Jun 5 2014
MELA Sciences, Inc., developer of the MelaFind® system, an optical diagnostic device approved for use in the United States and the European Union to assist dermatologists in melanoma diagnosis, today announced that it has initiated a study to examine the real-world clinical impact of MelaFind on dermatologists' decision to biopsy pigmented skin lesions that are suspicious for melanoma.
Darrell Rigel, MD, MS, Clinical Professor of Dermatology at New York University Langone Medical Center, will be the Principle Investigator for the study.
Rose Crane, MELA Sciences President and CEO, commented, "This trial is significant as the data will be based on patient assessments by dermatologists using the MelaFind system. It will provide us with a measure of the real-world clinical impact of MelaFind on melanoma diagnosis, and we believe it will support our case for insurance reimbursement. We welcome Dr. Rigel's oversight as the principal investigator of this important study."
Study Overview
This real world study, preliminary results of which are expected by year end 2014, will evaluate the impact of the MelaFind system information on dermatologists' biopsy decisions. It will compare their clinical assessment and biopsy decision of suspicious pigmented skin lesions both before and after the use of MelaFind. Participating dermatologists will be current users of the MelaFind system. The study will determine the impact of the MelaFind system information on their diagnostic accuracy as well as the impact of the MelaFind information on the total number of biopsies performed.
This study will be the first of its kind to generate information on the real-world impact of the MelaFind system on a dermatologist's decision to biopsy a suspicious pigmented skin lesion. Approximately 15 dermatology practices across the United States will participate in the data collection, with the goal of accruing information on over 150 lesions. The Company is also conducting a similar though larger scale Post Approval Study of MelaFind, the preliminary results of which are expected in 2017.
About MelaFind www.melafind.com
MelaFind® is the first and only medical device with FDA Pre-Market Approval (PMA) for the U.S. and CE Marking certification for the European Union designed to assist dermatologists in the evaluation and diagnosis of melanoma at its most curable stage. The MelaFind® system utilizes innovative software driven technology and state-of-the-art 3-D optical imaging to non-invasively extract data 2.5 mm below the skin surface from patient's pigmented ambiguous moles and objectively analyzes them with proprietary algorithms. MelaFind provides important additional perspective to physicians via 3-D spectral images and 100% objective data analysis to help them better understand the structural disorganization of a patient's pigmented ambiguous moles (before cutting the skin) during the evaluation and diagnosis process for melanoma - a powerful modern tool to assist their traditional methods (ABCDEPRU).
About MELA Sciences, Inc. www.melasciences.com
MELA Sciences is a medical technology company dedicated to designing and developing innovative software-driven technology for the clinical early detection and prevention of skin cancer. MELA Sciences conducted the largest, positive prospective study ever done on the melanoma disease, and is the first and only medical technology company to receive both FDA Pre-Market Approval (PMA) for the U.S. and CE Marking certification for the European Union for a device of this nature.