The controlled, open-label, prospective, pivotal and randomized study is designed to assess the safety and efficacy of the company’s AeroForm breast tissue expansion device in mastectomy patients undergoing breast reconstruction.

AeroForm tissue expander system features a technologically advanced self-contained tissue expander and a small hand-held wireless remote control.

The system uses compressed carbon dioxide and releases it through a small internal valve to fill the expander which aids in stretching the skin and the muscle of the chest wall so a permanent breast implant can be inserted.

AirXpanders president and CEO Scott Dodson said they are collecting the data that will be submitted to the FDA in support of their 510(k) application.