AirXpanders Inc., a company developing novel technology for women who require tissue expansion for breast reconstruction following a mastectomy, today announced the opening of its Initial Public Offering (IPO) in Australia. The company's IPO, fully underwritten by Canaccord Genuity, aims to raise AU $36.5 million and seeks to list on the Australian Securities Exchange.
AirXpanders is a medical device company focused on the design, manufacture, sale and distribution of its AeroForm® tissue expander, which is approved for sale in Europe and Australia. The company is expecting results from its pivotal trial shortly and anticipates that AeroForm will be reviewed for clearance by the U.S. Food and Drug Administration (FDA) this year. Subject to receiving marketing clearance, AirXpanders is aiming to commercialize AeroForm in the U.S. in early 2016.
Tissue expanders are used in breast reconstruction procedures following mastectomy to expand and stretch the skin and underlying muscle prior to the placement of a permanent breast implant. Tissue expansion via traditional saline-based expanders is described by patients as an unpleasant, painful and time consuming procedure. Patients must regularly attend the surgeon's office over a period of weeks or months to receive a series of saline injections through the skin and into the tissue expander.
AeroForm is needle-free, and activated by a patient via a wireless remote control. To date, in clinical trials and commercial settings with multiple leading Australian and U.S. breast reconstruction surgeons, AeroForm has been successfully used in more than 350 patients, providing faster and less painful tissue expansion with a significantly reduced need for surgeon office visits.
AirXpanders estimates that in the U.S. alone, the current market for tissue expanders is approximately 120,000 units per year; however, many women are still not fully informed of their reconstruction rights and options. Major efforts are underway to improve the visibility of women's options and AirXpanders is fully committed to helping inform women of their choices. The company estimates that if women in the U.S. were fully informed of their options, the addressable market is approximately 350,000 units per year.
"We believe that every woman deserves a comfortable, efficient breast reconstruction journey and the highest possible quality of life following a mastectomy, and that AeroForm is the best innovation in tissue expanders in decades. As a result, we consider AeroForm to be an attractive and compelling new alternative for this important patient group in a significant market," said Scott Dodson, president and CEO of AirXpanders. "We are pleased to invite investors to share in AirXpanders' exciting future as we scale up our manufacturing capacity and our sales and marketing infrastructure to undertake a full commercial launch of AeroForm in both Australia and the U.S."
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. At this time, AirXpanders' products are not cleared or approved for sale in the U.S. AirXpanders is backed by Vivo Ventures, GBS Venture Partners, Prolog Ventures, Heron Capital, Shalon Ventures, Correlation Ventures and Western Technology Investments.