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.
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.
The FDA green light marks an end to the years-long plight that made Mela Sciences a poster child for charges of unpredictability at the FDA, culminating in a Progressive Policy Institute report, "Is the FDA Strangling Innovation?"
In June, Gulfo told MassDevice that the company was an unintended victim of the push for reforms at the FDA’s Center for Devices & Radiological Health.