FDA imposes high hurdle for Cytori breast repair device

Cytori Therapeutics may need to spend $10 million more than anticipated to get clearance for its first product because of a stricter-than-anticipated regulation. Cytori had laid out $200 million in eight years on the device and was seeking "fast-track" clearance for the body-tissue repair device. But now it must take the slower regulatory path used for about one in every 10 experimental devices, Bloomberg reports.  

Stories like Cytori's may become more common because of new rules, Ira Loss, a senior health-policy analyst at Washington Analysis LLC, tells the news service. That's because the FDA may soon recommend new regulations to answer congressional criticism over product safety. Such tougher rules could mean that venture investors will shy away from investing in device start-ups, Loss explains.  Financiers may slash their investment or compel device makers to seek partners or buyouts, he adds.

Furthermore, the FDA may require more companies to conduct expensive clinical trials, compared with as little as $1 million under the current program for most approvals, according Linda Alexander, a medical-device industry consultant at Alquest.

Frustration has been brewing against the FDA among medical device start-ups. In fact, news of Cytori's woes comes on the heels of townhall meeting led by CDRH Director Jeffery Shuren, who assured a 400 audience members in Boston that his center will work will overhaul its procedures to speed innovation while protecting patient safety. And, as with previous townhall meetings, he heard plenty of criticism.

"We have not been clear about our expectations and we need to be,'' Shuren said, adding that regulators are committed to making "midcourse corrections,'' including seeking more clinical data before devices win clearance. Leaders of start-ups agreed with him that the agency wasn't always clear, telling him that FDA delays, mixed signals, and lack of predictability were causing confusion and threatening their businesses.

"To the investors in my company, it has become increasingly clear that prestated and prenegotiated rules of the game can now be capriciously and arbitrarily changed, and that good science no longer suffices for FDA clear ance,'' Eric Bornstein, chief science officer at Nomir Medical Technologies, told Shuren, as quoted by the Boston Globe. While the company and the agency had agreed on the structure, size, and measures of clinical studies for its specialized laser that kills bacteria in toenail fungus, company officials said, the FDA later changed the rules in a way that would require additional capital from its more than 100 angel investors.

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