Medical Device Daily Senior

There has to be a better way.

That sentiment is what inspired the development of a new breast tissue expansion device for mastectomy patients undergoing breast reconstruction. The device, called AeroForm, was developed by AirXpanders (Palo Alto, California), which recently received an investigational device exemption from FDA to move forward with a clinical trial evaluating the technology.

The prospective, randomized, controlled, open-label pivotal study, XPAND (AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction), will be conducted at multiple centers across the U.S. AirXpanders said the results will be used as the basis for its AeroForm 510(k) filing with the FDA.

Scott Dodson, president/CEO of AirXpanders, told Medical Device Daily that the current method for undergoing breast reconstruction following a mastectomy is a procedure during which the surgeon creates a space for a permanent implant. To do this, the surgeon makes a small incision into the woman's pectoral muscle, inserts a silicone bag. Then, during weekly office visits, the surgeon inserts a needle through the skin into the tissue expander's port to inject saline into the temporary implant. These weekly injections continue for upwards of four months, Dodson said.

So Daniel Jacobs, MD, a practicing plastic surgeon and one of the co-founders of AirXpanders, decided there had to be a better way.

What AirXpanders ended up coming up with was a breast tissue expansion device that would address the limitations of traditional saline expanders. The AeroForm tissue expander consists of a technologically advanced self-contained tissue expander and a small hand-held wireless remote control. Dodson said the system uses compressed carbon dioxide that is gradually released through a small internal valve, in place of invasive saline injections, to fill the expander. After a standard procedure to implant the expander, the patient is able to inflate the expander herself at home using the remote control, eliminating the need for weekly doctor visits and needle-based saline injections.

The patient can inflate the expander up to three times a day with a three-hour lock-out between doses. “We thought if we could expand the patient on a gradual daily basis we could get her there quicker,“ Dodson told MDD.

The way the remote control part of the system works is that the patient waves it over the implant area to allow it to communicate with the implant.

“It's like using a stud finder on the wall to find out where a stud is,“ Dodson said. “This dose controller communicates when it is over the implant . . . once you're in the sweet spot you simply press the button and immediately a 10 cc dose is delivered.“

He said the company recently completed its feasibility trial in Australia which showed that the implant was able to reach full expansion in about two weeks using the new device.

“This is a significant event in the fact that women want to get on to the recovery phase after they've gone through this horrible ordeal with cancer . . . we validated that we can help get them there quicker,“ Dodson said.

AirXpanders noted that the randomized, controlled clinical trial is designed to directly compare the outcomes of tissue expansion using the traditional saline expansion method to the investigational AeroForm, remote-controlled, needle-free tissue expander. Enrollment will continue until a total of 92 AeroForm devices have been implanted and 46 saline expanders have been implanted. Dodson said the company expects the trial to take six to eight months to complete.

Participating sites include hospitals in Atlanta, Boston, New York, St. Louis, San Diego and other cities across the U.S., the company noted.

“We're very blessed to have some great sites on board with this study, we have not been told no by anyone, there has been great physician receptivity to this trial, which in my 25 years of working with medical devices that's very rare . . . it's such a dramatic improvement on what's been done,“ Dodson said. He added that reimbursement is already in place for the technology through the Women's Healthcare Act of 1998.

“We're pleased the FDA has granted us approval to start our pivotal study,“ Dodson said. “We see an opportunity to help mastectomy patients restore their shape after the devastating effects of breast cancer and put some degree of control over recovery in their hands. We look forward to beginning study enrollment and collecting the data that will be submitted to the FDA in support of our 510(k) application.“

He added that, given the positive momentum for the company at this time, AirXpanders is initiating a new round of financing to support clinical and commercial activities for the near term and are soliciting new investors to participate with the company's existing investors.

“We are fortunate to have such committed investors and expect full insider participation,“ Dodson said. “It's always good, however, to improve the capacity around the table, which is what we will seek to do with this round.“

AirXpanders has previously raised $8 million through a $5 million Series C financing led by GBS Ventures in April 2010 and an additional $3 million working capital line from Oxford Finance in February.

Amanda Pedersen, 912-660-2282