PALO ALTO, Calif., Dec. 8, 2014 /PRNewswire/ -- AirXpanders, Inc., a company developing novel technology for women undergoing tissue expansion for breast reconstruction following a mastectomy, today announced the first commercial sale of its AeroForm® tissue expander in Australia.
The Australian Therapeutic Goods Administration (TGA) approved AeroForm, a needle-free, patient-controlled tissue expansion system, in November 2013. Following three open-labeled, prospective clinical trials, the TGA awarded AirXpanders reimbursement on the Australian Governmental Prostheses List effective Dec. 5, 2014. The first commercial sale of the device occurred on that date at The Mount Hospital in Perth, Western Australia.
"We are thrilled to offer the women of Australia a needle-free, patient-controlled option for recovering their shape following mastectomy," said Scott Dodson, president and chief executive officer of AirXpanders. "We have demonstrated a faster, more convenient option for women seeking reconstruction after breast cancer surgery, and our results have been consistent around the world. We will continue to offer our technology in a limited market release with five Australian surgeons until May 2015, when we will conduct a full market release for the entire country."
"Now that the AeroForm is commercially available and reimbursed in Australia, I anticipate that many more women will opt against traditional saline expansion methods," said Dr. Tony Connell, FRACS, plastic surgeon at The Mount Hospital. "After three years of using the AeroForm and over 200 units placed in a clinical setting, my patients have come to expect this technology and ask for it by name. It has proven itself reliable, easy to use and my patients appreciate the opportunity to play an active role in recovering their bodies after cancer. What's more, patients do not have to return to the office as frequently and can fill from home if they choose."
One in nine Australian women will develop breast cancer during their lives. The most common method of breast reconstruction involves tissue expansion followed by the placement of a breast implant. Reconstruction rates continue to climb as more women are opting for prophylactic mastectomies once cancer has been diagnosed on one side. With the release of the AeroForm, women finally have access to the first technological advancement in tissue expansion in over 50 years.
AirXpanders, Inc. is a medical device company focused on the area of tissue expansion. The AeroForm device is specifically designed for breast reconstruction and is the first product developed by AirXpanders. By employing a revolutionary patient-controlled expander, activated by a wireless remote control, the often painful process of recovering one's feminine shape after cancer can be improved with this needle-free technology that is easy to use and may enable the patient to proceed to a permanent implant much faster than the current standard of care. AirXpanders plans to develop tissue expanders that can be used in other therapeutic areas, such as burns, pediatrics and trauma. At this time, AirXpanders' products are not cleared or approved for sale in the United States. AirXpanders is backed by Vivo Ventures, GBS Venture Partners, Prolog Ventures, Heron Capital, Shalon Ventures and Correlation Ventures. For more information, please visit: http://www.airxpanders.com/.
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