AirXpanders said today that it has received FDA clearance to market a smooth shell version of its AeroForm Tissue Expander.
The Palo Alto, Calif.–based company makes the AeroForm device for post-mastectomy breast reconstruction. It 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.
“We are very pleased to receive FDA 510(k) clearance for the smooth shell AeroForm tissue expander,” said AirXpanders president & CEO Frank Grillo in a news release. “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 market release in the U.S., and we have already submitted our regulatory application for CE mark approval.”
In May, the company announced it has retained Cowen as an independent financial advisor to assist in exploring financial and strategic alternatives, including a possible capital raise, to enhance stockholder value and enable the company to continue serving patients and physicians.
“As AirXpanders explores these alternatives, it will also evaluate U.S. launch plans and timing for the AeroForm Smooth products,” the company said in the statement.
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