AirXpanders has reported the interim results of its multi-centered randomized controlled trial of AeroForm device.
The interim data demonstrated faster, needle-free alternative to saline tissue expanders.
This interim results of the XPAND trial were published in the April 2014 issue of Plastic and Reconstructive Surgery.
The injection-free, patient-controlled tissue expansion system is approved in Australia and is currently under investigation in the US.
As of the date of the publication, about 115 patients had been enrolled into the XPAND study.
The 87 patients in the study who have completed their expansion did so within an average of 18.7 days, consistent with all other published results of AeroForm studies to date.
Successful second-stage surgery, during which the tissue expander is exchanged for a permanent implant, has been completed in 78 patients with 53 in the investigational arm and 25 in the control arm.
AirXpanders president and CEO Scott Dodson said enrollment in the ongoing XPAND study is nearly complete – only 31 patients remain – and we expect to announce the close of the trial by the end of the first half of 2014.
"We are working diligently towards U.S. Food and Drug Administration (FDA) regulatory approval," Dodson added.
"We are extremely pleased to see consistency in all of the trials that we have conducted. Results continue to show positive patient experiences, significantly faster expansion times and more patient control with the AeroForm expander compared to traditional saline expanders."