AirXpanders said the pivotal investigational device exemption trial of its AeroForm tissue expander met its primary endpoint. Results from the trial were presented at the American Society of Plastic Surgeon’s meeting in Boston.
The 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, the Palo Alto, Calif.-based company said.
“The excellent results from the Xpand pivotal trial validate that the AeroForm expander is a safe and effective alternative treatment option for the many women undergoing mastectomy and breast reconstruction. We believe women will be pleased to have the choice to control their expansion in a more convenient and faster way, during their difficult road to breast reconstruction. We have already submitted the pivotal study results to the FDA under the 510(k) clearance process so as to make this device available to all women who are considering breast reconstruction following their mastectomy,” AirXpanders CEO Scott Dodson said in prepared remarks.
The 150-patient trial examined women ages 18 to 70 reeiving breast tissue expansion, either with the company’s device or standard saline tissue expanders. The endpoint for the trial was defined as “successful expansion and exchange to a permanent implant,” which the company said it met.
The patients treated with the AeroForm had shorter expansion and reconstruction times, with the mean for the group at 21 days compared to 46 days amonst saline-treated patients, the company said. Of the patients treated with the AeroForm, 98% said they found the device “easy to use and convenient.”
The study is the base the company is using to pursue FDA clearance of the device, AirXpanders said.
“The AeroForm has provided the patients in this trial with a faster and more convenient form of tissue expansion versus saline devices. A hidden benefit of this device is the fact that the patient can play an active role in recovering her body after breast cancer. My patients have thoroughly enjoyed this role and I am confident that this will appeal to many women across the U.S. and around the world when widely available,” principal investigator Dr. Jeffrey Ascherman said in a press release.
In June, AirXpanders said it raised $28.3 million (A$36.5 million) in an oversubscribed initial public offering.
AirXpanders said it floated 73 million shares at 39¢ (A50¢) apiece, with an indicated full-diluted market capitalization of $87.7 million (A$113 million).