AirXpanders, a medical device company focused on the design, manufacture, sale and distribution of the AeroForm tissue expander, announces it has filed its 510(k) submission with the U.S. Food and Drug Administration (FDA).
AirXpanders CEO Scott Dodson said, "I am delighted to announce that AirXpanders has submitted a 510(k) notification to the FDA for the AeroForm tissue expander.
This is a very important milestone for the Company as we continue to commercialize our device in Australia and prepare for entry into the U.S. market. I believe AirXpanders is well-positioned to capitalize on the significant opportunities that lie ahead for the Company."
In August 2015, AirXpanders announced its pivotal XPAND study had met its primary endpoint in patients who have undergone a mastectomy.
The subjects in the study arm achieved successful exchange to a permanent implant with the equivalent safety profile as saline tissue expanders. The detailed final trial results have been submitted to the FDA as part of the Company’s 510(k) filing, and will be presented at the American Society of Plastic Surgeons Meeting on Sunday, October 18 in Boston, Massachusetts.
AirXpanders estimates that the current U.S. market for tissue expanders is approximately 120,000 units per year, with a total addressable U.S. market of approximately 350,000 units per year.
The Company believes its commercialization efforts will benefit from existing reimbursement covering breast reconstruction procedures in the U.S., as well as federal laws such as the Women’s Health and Cancer Rights Act of 1998, which mandates reimbursement coverage for reconstructive procedures with a diagnosis of breast cancer.
The AeroForm device uses a controlled delivery of small amounts of carbon dioxide (CO2¬¬) to achieve the tissue expansion usually required for the placement of a permanent breast implant.
It gives patients the ability to control the expansion process themselves, and its needle-free design allows for less painful tissue expansion at a significantly faster rate, with fewer visits to their physician, than is achieved using traditional expanders.