AirXpanders (ASX:AXP) said today that it has commitments from investors in a private placement to raise A$45 million, or $34 million USD. The Palo Alto, Calif.-based company said that its investors committed to subscribe for 16.3 million shares of common stock at ¢70 apiece.
The company plans to use the funds to bring its breast tissue expansion device to the U.S., including building inventory for the U.S. market and hiring a sales force. AirXpanders also said it plans to complete its expansion of commercial manufacturing capacity in Costa Rica.
“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,” president & CEO Scott Dodson said in prepared remarks. “It’s an exciting time for AirXpanders, and we thank our existing and new investors for their support.”
In December, AirXpanders won de novo clearance from the FDA for its tissue expander system. The AeroForm system is designed to use in past-mastectomy breast reconstructions to expand and stretch the skin prior to a permanent breast implant.
In a conversation with MassDevice.com this month, Dr. Tracey Stokes, a plastic surgeon based in Fort Lauderdale, Fla., told us that the Aeroform system is a welcome alternative to the traditional saline injection procedures that her patients undergo.
Over 2 years ago, she agreed to be the principal investigator in a pair of clinical trials of the needle-less AeroForm device.
In a 150-patient U.S. study published in Plastic & Reconstructive Surgery, comparing the AeroForm device and traditional saline expanders, the AeroForm group completed tissue expansion in 21 days, compared to 46 days for the control group. The AeroForm cohort also completed full reconstruction a month sooner than their counterparts in the control arm.