AirXpanders wins US FDA 510(k) clearance for smooth shell version of the AeroForm Tissue Expander system.
M2 EQUITYBITES-July 15, 2019-AirXpanders wins US FDA 510(k) clearance for smooth shell version of the AeroForm Tissue Expander system
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Medical device company AirXpanders Inc (ASX:AXP) reported on Friday the receipt of marketing approval from the US Food and Drug Administration (FDA) 510(k) for the smooth shell version of the AeroForm Tissue Expander.
The company's AeroForm Tissue Expander System is used in patients undergoing two- stage breast reconstruction following mastectomy. AeroForm was granted US FDA de novo marketing authorization in 2016, subsequent US market clearance in 2017, first CE mark in Europe in 2012 and is currently licensed for sale in Australia.
Additionally, the company will evaluate the US launch plans and the timing for the AeroForm Smooth products.
In conjunction, the company has retained Cowen as an independent financial advisor to assist in exploring financial and strategic alternatives that could enhance stockholder value as well as to enable to continue serving patients and physicians.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Jul 15, 2019|
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