logo-loader
viewAirXpanders

AirXpanders trial meets primary endpoint for mastectomy patients

au_united_states350_55dbefc09d214.jpg

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.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

Quick facts: AirXpanders

Price: - -

ASX:AXP
Market: ASX
Market Cap: -
Follow

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

FOR OUR FULL DISCLAIMER CLICK HERE

Watch

Bardoc Gold reels in $24 million in strongly supported "transformational"...

Bardoc Gold Ltd (ASX:BDC) has received a strong indication of support for its transition from gold explorer to developer by raising $24 million in a share placement. Chief executive officer Robert Ryan told Proactive that there had been a high level of demand from institutional investors in...

1 hour, 7 minutes ago

2 min read