In pursuing FDA approval of its MIST Therapy 5.0 wound treatment device, Celleration (Eden Prairie, Minnesota) took an unusual path. And Kevin Nickels, president and CEO of Celleration, called its De Novo clearance “a fascinating story.”

As background, Nickels said that most products in the wound care market are cleared through the 510(k) process, because of a low threshold to entry into an unfriendly market, one that Nickels described as “not especially appreciated by Medicare for reimbursement.”

“We decided that the way we’d really separate ourselves from the pack was to subject ourselves to a sham, double blind study,” he said. “This is something that people don’t do in wound care unless they absolutely have to,” he added, because of the magnitude of the clinical study the FDA requires.

The company in 2001 sought input on its proposed study from the Medicare and the FDA. Even though Celleration would not have to go through the more stringent premarket application (PMA) process, “we wanted their inputs on a study that they had been asking to have done, and nobody had really done in the device industry – a complete wound closure study.” Nickels described Celleration’s study as “basically a measuring of two cohorts [to determine] who got the highest incidence of [wound] closure over a period of time. In our case, we used a sham to mimic the spraying without the ultrasound.”

Fast forward about one year later.

The company approached the FDA seeking 510(k) clearance using as a predicate a water pik-type-technology that, like the MIST device, also sprayed saline. Celleration was rejected. The company responded to the FDA’s concerns, resubmitted its request and was again turned down.

According to Nickels, the FDA “did not want to clear our product with the predicate because they knew all it was doing was spraying saline, there was no therapy being applied” – even though the company was not seeking a healing application claim. The FDA knew this because Celleration had previously shared its plans for the therapeutic closure study, that “we were putting therapy in the body, we were creating a cellular level response.”

The FDA concluded that there was no safety issue for the MIST device, which would have pushed the company down the PMA path, yet also noted that the predicate device was not equivalent, so the 510(k) route was not appropriate, he explained.

So the company took the middle ground.

The FDA in June 2004 cleared Celleration’s device through the De Novo process, part of the FDA Modernization Act of 1997 intended to apply to low-risk products that have been classified as Class III devices and found not substantially equivalent to any identifiable predicate device.

“We were cleared to the market using a very unique pathway,” Nickels said. “I think we’re the 25th company that has ever used it. What came out of that process was a brand new, generic type of device which describes our product,” he said. “We now have successfully finished the trial, have successfully gotten peer-reviewed, we successfully submitted the results from the trial back to the agency in ‘05 and have now gotten our second FDA clearance” claiming that the product promotes wound healing.

“In hindsight, it was a painful [process],” Nickels acknowledged, but added that such a “participatory approach” ultimately was to the company’s advantage.

— Kim Urquhart