The company responsible for the first major change in breast tissue expansion in almost 40 years is getting strong support from investors.
San Jose, CA-based AirXpanders recently closed a rights offering in Australia to raise roughly A$15.7 million, along with a U.S. placement to raise about $3.4 million (A$4.6 million), equivalent to a total of about $15 million before transaction costs. Vivo Ventures invested $3.3 million of the U.S. placement and the company's board chairman invested $500,000.
"We are confident of the outlook for the company and the successful closing of our A$20.3 million raising places us in a sound financial position to deliver on our anticipated growth over the coming year," said Frank Grillo, the company's president and CEO.
AirXpanders, which is on the Australian Securities Exchange, developed the AeroForm Tissue Expander System. As MD+DI reported last year, FDA has granted de novo clearance to the device. The AeroForm is a needle-free, patient-controlled, wireless, tissue expander system for women who choose to have reconstructive surgery following a mastectomy. The device was a gold winner in the 2018 Medical Design Excellence Awards in the category of implant and tissue-replacement products, and also won the award for best in show.
The device has an interesting backstory, as it was inspired by a flat tire. Daniel Jacobs, a plastic surgeon in San Jose, CA, pulled out a carbon dioxide cartridge to fill a bicycle tire and began to wonder if he could use the same technology in a breast tissue expander.
Following a mastectomy, the AeroForm tissue expander is placed underneath the chest muscle to enable the chest wall to be stretched to make room for a permanent breast implant. The device contains a reservoir of compressed carbon dioxide. Using a hand-held, wireless dose controller, the patient can release 10cc of CO2, up to three times a day, to gradually inflate the expander. This can be done from home or work, and only takes a few seconds, according to the company.
It's an alternative to the traditional method of saline-based tissue expansion, which requires multiple medical office visits and can be painful. Each injection of saline, which can be up to 60 cc, may be painful because it stretches the skin so much, Jeffrey Ascherman, MD, of the Columbia University Department of Surgery, told MD+DI in a 2016 interview. Ascherman was the principal investigator in the company's XPAND trial.