AirXpanders (ASX:AXP) has rolled out its AeroForm Tissue Expander System in more than 100 medical institutions and health systems across the U.S.
AeroForm Tissue Expander offers a needle-free alternative for women who choose reconstructive surgery following a mastectomy.
The device is activated by a handheld wireless controller that administers small amounts of carbon dioxide (CO2) up to three times a day, to gradually stretch the tissue to prepare for a breast implant.
With the push of a button from the controller, a pre-programmed amount of CO2 is delivered in seconds, allowing the patient to continue with her daily activities while preparing for reconstruction.
AeroForm was granted de novo clearance by the U.S. Food and Drug Administration (FDA) in December 2016.
For decades, women opting for two-stage reconstruction have had to undergo a cumbersome and uncomfortable process to expand their tissue prior to reconstructive surgery.
AirXpanders’ device is expected to improve patients’ experience and empower them to take back control of their time and bodies after often long journeys through breast cancer.
Studies show that one in eight women in the U.S. will develop breast cancer, with mastectomy being the most frequently performed treatment (about 250,000 per annum).
The market opportunity for AirXpanders in the U.S. is significant, with the total addressable market worth more than US$800 million.
The company’s vision is to be the global leader in reconstructive surgery products and the standard of care in two-stage breast reconstruction.