MELA recently announced positive topline results in a pivotal clinical trial for MelaFind, which was conducted at seven medical centers across the U.S. and included nearly 1,400 patients and over 1,800 pigmented skin lesions. A larger study will also be conducted for MelaFind, with the results planned for submission to the FDA.
Emerging Diagnostics Index: http://biomedreports.com/health-indexes.html
The Company is currently preparing to file a PMA (with a six-month priority review designation and advisory panel meeting expected) for medical device marketing approval from the FDA based on the study findings, which represents the largest prospective study for melanoma detection.
BioMedReports.com FDA Calendar: http://biomedreports.com/fda-calendar.html
MelaFind demonstrated 98% sensitivity (correctly identifying the disease when it is actually present) in the detection of melanomas (identifying 125 out of 127 overall melanomas) and 9.5% specificity (ability to rule out the disease when it is not present), compared to 3.6% for the 39 dermatologists who participated in the study.
The major advantage of MelaFind is the ability to examine lesions below the skin surface. The device is meant to aid dermatologists by going beyond skin surface examinations and providing additional data to determine if a more invasive biopsy is required for suspicious lesions.
An estimated 650,000 people in the U.S. visit a dermatologist each year because of a suspicious skin lesion and experts estimate that 4-10 million Americans have risk factors for the development of melanoma. Early diagnosis of melanoma is crucial for effective treatment and survival, as it represents the fastest growing cancer (6% annually) which is responsible for 80% of all skin cancer deaths.
The MelaFind System is an objective diagnostic screening test that incorporates 10 different wavelengths, which was developed and tested on 600 different melanomas. MelaFind works by taking 10 digital images across the different wavelengths, which are processed by algorithms based on a database including 9,000 skin lesions and 600 melanomas. The system provides the clinician with an immediate result to aid in the decision of whether to perform a biopsy.
MELA ended the year with $15.4M in cash, 20.6M fully diluted shares of common stock, a 17.6M net loss over the past 12 months, a market cap of $80M, and an expected cash burn rate of $1.3M per month going forward.
$4.45 (03/16/09)
