AirXpanders Inc. (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 who have undergone a mastectomy.
The pivotal XPAND study, a randomized, controlled trial, included 150 patients across 17 sites in the United States. The Company has now completed the clinical trial report, which complements and supports the preliminary results published in 2014. The subjects in the study achieved successful exchange to a permanent implant with the same safety profile as saline tissue expanders.
The results will be submitted to the U.S. 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 Center in New York, stated, "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 Surgeons Meeting on Sunday, October 18 at 10:35 a.m. ET in Boston, Massachusetts.
"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 Surgeons Meeting," said Scott Dodson, president and CEO of AirXpanders Inc.
"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," said Dodson.
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, enabling 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 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. Subject to obtaining FDA 510(k) clearance, AirXpanders is planning for the commercial launch of AeroForm in the U.S. immediately afterwards.