaii where technical advancements of MelaFind® and future technology development opportunities were discussed and user’s validated its clinical use. MELA Sciences also displayed four clinical posters presentations at the conference, which took place from January 17 – 22, 2014.
The poster presentations reviewed clinical data derived from practice and clinical settings that highlighted how MelaFind has helped dermatologists in the assessment of clinically ambiguous pigmented skin lesions in various patients including young adults, an area of growing concern, and those with atypical mole syndrome. To view the posters and their accompanying abstract please click here.
The poster authored by Dr. Darrell Rigel, titled Physical Properties, Novel Features and Clinical Validation of a Multispectral Digital Skin Lesion Analysis Device for Melanoma, and outlined below was named Poster of the Day on the first day of the conference.
Highlights of the studies and the data shown in the poster presentations are as follows:
Physical Properties, Novel Features and Clinical Validation of a Multispectral Digital Skin Lesion Analysis Device (MSDSLA) for Melanoma Detection - Darrell S. Rigel, MD, MS NYU School of Medicine, New York, NY; Laura Ferris, MD, PhD, University of Pittsburgh. Pittsburgh, PA; Arthur Sober, MD, Harvard University, Boston, MA; Clay J. Cockerell, MD, University of Texas Southwestern, Dallas, TX
- Retrospective data from the MelaFind pivotal study was used to investigate the MelaFind multispectral images and classifier score result as a tool to differentiate cutaneous melanoma from other pigments skin lesions.
- Results showed the average classifier scores of melanomas, high-grade lesions, non-melanoma skin cancers, and histologically benign nevi were 3.5, 2.7, 2.6 and 1.6 respectively.
- Further results showed an increase in the mean classifier score result with each additional clinical characteristic present in the lesion.
Assessing the Predictive Probability of Melanoma and Other High Risk Pigmented Lesions Using Data Provided by a Multispectral digital Skin Lesion Analysis Device - Jane Yoo, MD, MPP, Dept. of Dermatology, Albert Einstein School of Medicine, Bronx, NY; Natalie Tucker, BS, MELA Sciences, Irvington, NY; Darrell S. Rigel, MD, MS, Dept. of Dermatology, NYU School of Medicine, NYC, NY
- A risk prediction model was built to assess the predictive probability of melanoma or a high-risk lesion for consideration for biopsy based on data obtained from MelaFind.
- Results show a potential quantitative predictive capacity for presence of melanoma and other high risk pigmented lesions using the MelaFind device.
In addition to presenting data from the four studies, MELA Sciences held its third Clinical Advisory Meeting for current and prospective MelaFind users and thought leaders. In attendance was Dr. Antonanella Calame, dermatologist, dermatopathologist and medical director of Compass Dermatology and Dermatopathology in La Jolla, CA. Dr. Calame, a user of MelaFind, said, “As dermatologists, one of our most important goals is diagnosing melanoma, the deadliest form of skin cancer, at its earliest and most curable stage. The MelaFind system’s images and data analysis tools help dermatologists with one of the most challenging questions we face each day when evaluating clinically ambiguous pigments skin lesions: “Is this lesion atypical enough for me to remove and investigate further via histology?” MelaFind’s analysis of a lesion’s architectural structure gives us access to new information deeper into the skin, where the human eye cannot see, and helps us answer this critical question, improving overall outcomes for both patient and clinician. These tools are available for the first time in medicine and MelaFind is just the beginning. If patient outcomes are our foremost concern, adoption of such technologies should be widespread and soon become part of the standard of care.”
The Winter Clinical Dermatology Conference was conducted over four days and had nearly 400 participants from various fields of dermatology, medical and cosmetic. In discussing the Advances in the Diagnosis of Melanoma, Dr. Laura Ferris credited MelaFind as an important instrument in helping to detect melanoma.
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About MELA Sciences, Inc. www.melasciences.com
MELA Sciences is a medical device company developing dermatology diagnostics utilizing state-of-the-art optical imaging. The flagship product is MelaFind®, an FDA, PMA and CE Mark approved, non-invasive diagnostic tool to aid dermatologists in melanoma evaluation and diagnosis. MelaFind® uses a variety of visible to near-infrared light waves to evaluate skin lesions from the surface to 2.5 mm beneath the skin. It provides images and data on the relative disorganization of a lesion's structure that provides substantial additional perspective to aid melanoma diagnosis. MELA is also exploring new potential uses for its core imaging technology and algorithms.
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 may contain words such as “seeks,” “look forward,” and “there seems” that suggest future events or trends. These statements are based on our current expectations and are inherently subject to significant uncertainties and changes in circumstances. Actual results may differ materially from our 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 set forth in the company’s SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any or all of these forward-looking statements may prove to be incorrect or unreliable. MELA Sciences assumes no duty to update its forward-looking statements and urges investors to carefully review its SEC disclosures available at www.sec.gov and www.melasciences.com.
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