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AirXpanders XPAND Pivotal Trial Meets Primary Endpoint
31 / 08 / 2015
PALO ALTO, CA, United States, 25 August 2015: AirXpanders Ltd. (ASX:AXP) a medical device company focused on the design, manufacture, sale and distribution of the AeroForm® tissue expander, is pleased to report that its pivotal XPAND trial has met its primary endpoint in patients that have undergone a mastectomy.
The pivotal XPAND study - a randomised, controlled trial - included 150 patients across 17 sites in the US. The Company has now completed the clinical trial report, which complements and supports the preliminary results published in 2014. 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.
Jeffrey Ascherman, M.D., Chief of Plastic Surgery and Principal Investigator for the XPAND Trial from Columbia Presbyterian Medical Centre in New York, NY stated, “The AeroForm® has demonstrated that it can be used as effectively as saline expanders in the treatment of women who are going through two-stage reconstructive surgery following a mastectomy. I am looking forward to being able to offer this option to my patients and believe that this device has the potential to be the new gold standard for women who are recovering their shape following breast cancer surgery.”
The detailed final trial results will be presented at the prestigious American Society of Plastic Surgery Meeting on Sunday 18 October at 10:35am (local time) in Boston, Massachusetts.
Scott Dodson, President and CEO of AirXpanders, said: “We are encouraged by the results of our pivotal trial which are consistent with the previous trials that AirXpanders has conducted, and look forward to Dr. Ascherman’s presentation at the prestigious American Society of Plastic Surgery meeting.
“Women deserve a different option for two-stage breast reconstruction surgery than what has been offered to them for the past 50 years, and we believe AeroForm® can offer that alternative and provide a viable option for physicians and their patients.”
AeroForm® uses a controlled delivery of small amounts of carbon dioxide (CO2) to achieve the tissue expansion usually required for the placement of a permanent breast implant. It gives patients the
ability to control the expansion process themselves, continuous expansion without having to schedule as many inconvenient office visits, and its needle-free design allows for less painful tissue expansion at a significantly faster rate than is achieved using traditional expanders.
AirXpanders estimates that the current US market for tissue expanders is approximately 120,000 units per year with a total addressable US market of approximately 350,000 units per year. Subject to obtaining FDA 510(k) clearance, AirXpanders is planning for the commercial launch of AeroForm® in the US immediately afterwards.
For more information
AirXpanders Scott Dodson President & CEO
Tel: +1 (650)-390-9008
Email: sdodson@airxpanders.com
Investor and media relations Kyahn Williamson
Buchan Consulting Tel: +61 (3) 9866 4722
Email: kwilliamson@buchanwe.com.au
About AirXpanders
Founded in 2005, AirXpanders (ASX:AXP) is a medical device company focused on the design, manufacture, sale and distribution of its AeroForm® tissue expander used in patients undergoing breast reconstruction following mastectomy. AeroForm® uses controlled delivery of small amounts of gas (CO2) to achieve tissue expansion prior to the placement of a permanent breast implant.
AeroForm® successfully eliminates the need for needle-based expansion required by traditional saline tissue expanders and provides a faster and less painful breast reconstruction journey.
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. For more information, refer to the Company’s website at www.airxpanders.com. AirXpanders devices are not cleared or approved for use in the United States and are considered for investigational use only. AirXpanders is cleared for commercialization in Europe and in Australia.