Mela Sciences CEO: MelaFind rollout planned for early 2012

November 3, 2011 by Emily Greenhalgh

Dr. Joseph Gulfo, CEO of Mela Sciences (NSDQ:MELA), says the company plans to begin rolling out its MelaFind skin cancer detection system during the first quarter of 2012, after winning a hard-earned green-light from the FDA.

"I don't think we'll be 'selling,' in the classic sense of selling, for at least a year and a half," Gulfo told MassDevice. "Dermatologists want this system, so we don't need to 'sell' it.

"Since this is a new technology, our challenge will be incorporating it into the doctor's office," Gulfo said.

In what Mela Sciences is calling a "commercial development year," the company plans to place 200 MelaFind systems in the U.S. and 75 in Germany, working with doctors and patients to integrate the device into everyday care.

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The company doesn't plan to seek insurance reimbursement until a few years down the line, Gulfo told us, adding that the systems cost $7,500 (including placement and training fees) and a patient use fee of $50.

When it comes time to distribute MelaFind on a large scale, the company will take the reins itself, instead of putting its flagship product in the hands of distributors.

The path to U.S. approval was a long one for Mela Sciences. More than two years, two panel reviews and one citizen's petition after it signed on for a 6-month FDA review, the company won FDA clearance for the U.S. market yesterday.

It's been a good season for the company, which also won CE Mark approval in the European Union for MelaFind in September.

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