AirXpanders (ASX:AXP) said yesterday that it submitted a special 510(k) application with the FDA seeking approval for a smooth shell version of its AeroForm tissue expander system.
The Palo Alto-based company’s AeroForm tissue expander is intended for post-mastectomy breast reconstruction. The device is designed to expand and stretch the skin and underlying muscle prior to a permanent breast implant using small amounts of CO2 up to three times a day.
“Following in the wake of our successful launch of the AeroForm tissue expander system, we are excited to bring a smooth version to market. The plastic surgery community has embraced the textured version of our tissue expander, and they have also been asking us to provide a smooth, untextured version of AeroForm. We are looking forward to introducing our smooth expanders and offering our unique products in both smooth and textured versions,” prez & CEO Frank Grillo said in a press release.
AirXpanders added that it plans to seek approval for the smooth shelled version of its AeroForm device with Australia’s therapeutic goods administration.
Earlier this month, AirXpanders said that it engaged an independent financial advisor as it begins to explore ‘strategic alternatives.’