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MELA Sciences shares soar after flagship MelaFind product receives PMA approval

MELA Sciences shares soar after flagship MelaFind product receives PMA approval

MELA Sciences (NASDAQ:MELA) announced Monday its flagship MelaFind product, designed to test skin lesions in association with melanoma, has received pre-market approval (PMA) from the US FDA, sending its shares up over 60%.

As of 10:17 am EDT, MELA shares rose 61.2% to $5.13. Before the bell, the skin cancer-focused medical device manufacturing company saw its shares rise over 90%.

MelaFind is a medical device intended to obtain additional information on an atypical cutaneous pigmented skin lesion, in association with melanoma, the deadliest form of skin cancer.

The device is specifically intended to be used by trained physicians, namely dermatologists, in combination with a biopsy of the lesion.

Dr. Darrell S. Rigel, Clinical Professor of Dermatology at New York University said: "MelaFind has the potential to provide dermatologists with significantly more information about indeterminate pigmented skin lesions to help us when deciding on which lesions to biopsy to detect melanoma as early as possible."

"While there have been incremental improvements in imaging tools for melanoma detection, we still primarily rely on our judgment based on a visual examination to select the lesions to biopsy; data show that this is often not enough."

Responsible for about 75% of all skin cancer-related deaths, melanoma is estimated to kill approximately 9,000 Americans in 2011 alone. If detected early, the disease is virtually completely curable. However, patients with stage IV melanoma often succumb to the disease within six to ten months.

Earlier this month, MELA received a CE mark for MelaFind, meaning that it has reached consumer standards across all 27 nations of the European Union, allowing for its sale in the EU.

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