Medical device developer AirXpanders has received US clearance for its product used in breast reconstruction, driving its share price more than 13 per cent higher.
The company said it will accelerate the build-up of its US sales force and start to release the tissue expander in the US market now it has clearance from the US Food and Drug Administration.
AirXpanders' AeroForm Tissue Expander System is used by patients undergoing breast reconstruction following mastectomy.
"The market opportunity for AirXpanders in the US is significant, with the total addressable market worth more than $US800 million," chief executive Scott Dodson said on Thursday.
"As US mastectomy rates continue to rise and growing numbers of women undergo breast reconstruction, we are confident AeroForm will positively redefine the reconstruction process for women in the US."
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AirXpanders' tissue expander is activated by a handheld wireless controller that administers small amounts of carbon dioxide up to three times a day to gradually stretch the tissue to prepare for a breast implant.
AirXpanders says the needle-free preparation allows the patient to continue their daily activities.
AirXpanders' shares gained 15 cents, or 13.3 per cent, to a four week high of $1.275.
