IRVINGTON, NY--(Marketwire - October 19, 2010) - MELA Sciences, Inc. (
"We are extremely pleased to see the results of the MelaFind® pivotal trial reviewed by outside dermatology experts and published in this prestigious medical journal in the field of dermatology," said Joseph V. Gulfo, MD, President and CEO of MELA Sciences. "We remain diligently focused on preparing for the November 18th panel meeting where these data will be presented to and discussed with the Food and Drug Administration's advisors."
The paper shows that MelaFind's performance satisfied all primary and secondary sensitivity and specificity endpoints, as defined by the study protocol and a Protocol Agreement between MELA Sciences and the FDA. The Protocol Agreement calls for 95% lower confidence bound on sensitivity to be greater than 95% and for MelaFind® to be more specific than the study physicians at a p-value of less than 0.05. Since the measured values of sensitivity were very high, the "exact mid-P" statistical method was used to compute the 95% lower confidence bound. Specificity endpoints were based on relative performance of MelaFind® and investigators, with significance established at p-value less than 0.05.
In order to generate a comparison with dermatologists' biopsy sensitivity to melanoma, MELA Sciences conducted a parallel pilot readers' study with 39 other dermatologists who were blinded to the study results. Importantly, the average biopsy sensitivity of the readers was only 80%, and the inter-reader variability was high.
"The pilot reader study found that dermatologists do miss early melanomas," study author Kenneth Gross, MD, said. "Only 20% of the melanomas in the pilot reader study would have been biopsied by all readers and different readers missed different melanomas. Thus, even though all lesions in the clinical trial were biopsied by the examining dermatologists, many of the melanomas would not have been biopsied by other dermatologists, underscoring the need for an objective tool to aid in the decision to biopsy. We believe that the results of the pivotal trial and the pilot reader study underscore the clinical utility of MelaFind® as an objective tool to aid clinicians in the detection of early melanoma."
About MELA Sciences
MELA Sciences is a medical technology company focused on developing MelaFind®. MelaFind® is a non-invasive and objective multi-spectral computer vision system designed to aid physicians in the detection of early melanoma from among clinically atypical (those having one or more clinical or historical characteristics of melanoma, such as asymmetry, border irregularity, color variegation, diameter greater than 6 millimeters, evolving, patient concern, regression, and ugly duckling) cutaneous pigmented lesions that are non-ulcerated, not bleeding, and less than 2.2 centimeters in diameter, when a physician chooses to obtain additional information before making a final decision to biopsy to rule out melanoma.
The MelaFind® Pre-Market Approval (PMA) application was filed with the U.S. Food and Drug Administration (FDA) in June 2009 and is currently under review at the FDA. MELA Sciences cannot predict either the timing of the FDA's decision on the PMA application or the outcome. FDA approval is required prior to marketing MelaFind® in the United States.
For more information on MELA Sciences, visit www.melasciences.com.
Safe Harbor
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" 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 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 economic, business, competitive, market and regulatory factors.
Contact Information:
For further information contact:
For Investors:
David Carey
Lazar Partners, Ltd.
646-871-8485
For Media:
Hollister Hovey
Lazar Partners, Ltd.
646-871-8485