AirXpanders Submits FDA 510(k) Filing for AeroForm®
PALO ALTO, Calif., Sept. 1, 2015 /PRNewswire/ -- AirXpanders Inc. (ASX:AXP), a medical device company focused on the design, manufacture, sale and distribution of the AeroForm® tissue expander, announces it has filed its 510(k) submission with the U.S. Food and Drug Administration (FDA).
AirXpanders CEO Scott Dodson said, "I am delighted to announce that AirXpanders has submitted a 510(k) notification to the FDA for the AeroForm tissue expander. This is a very important milestone for the Company as we continue to commercialize our device in Australia and prepare for entry into the U.S. market. I believe AirXpanders is well-positioned to capitalize on the significant opportunities that lie ahead for the Company."
In August 2015, AirXpanders announced its pivotal XPAND study had met its primary endpoint in patients who have undergone a mastectomy. The subjects in the study arm achieved successful exchange to a permanent implant with the equivalent safety profile as saline tissue expanders. The detailed final trial results have been submitted to the FDA as part of the Company's 510(k) filing, and will be presented at the American Society of Plastic Surgeons Meeting on Sunday, October 18 in Boston, Massachusetts.
AirXpanders estimates that the current U.S. market for tissue expanders is approximately 120,000 units per year, with a total addressable U.S. market of approximately 350,000 units per year. The Company believes its commercialization efforts will benefit from existing reimbursement covering breast reconstruction procedures in the U.S., as well as federal laws such as the Women's Health and Cancer Rights Act of 1998, which mandates reimbursement coverage for reconstructive procedures with a diagnosis of breast cancer.
The AeroForm device 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, and its needle-free design allows for less painful tissue expansion at a significantly faster rate, with fewer visits to their physician, than is achieved using traditional expanders.
About AirXpanders
AirXpanders Inc. (www.airxpanders.com) is a tissue expansion company focused on the area of breast reconstruction. By employing a revolutionary patient-controlled expander, activated by a wireless remote control, the often painful process of reclaiming one's body after cancer can potentially be eased with this needle-free technology. This technology is easy to use and may enable the patient to proceed to a permanent implant much faster than the current standard of care. AirXpanders is a publically listed company on the Australian Stock Exchange under the symbol AXP and is backed by Vivo Ventures, GBS Venture Partners, Prolog Ventures, Heron Capital, Shalon Ventures, Correlation Ventures, Western Technology Investments and a number of leading investment firms in Australia, Hong Kong and Singapore. 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.
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SOURCE AirXpanders Inc.
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