MELA Sciences Inc MELA Sciences is a medical device company

MELA Sciences Inc MELA Sciences is a 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 indeterminate pigmented skin lesions. The FDA has approved MelaFind for use in the U.S. It has received the CE Mark for use in the European Union.

MELA Sciences was incorporated in 1989 as Electro-Optical Sciences, Inc. The Company’s initial projects involved research and development of advanced technologies for remote sensing and image analysis methods for targets of interest to the Department of Defense. Support for this work came from the Office of Naval Research, the Ballistic Missile Defense Organization and the Defense Advanced Research Projects Agency (DARPA).  Then, during the mid-1990s, the Company collaborated with melanoma experts from New York University to apply its expertise in signal processing “machine vision” technology to medicine and develop new methods to differentiate early melanomas from histologically benign, yet atypical, pigmented skin lesions.

The Company also engaged in several other machine vision development efforts, including DIFOTI, a system for detecting dental cavities without x-rays, developed with support from the National Institute of Dental Research (NIH/NDR), as well as SkinSurf, a patented non-contact device designed to help researchers measure skin wrinkles.

Grants from the US Air Force Phillips Laboratory and the National Cancer Institute (NIH/NCI) supported the development of a multi-spectral lesion imaging (SLIM) instrument, the predecessor of MelaFind®, designed to help identify clinically atypical pigmented skin lesions to be considered for biopsy to rule out melanoma.

The Company began doing business as MELA Sciences in February 2010 and formally changed its name to MELA Sciences, Inc. in May 2010.
http://melasciences.com

Melanoma is the deadliest form of skin cancer, responsible for approximately 75% of skin cancer fatalities. There are an estimated 130,000 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 (ACS).

A National Cancer Institute report published in the July 10, 2008 online edition of the Journal of Investigative Dermatology indicates that the annual incidence of melanoma among young adult Caucasian women rose 50% between 1980 and 2004. Melanoma is the most common cancer in women aged 25 to 29 and the number-one cancer killer of women ages 30 to 35. Although no cure is currently available for advanced-stage melanoma, melanoma is virtually 100% curable if caught early.

If diagnosed early, a dermatologist removes melanoma at a cost of approximately $1,800 per patient. Treatment costs soar as the melanoma advances, rising to $170,000 per patient at the later stages and accounting for 90% of the overall melanoma treatment costs.

Because early detection is critical to survival, the American Cancer Society recommends that all Americans over the age of 20 undergo complete skin examinations during their periodic health check-ups. The individuals in the US with dysplastic nevi, a type of pigmented skin lesion associated with an increased risk of melanoma, warrant more frequent observation.

Melanomas are mainly diagnosed by dermatologists using visual clinical evaluation. Dermatologists assess clinically atypical pigmented skin lesions using the “ABCDEPRU” criteria: Asymmetry, Border irregularity, Color variegation, Diameter greater than 6 mm, Evolving – a change in “ABCD” over time,Patient’s Concern, Regression, and Ugly Duckling. This assessment is subjective and results in missed melanomas as well as a highly variable ratio of benign lesions biopsied to melanomas detected; the biopsy ratio is as high as 50 to 1 for dermatologists.

MELA Sciences designed MelaFind® to assist in the evaluation of clinically atypical pigmented skin lesions that have one or more clinical or historical characteristics of melanoma when a dermatologist chooses to obtain additional information before making a final decision to biopsy to rule out melanoma.

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.



Proprietary Database of Pigmented Skin Lesions. The database includes in vivo multi-spectral data and corresponding histological results of over 10,000 biopsied lesions from over 7,000 patients at 40 clinical study sites. MELA Sciences believes this is the largest such database in the US and a substantial barrier to competition.

MelaFind® Pivotal Trial Results.  The Company conducted numerous studies of the MelaFind®system, including the landmark MelaFind® pivotal trial, the largest prospective clinical study ever conducted in melanoma detection. For all subgroups analyzed in the pivotal study, the sensitivity of MelaFind® was greater than 95% (95% lower confidence bound) and its specificity was statistically significantly higher than that of study clinicians.  For more information about MelaFind® clinical studies, visit www.melafind.com.

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.

MelaFind® Hand-Held Cross Section

Light of 10 varying wavelengths shines from MelaFind® to acquire data from a lession.

MELA Sciences to Participate in Upcoming 12th Annual Needham Healthcare Conference

IRVINGTON, Apr 15, 2013 (GLOBE NEWSWIRE via COMTEX) -- MELA Sciences, Inc. (Nasdaq:MELA), the medical device company that has developed and is commercizlizing MelaFind, today announced that it will be participating in the upcoming Needham Growth Conference, being held April 30 - May 1, 2013 at the Westin Grand Central Hotel in New York.

Joseph V. Gulfo, MD, MELA Sciences President and CEO will be presenting at the conference on Wednesday, May 1 at 12:50pm ET.

To access a live webcast of the Needham presentation, visit the investor relations section of www.melasciences.com. A replay will be available on the company's website for two weeks following the presentation.

About MELA Sciences, Inc.

MELA Sciences 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, visit www.melasciences.com.

MELA Sciences Inc MELA MELA Sciences to Participate in Upcoming 12th Annual Needham Healthcare Conference
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," "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 or becomes commercially viable. 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.

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