PALO ALTO, Calif., Nov. 13, 2015 /PRNewswire/ -- AirXpanders Inc. (ASX:AXP), a medical device company focused on the design, manufacture, sale and distribution of the AeroForm® tissue expander, has received advice from the U.S. Food and Drug Administration regarding its 510(k) submission and will now proceed with a de novo submission. AirXpanders will compile all of the information required for the de novo submission and submit the application within a few weeks. Dialogue between the Company and the FDA will be ongoing, with a formal review of the application expected in the second quarter of 2016.
AirXpanders President and Chief Executive Officer, Scott Dodson said, "The de novo process is used when there is no identical predicate device in the same medical field upon which to make comparisons. With the clearance of the AeroForm System through the de novo process as a low to moderate risk device, AeroForm would become its own predicate for future submissions."
The 510(k) process allows for a 90 day review period while the de novo process has a 120 day review cycle.
The de novo application details the results of the existing FDA-approved XPAND pivotal trial of 150 patients which successfully met its primary endpoint of demonstrating that the AeroForm tissue expander is a safe and effective method of expansion as an alternative to saline tissue expansion, to successfully expand the tissue and exchange to permanent breast implants.
Data from this trial was presented in October 2015 at the American Society of Plastic Surgery in Boston, Massachusetts. This trial, in addition to the Company's three successful prospective trials conducted in Australia, will serve as the basis for seeking FDA clearance for the AeroForm tissue expander.
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.
SOURCE AirXpanders Inc.