|AeroForm device--Courtesy of AirXpanders|
Australian device company AirXpanders ($AXP) has raised AU$20 million (US$15 million) in a private placement in anticipation of an FDA clearance--and subsequent U.S. launch in the first quarter of 2017--for its novel tissue expansion tech for women undergoing breast reconstruction after mastectomy.
The financing is slated to aid market growth of its AeroForm in Australia, complete a manufacturing move to Costa Rica and prepare for the U.S. launch with investments in sales and marketing. The device is being reviewed by the FDA under the de novo pathway reserved for low-risk devices with a decision anticipated by the company in the next few weeks; it already has a CE mark in Europe.
"We continue to successfully execute our Australian growth strategy while investing in preparation for the U.S. launch of our AeroForm technology," said AirXpanders CEO Scott Dodson in a statement. "We welcome the strong support from both existing and new institutional shareholders. This additional capital strengthens our balance sheet as we prepare for commercial launch in the U.S., pending receipt of FDA clearance, and will help us complete the automation and transfer of our manufacturing to Costa Rica and continue our growth in the Australian market, where we have achieved tremendous success since launching in July last year."
In its most recent pivotal data from a 150-patient trial on AeroForm presented last fall, it met the primary endpoint showing that the tissue expander is a noninferior method of expansion as compared to traditional saline tissue expansion. It reduced tissue expansion to 21 days from 46 days for the saline group, with 98% of patients reporting that the device was easy and convenient to use.
"The AeroForm has provided the patients in this trial with a faster and more convenient form of tissue expansion versus saline devices," said the trial's principal investigator, Dr. Jeffrey Ascherman, chief of the division of plastic surgery at Columbia University, in a statement at the time. "A hidden benefit of this device is the fact that the patient can play an active role in recovering her body after breast cancer. My patients have thoroughly enjoyed this role and I am confident that this will appeal to many women across the U.S. and around the world when widely available."
AirXpanders shares ticked up on the financing news, but its market cap remains around $185 million.
- here is the release