AirXpanders (ASX:AXP) said yesterday it won FDA de novo clearance for its AeroForm tissue expander system designed for breast reconstruction procedures, and announced it is preparing to launch the device in the U.S.
The Palo Alto, Calif.-based company’s AeroForm tissue expander is designed for use in post-mastectomy breast reconstructions to expand and stretch the skin and underlying muscle prior to a permanent breast implant.
“While approximately 70% 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. 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,” Dr. Jeffrey Ascherman of the NewYork-Presbyterian/Columbia University Medical Center said in prepared remarks.
AirXpanders said it is engaging in a “range of preparatory activities” as it looks forward to a U.S. market release, including hiring sales personnel and opening dialogues with targetted hospitals for early adoption.
“With the de novo FDA clearance in place, we will now accelerate the build out of our U.S. sales force with the hiring of our direct sales team, and begin initial targeted market release in the U.S., similar to our successful approach in Australia. We will 1st 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 1st production line which will allow for manufacturing to commence there according to schedule. With this U.S. 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 U.S. market,” CEO Dodson said in a press release.
In June, AirXpanders said it raised $14.9 million (A$20 million) for its AeroForm tissue expander and tapped medical device veteran Scott Murcray to be its CFO/COO.
AirXpanders said the over-subscribed private placement of nearly 8.8 million shares at 56.8¢ apiece (A76¢) included both new and existing institutional investors. The proceeds are earmarked for expanding AeroForm’s commercial footprint in Australia and prepping the sales & marketing for a U.S. launch during the 1st quarter next year.