Uromedica, which develops urinary incontinence treatments, will find out in as soon as a few weeks if its medical device for men is ready for U.S. Food and Drug Administration approval application.
The Minnesota medical device company submitted fresh data to the FDA that, if accepted, would be the basis for a premarket approval (PMA) application, CEO Tim Cook said. Uromedica sent the data, which included a clinical analysis of more than 120 men, to the FDA in November. The company hopes to hear back from the agency by the end of January.
The application — while far from the big breakthrough — would be a significant win for the company. The company’s devices are available worldwide, but the FDA in 2010 rejected its PMA application for its female incontinence device, ACT, and the company’s approval efforts in the United States have stalled.
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If the FDA accepts the data submitted for the male device, then Uromedica has several big decisions on its plate. At that point, Cook said the company would go ahead with a PMA for its male device, which would likely be completed in the second half of the year. It would also consider resubmitting for its female incontinence treatment and raising additional private capital in order to complete new studies.
The market for male continence products that Cook aims to go after in the U.S. is roughly $200 million, while the one for female incontinence is double the size.
Uromedica has raised $24 million since 1997. The earliest the company could be in the United States with its male device would be 2013.
A go-ahead from the FDA would also be a nice start after a strong 2011. Cook said the company is “right at breakeven.” This year he expects international sales to increase by 33 percent and is projecting profitability this year because the company has won reimbursement approval from the French government for ProACT. Last year, the company implanted more than 1,000 devices taking the total number of devices implanted to more than 10,000.
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Uromedica will also expand into new markets this year including Russia and Poland, Cook said. Cook is projecting revenue from both countries in 2012.