AirXpanders (ASX:AXP), a Melbourne-based medical device company, has received US FDA de novo clearance for the AeroForm Tissue Expander System, a Class II medical device used for breast reconstruction.
AeroForm provides a needle-free alternative for women who choose reconstructive surgery following a mastectomy. It is activated by a handheld wireless controller that administers small amounts of carbon dioxide up to three times a day.
AirXpanders’ president and CEO Scott Dodson said regulatory clearance marked a major milestone and the company is poised to commence the commercial rollout in the US. AeroForm is currently available in Australia, where it was approved for sale in late 2014.
“The market opportunity for AirXpanders in the US is significant, with the total addressable market worth more than US$800 million. As US mastectomy rates continue to rise and growing numbers of women undergo breast reconstruction, we are confident AeroForm will positively redefine the reconstruction process for women in the US,” said Mr Dodson.
“While approximately 70 percent of women who opt for reconstructive surgery undergo tissue expansion to prepare a space for breast implants, little progress has been made with regard to tissue expanders over the last 40 years,” said Dr Jeffrey Ascherman, site chief of the Division of Plastic Surgery NewYork-Presbyterian/Columbia University Medical Center, professor of surgery at Columbia University Medical Center and principal investigator for AirXpanders’ US XPAND trial.
“Reconstruction is one of the last phases of a long and sometimes taxing journey for women who are treated for breast cancer. They have lost time and control, and are eager to get back to their lives. Needle-free, patient-guided expansion could be a suitable option for many women undergoing the reconstruction process.”
AirXpanders said it has engaged in a range of preparatory activities to support the US market release, including identifying and hiring the first tier of sales personnel; dialogue with targeted hospitals for initial adoption; and, conducting early industry and patient awareness initiatives.
“With the de novo FDA clearance in place, we will now accelerate the build out of our US sales force with the hiring of our direct sales team, and begin initial targeted market release in the US, similar to our successful approach in Australia,” said Mr Dodson.
“We will first be concentrating on several key high volume academic and community hospitals that participated in our pivotal and continued access trials, as we broaden surgeon training and refine processes for seamless on-boarding with nursing, billing and inventory. Simultaneously the manufacturing transfer to Costa Rica is progressing well, where we have installed our first production line which will allow for manufacturing to commence there according to schedule.
“With this US regulatory milestone, the hiring of our initial U.S. sales team and our continued progress with our manufacturing transfer, AirXpanders is excited to advance our efforts to bring the AeroForm to the US market.”