AirXpanders Inc. will start a clinical study of its breast tissue expansion device in mastectomy patients — and seek additional financing — after the Food and Drug Administration on Monday granted a key exemption.
The Palo Alto company said it will seek $7 million-$10 million to help pay for clinical and commercial work for AeroForm, its device for women undergoing breast reconstruction. That work includes regulatory clearance in the United States and Europe, increased manufacturing and limited commercialization in Europe and Australia.
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