IRVINGTON, N.Y., March 18, 2013 /PRNewswire/ -- Research presented by MELA Sciences, Inc. (MELA) at the 71st Annual Meeting of the American Academy of Dermatology (AAD) shows that MelaFind® can increase the melanoma detection rates of resident dermatologists when deciding to biopsy melanoma at its most curable stage. The data offers new insight into the importance of skin checks appropriately assisted with MelaFind®, as the rates of melanoma continue to rise in the United States.
The study, led by Drs. Jane A. Yoo and Darrell S. Rigel, asked 121 resident dermatologists to evaluate 24 pigmented lesions that had previously been analyzed by MelaFind®. Biopsy performance results were compared before and after using the MelaFind® "High" or "Low" Disorganization score. Prior to factoring in results from MelaFind®, dermatology residents' biopsy sensitivity was 57%. After reviewing MelaFind® results, sensitivity improved to 77%. The results, combined with data from a similar study of attending dermatologists, showed that utilizing MelaFind® can significantly improve the melanoma detection rates of dermatologists at any experience level.
Skin cancer rates continue to rise, while many other cancer rates decline.1 "Only 24% of American adults have had a skin check with a dermatologist.2 We want to increase those numbers to help combat melanoma, which has reached epidemic proportions, with one American dying every hour,3" said Dr. Joseph Gulfo, President and CEO of MELA Sciences, Inc. "The data presented at AAD reinforces the importance of MelaFind® and how the tool helps dermatologists detect melanoma at its most curable stage."
"The data demonstrates that MelaFind® increases the performance of dermatologists in their decision whether to biopsy melanoma at its most curable stage," said Darrell S. Rigel, MD, Clinical Professor of Dermatology, New York University. "MelaFind® continues to prove itself to be a worthy diagnostic tool for dermatologists to implement during skin cancer checks."
MELA Sciences, Inc. is the pioneer company that developed MelaFind®, the first and only FDA-approved diagnostic tool to detect melanoma at its most curable stage. MelaFind® sees 2.5 mm under the skin and uses multi-spectral light technology to provide dermatologists with additional information of a "High" or "Low" Disorganization score when deciding which ambiguous moles to biopsy during skin examinations. In the MelaFind® Pivotal Trial, which was the largest positive prospective clinical study ever conducted in melanoma detection, MelaFind® detected 98.3% of the melanomas.
This data and other information on MelaFind® was presented during 10 podium talks during AAD, the topics of which included skin cancer, melanoma, new diagnostic tools in the clinical diagnosis and management of melanoma, total body skin checks, and detection of melanoma at its most curable stage. At AAD, more than 650 dermatologists engaged directly to learn more about MelaFind® for their practices; 350 of which received live, in-depth demonstrations.
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 to provide 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 provides 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 US Food and Drug Administration for use in the US. 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 www.melasciences.com.
1 Cancer.org Facts and Figures Report: Declines in Cancer Deaths Reach Milestone. http://www.cancer.org/cancer/news/facts-and-figures-report-declines-in-cancer-deaths-reach-milestone Accessed January 17, 2013.
2 Harris Interactive on behalf of MELA Sciences, Inc., January 2013; among 2,109 U.S. adults (aged 18 and over)
3 American Cancer Society. Cancer Facts & Figures 2013. http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-036845.pdf. Accessed January 31, 2013.
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