AirXpanders’ breast tissue expander scores de novo clearance

The AeroForm tissue expander allows patients to control their breast tissue expansion ahead of reconstruction.(AirXpanders)

The FDA cleared AirXpanders’ wireless tissue expander system, which provides patients who choose to undergo breast reconstruction with an at-home, needle-free alternative to saline breast expanders.

The AeroForm system comprises an expander that is implanted behind the chest muscle and a hand-held, wireless controller. A patient uses the controller to release compressed carbon dioxide into the device, which gradually expands the breast tissue to make room for a breast implant. Patients may administer doses of carbon dioxide daily, up to three times a day. Meanwhile, patients who receive traditional saline expanders must make multiple visits to their doctor’s office for expansion via saline injection.

While AeroForm doses are small—a “small 10cc puff” each—they add up over time and can get a patient fully expanded within 17 days, said AirXpanders CEO Scott Dodson. A saline device, Dodson said, can take upward of three months to reach the same state.

Aside from reducing the total time required to expand, the system also cuts down on the time patients spend traveling to and waiting at their surgeon’s office. Its needle-free nature is also a big draw, as multiple painful saline injections over the course of months could be a barrier to reconstructive surgery for some patients, according to the company.

“Reconstruction is one of the last phases of a long and sometimes taxing journey for women who are treated for breast cancer," said Dr. Jeffrey Ascherman, principal investigator for AirXpanders’ U.S. XPAND trial, in a statement. "They have lost time and control, and are eager to get back to their lives. Needle-free, patient-guided expansion could be a suitable option for many women undergoing the reconstruction process."

AeroForm earned a CE mark in 2012 and is licensed for sale in Australia, where it scored approval in 2014. The company is already preparing for its U.S. launch, which will take place in selected academic and community hospitals that took part in the pivotal and continued access trials of the device. In June, the company picked up $15 million in a private placement in anticipation of U.S. clearance and market launch.

“The market opportunity for AirXpanders in the U.S. is significant, with the total addressable market worth more than US$800 million,” Dodson said in the statement. "As U.S. mastectomy rates continue to rise and growing numbers of women undergo breast reconstruction, we are confident AeroForm will positively redefine the reconstruction process for women in the U.S."