Medical device company AirXpanders
(ASX:AIX) says the first commercial surgical procedure using its Aeroform technology has taken place at a hospital in San Jose, California.
The company says this procedure was performed by a plastic surgeon, and occurred after the US FDA granted it de novo marketing authorisation on 21 December 2016.
AirXpanders is the maker of Aeroform, which is a needle-free, wireless tissue expander system for patients who choose to have breast reconstruction surgery following a mastectomy, and it has been available in Australia since it was approved for sale in late-2014.
The company is planning for Aeroform to have a targeted market release in the US, with a focus on key high volume academic and community hospitals.
AirXpanders reported a net loss of $11.9 million at 30 June 2016.