Stymied by the FDA, Uromedica tries to plot a way forward

Suppose you’re a woman suffering from urinary incontinence, a rather unpleasant feeling. A surgeon implants a balloon device, allowing you to pee or to pee less. But the company who makes the device now wants to turn off the device for a week or two and then reactive it to prove to the Food and Drug Administration that it does indeed work.

Tough sell? Probably.

But that’s exactly what Uromedica Inc. of Plymouth, Minn. will propose to the FDA next month. The company is designing a “crossover” trial in which it will randomly shut down the balloon in some of the 100 or so women in the United States already implanted with the device for up to 14 days. Uromedica will then reinflate the balloon and see what happens to the urinary incontinence.

In a phone interview, CEO Tim Cook admits it won’t be easy to convince patients to sign on. But it’s preferable to the other alternative: conducting a new randomized trial that could consume another four years and $5 million to $8 million Uromedica doesn’t have.

Last month, Dr. Jeffrey Shuren, the new director of the agency’s Center for Devices and Radiological Health (CDRH), upheld the FDA’s decision not to approve Uromedical’s Pre-Market Approval (PMA) application for its Adjustable Continence Therapy (ACT) technology.  It was a bitter disappointment for Cook, who has been haggling with the FDA since 2000.

“I was surprised,” Cook said.

Well, yes and no. Yes, because Cook believes Uromedica met the clinical endpoints (goals) of the study the FDA now says is biased. And about 10,000 patients worldwide already carry the device with no apparent problems.

But even Cook says it would have been  difficult for Dr. Shuren to overrule his staff, especially when you consider Uromedica’s appeal was his first as head of CDRM.

Uromedica should serve as a sobering reminder to Minnesota’s medical device community that Dr. Shuren, for all of his good qualities, is just one man at the FDA. An important man, yes, but just one man at an agency understaffed, underfunded and under tremendous pressure to correct the FDA’s supposed lax oversight over medical devices.

At a recent town hall meeting in Minnesota hosted by Dr. Shuren, several members of the local medical device community praised the FDA official for listening to their concerns and suggestions. Listening, however, doesn’t necessarily mean anything will change. People might feel better venting to Dr. Shuren but the real test is action.

“We strongly believe Dr. Shuren when he says he wants the agency to be more transparent,” DuVal & Associates, a Minneapolis-based law firm, wrote to its clients. “It already has been as evidenced by yesterday’s meeting.  We think this trend will continue, but delivering bad news (more requirements and expectations, review and compliance oversight) in the light of day is still bad news.”

Even Cook doesn’t seem to harbor any ill feelings toward Dr. Shuren, noting the FDA official was attentive and thoughtful.

Still, Uromedica faces the same problem. If the FDA accepts its crossover study proposal, Cook says the company can complete it in about a year. If the FDA says no, then Uromedica will need to essentially start over and ask investors to fund a new randomized trial.

Given the dearth of venture capital, Cook sure hopes it’s the former. Thanks to international sales, Uromedica will break even this year and probably turn a small profit in 2011, he said. But the company has also had to reduce its costs severely, even cutting salaries multiple times.

Dr. Shuren may be a nice guy. But that’s not enough for struggling startups like Uromedica.