For AirXpanders, a switch from 510(k) to de novo was no big deal

Scott Dodson didn’t worry when the FDA requested a call.

Dodson is CEO of AirXpanders, a Palo Alto, Calif.-based company that had made a 510(k) submission for its AeroForm tissue expander, a device designed for post-mastectomy breast reconstructions that uses a gradual patient-controlled release of compressed gas to expand and stretch the skin/underlying muscle before a permanent breast implant.

With that in mind, the FDA wanting to speak with AirXpanders’ executives was initially seen as a positive, Dodson said. However, regulators explained over the phone, then by fax, that they saw AeroForm more appropriately as a de novo submission, a designation for low- to moderate-risk devices that don’t have a “substantially equivalent predecessor” device already on the market.

Translated: The FDA’s recommendations meant some fast changes were in order.

Dodson and his team quickly decided to adapt to the new requirements, despite the longer time frame. A 510(k) submission has a 90-day clock, for example, while de novo applications have a 120 day clock (both of which can stop and then restart as regulators seek more information or have questions).

Dodson said reworking the application to a de novo format took about 2½ weeks to complete and then resubmit. The de novo route has clear advantages, he added, a process he described as being somewhat more free flowing than the 510(k).

“During the de novo process, from what the FDA explains to us, if there are questions, the FDA will pick up the phone and call us and request a call to help clarify the process as well,” Dodson said.

AirXpanders has a healthy body of data that easily supports either approval route, Dodson added. Some of that comes from past clinical testing, as well as data generated, in part, followed by a CE Mark in 2011 in Europe and Australian regulatory approval in 2013.

“For our company, it was very doable, because we have such as strong, clinical dataset – not only with our IDE trial but also with trials we have completed internationally as well,” Dodson said.

While some companies struggle when the FDA asks for application changes or recommends a new approval pathway, Dodson said that AirXpanders execs found the process to be reasonable. At the same time, he acknowledged some of the uncertainties in the regulatory process.

“Whenever you get direct feedback from the agency it always gives you a reason to pause, because you are not always quite sure what the feedback is going to be,” Dodson said.

“Some of these applications can go 1 way or another. The FDA’s logic here was really not unreasonable at all. We chose to go down the 510(k) pathway because we felt there were reasonable predicates in the space that does what our device does. But there are some technological differences in how our device does [what it does]. One could make the argument either way and we respect the FDA’s opinion.

“In my 25 years in [the medical device industry], when the FDA provides you with some guidance and it is reasonable guidance you are probably well heeded to adhere to that,” Dodson added.

Dodson doesn’t has a long history in medical devices. He spent more than 18 years with Boston Scientific (NYSE:BSX) in various executive roles (1999-2004), working in sales, marketing and business development, and for divisions including gastroenterology and women’s health.

AirXpanders launched in 2006, and now employs 50 people around the globe. The company went public in Australia in 2014 and has commercialized AeroForm there since then.

As Dodson sees it, the company is still in its build-up phase. As it works with the FDA, it continues scale up its manufacturing, and flesh out its sales and marketing capacity while waiting for the O.K. to start U.S. commercialization.

While AirXpanders is not yet profitable, it has been good with is funding. There had only been $31.5 million in venture funding before the company’s Australian IPO, which brought in another $27.5 million.

Australian sales, meanwhile, are helping to generate data and valuable information.

“Due to the similarities of the Australian marketplace and the U.S. marketplace, we’re learning a lot that can be directly leveraged in the U.S. marketplace when we commercialize here,” Dodson said.

If all goes well, U.S. commercial sales could launch by mid-2016, Dodson said.

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