Medical device company AirXpanders (ASX:AXP) which recently listed on the Australian Securities Exchange is making progress with its needle-free, patient-controlled tissue expander called AeroForm for breast reconstruction procedures following a mastectomy.
The Palo Alto based company's pivotal XPAND study, a randomised, controlled trial for patients that have undergone a mastectomy, included 150 patients across 17 sites in the U.S.
The subjects in the study arm achieved successful exchange to a permanent implant with the same safety profile as saline tissue expanders.
The results will be submitted to the US Food and Drug Administration (FDA) as part of the Company’s 510(k) dossier which is planned to be delivered to the FDA shortly.
The company reported a cash balance of US$28 million for the June quarter following its oversubscribed ASX raising and listing of shares in June 2015 at $0.50 each.
It raised around $36.5 million in an offer of CHESS Depositary Interests (CDIs) to local and international investors.
The AeroForm device operates with a small reservoir of CO2 (carbon dioxide) gas that is stored within the implant itself.
The patient uses a hand-held remote control to pass over the breast. At the press of a button, the control communicates with the implant and a small amount of CO2 goes into the expander.
AirXpanders says the AeroForm product will transform current breast reconstruction methods, making it much faster, less intimidating and less painful.
AeroForm® has CE Mark and TGA approval and is covered by the Australian reimbursement regime. To date, AeroForm® has been successfully implanted more than 500 times in women in Australia and the United States.
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