|Traded as||NASDAQ: MELA|
|Headquarters||Irvington, New York, United States|
MELA Sciences is an American medical device company focused on the design, development and commercialization of non-invasive tools to provide additional information to dermatologists during melanoma skin examinations. The company’s flagship product, MelaFind®, is intended to be used when a trained dermatologist chooses to obtain additional information to help decide whether to biopsy certain clinically atypical pigmented skin lesions. The FDA has approved MELA Sciences’ MelaFind® pre-market approval application for use in the United States. Following completion of a successful conformity assessment procedure, MELA Sciences has also been granted CE Mark approval for sale of MelaFind® in the European Union..
If caught early, melanoma can be cured
Melanoma is the deadliest form of skin cancer, responsible for about 75% of skin cancer fatalities, according to the Skin Cancer Foundation.
There are an estimated 135,000 new cases of melanoma diagnosed in the U.S. every year.
Every hour, one person in the U.S. dies of melanoma and 15 people are diagnosed with the disease, according to the American Cancer Society.
What causes melanoma?
Melanoma is frequently caused by exposure to the sun, which triggers the uncontrolled growth of skin pigment cells or melanocytes. On the surface of the skin, melanoma can look like other irregular, harmless moles. However, beneath the surface there may be a peculiar cellular growth pattern.
Anyone can get melanoma, though it is more prevalent in certain parts of the country and among Caucasians. Dermatologists are especially concerned because melanoma is the most common cancer in people aged 25-29 and the second most common cancer in teens and young adults aged 15-29.
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The FDA has approved MELA Sciences’ MelaFind® Pre-Market Approval application for use in the United States. Following completion of a successful conformity assessment procedure MELA Sciences has also been granted CE Mark approval for sale of MelaFind® in the European Union.
The FDA and MELA Sciences have agreed to the following labeled indications for use of MelaFind®in the U.S.:
MelaFind® is intended for use on clinically atypical cutaneous pigmented lesions with one or more clinical or historical characteristics of melanoma, excluding those with a clinical diagnosis of melanoma or likely melanoma. MelaFind® is designed to be used when a dermatologist chooses to obtain additional information for a decision to biopsy. MelaFind® should NOT be used to confirm a clinical diagnosis of melanoma.
MelaFind® is only for use by physicians trained in the clinical diagnosis and management of skin cancer (i.e., dermatologists) who have also successfully completed a training program in the appropriate use of MelaFind®.
The MelaFind® result is one element of the overall clinical assessment of clinically atypical lesions. A “High Disorganization” MelaFind® output indicates lesions (which may include malignant melanoma, melanoma in situ, high grade dysplastic nevi and atypical melanocytic proliferation/hyperplasia) that should be considered for biopsy; the biopsy decision of a “Low Disorganization” MelaFind® output should be based on the remainder of the entire clinical context. Lesions that are “non-evaluable” by MelaFind® should be carefully re-evaluated for biopsy.
MelaFind® is indicated only for use on lesions with a diameter between 2 mm and 22 mm, lesions that are accessible by the Hand-Held component of MelaFind®, lesions that are sufficiently pigmented (i.e. not for use on non-pigmented or skin-colored lesions), lesions that do not contain a scar or fibrosis consistent with previous trauma, lesions where the skin is intact (i.e., non-ulcerated or non-bleeding lesions), lesions greater than 1 cm away from the eye, lesions which do not contain foreign matter, and lesions not on special anatomic sites (i.e., not for use on acral, palmar, plantar, mucosal, or subungual areas). MelaFind® is not designed to detect pigmented non-melanoma skin cancers, so the dermatologist should rely on clinical experience to diagnose such lesions.
The Hand-Held component of MelaFind®, used to capture multi-spectral data from beneath the surface of lesions, is made up of:
An illuminator that shines light of 10 different specific wavelengths, including near infrared bands A lens system composed of 9 elements that creates multi-spectral data of the light scattered back from the lesions A photon (light) sensor
MelaFind’s automatic data analysis algorithms include:
Calibration to reduce noise and artifacts in the data Quality control to automatically detect problems such as overexposure, underexposure, inappropriate lesion size or too much hair and when appropriate, direct the MelaFind® operator to re-evaluate the lesion Lesion segmentation to identify portions of the data that belong to the lesion Feature extraction to compute parameters characterizing lesions Lesion classification to classify clinically atypical pigmented skin lesions based upon degree of 3D morphological disorganization providing an output of “High Disorganization” or “Low Disorganization”
Development and training of the lesion classification algorithm is an iterative process involving: (1) creation and enrichment of the lesion database and complementary gold-standard (pathology) information; (2) development of the lesion features that provide discrimination; (3) development of algorithms that enable computers to effectively “learn” based on examples; (4) training of the computer using these algorithms to arrive at the best-performing classifier; and (5) repeating the process. The performance of the lesion classification algorithm is directly related to the size of the database used in training, as well as the degree to which the training database is representative of the lesions that will be evaluated by MelaFind® in a practice setting.