AirXpanders is a medical device company focused on the design, manufacture, sale and distribution of its AeroForm® tissue expander, which is approved for sale in Europe and Australia. The company is expecting results from its pivotal trial shortly and anticipates that AeroForm will be reviewed for clearance by the U.S. Food and Drug Administration (FDA) this year. Subject to receiving marketing clearance, AirXpanders is aiming to commercialize AeroForm in the U.S. in early 2016.
Tissue expanders are used in breast reconstruction procedures following mastectomy to expand and stretch the skin and underlying muscle prior to the placement of a permanent breast implant.
It is anticipated that AXP will list on the ASX during June 2015.