Australia’s AirXpanders, which makes a wireless breast tissue expander, has picked up AU$45 million ($34 million) in a private placement. The funding will propel the company’s expansion into the U.S. market.
AirXpanders’ AeroForm system includes an expander, which is implanted behind the chest muscle, and a hand-held wireless controller. At her convenience, a patient uses the controller to release puffs of compressed carbon dioxide into the device. The system gradually expands breast tissue for patients who choose to undergo breast reconstruction.
The system earned de novo clearance from the FDA in December and is a needle-free, at-home alternative to saline implants for breast tissue expansion. Patients with saline implants must make multiple visits to their physician’s office for saline injections.
It cuts down on the total time taken to expand, as well as the time patients spend traveling to and waiting at their physician’s office.
"Following receipt of FDA de novo clearance in December 2016, we are now moving ahead with the commercial launch of AeroForm in the United States. This raise provides us with the capital to expedite the build out of our U.S. sales force, and increase our manufacturing capacity to ensure we have the inventory to meet the expected demand for the product," said CEO Scott Dodson, in a statement.
Broken into two tranches, the first tranche of about $19 million will be issued early next month. Anticipating clearance, the company previously raised $15 million in a private placement last summer.