AeroForm tissue expander system receives 510(k)September 6, 2019
AirXpanders, Inc has received US FDA 510(k) clearance to market a smooth shell version of the AeroForm Tissue Expander.
“We are very pleased to receive FDA 510(k) clearance for the smooth shell AeroForm tissue expander,” said Frank Grillo, president and CEO of AirXpanders, in a statement.
“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. This clearance enables the market release in the US, and we have already submitted our regulatory application for CE mark approval,” he added.
Previously, the company announced it has retained Cowen as an independent financial advisor to assist in exploring financial and strategic alternatives that could enhance stockholder value and enable the company to continue serving patients and physicians. As AirXpanders explores these alternative, it will also evaluate US launch plans and timing for the AeroForm Smooth products.