PALO ALTO, CA -- (Marketwire) -- 03/04/13 -- AirXpanders Inc., a company developing novel technology for women who require tissue expansion for breast reconstruction following a mastectomy, today announced that data from two studies support use of the company's AeroForm tissue expander.
Women in the Australian PACE trial who received the injection-free, patient-controlled AeroForm expansion system completed their expansion in an average of 17 days with 100% treatment success and no device related adverse events. Traditional saline expansion requires women to visit their physician for weekly injections until they complete the process, which can take up to six months.
All PACE trial participants who received AeroForm had a successful expansion and completed their reconstruction with placement of traditional breast implant(s).
The new AeroForm data were presented at the 17th Annual International Confederation for Plastic Reconstructive and Aesthetic Surgery (IPRAS) Annual Meeting, held in Santiago, Chile, February 24 to March 1.
"The AeroForm expander offers a new dimension in breast reconstruction," said Tony Connell, FRACS, Principal Investigator of the Patient Activated Controlled Expansion (PACE) I and II trials. "By eliminating the weekly office visits to inflate the expander by needle injections, the AeroForm expander offers a number of advantages over saline expanders. With this new option, we hope that the approximately 75% of women who have chosen to forgo reconstruction may reconsider their decision once the AeroForm expander is commercially available in markets around the world."
The PACE study results indicate that the AeroForm expander can be a safe and valuable reconstructive tool. Additionally, by enabling women to optimize their own expansion rates, the average time needed by women in the study to reach full expansion was 17 days, a fraction of that required by traditional methods.
Both phases of the PACE study were prospective, open-label, single-site, single-arm studies in an urban hospital setting in Perth, Western Australia, and have now enrolled a combined total of 40 women, including 7 subjects in the PACE-1 study and 33 subjects in the PACE-2 study with placement of 71 expanders. Previously, the company reported results from a combined total of 30 patients implanted with 51 expanders. The results of the first phase of the study were published in Plastic and Reconstructive Surgery, the Journal of the American Society of Plastic Surgeons in October 2011.
Dr. Connell also presented early results from 79 patients enrolled in the U.S. in a prospective, randomized, controlled, open-label pivotal study (XPAND). The results of the study will be the basis for the company's 510(k) application with the U.S. Food and Drug Administration (FDA).
"Traditionally, women undergoing breast reconstruction have had to endure a long process of inconvenient and sometimes painful weekly bolus saline injections to create a pocket for a permanent implant following mastectomy," said XPAND Principal Investigator Jeffrey Ascherman, MD, FACS, Site Chief, Division of Plastic Surgery at New York-Presbyterian Hospital/Columbia University Medical Center. "This investigational, remote-controlled system eliminates the need for saline injections by using compressed carbon-dioxide that is gradually released through a small internal valve to fill the expander. The patient is able to inflate the expander at home using a small hand held remote control on a daily basis, eliminating the need for weekly doctor visits."
The company is actively working with New York Presbyterian and nine other leading U.S. hospitals to enroll up to 138 patients into the XPAND study. The company expects enrollment to be complete by Spring 2013.
Currently, the method of breast reconstruction involves tissue expansion followed by placement of a breast implant. In the traditional method for expansion, a surgeon places a saline tissue expander under the skin and pectoral muscle following the mastectomy. During subsequent weekly office visits, the surgeon will insert a needle through the skin and muscle into a magnetic port and inject a bolus of saline into the expander to the point at which the woman can tolerate. The series of saline inflations needed to fill the expander can take up to 4 to 6 months.
"We understand the need for more effective tissue expansion technologies and are extremely pleased with the positive topline and interim results from the PACE 1 and PACE 2 studies. Results continue to show positive patient experiences and outcomes with the patient-controlled AeroForm expander," said Scott Dodson, AirXpanders President and Chief Executive Officer. "We are diligently working towards a limited market release in Australia slotted for April and collaborating with leading medical centers in the United States to confirm these positive results in a randomized controlled trial (XPAND) and achieve 510(k) clearance by 2014."
Hospitals in Boston, New York, Jacksonville, San Jose and other cities across the U.S. are participating in the XPAND study. For more information on the study, please visit www.clinicaltrials.gov and search "XPAND."
AirXpanders Inc. (www.airxpanders.com), is a tissue-expansion company focused on the area of breast cancer reconstruction. By employing a revolutionary patient-controlled expander, activated by a wireless remote control, the often painful process of reclaiming one's femininity, sexuality, identity and power after cancer can potentially be eased with this needle-free technology that is easy to use and may enable the patient to proceed to a permanent implant much faster than the current standard-of-care. At this time, AirXpanders' products are not cleared or approved for sale in the U.S. AirXpanders is backed by Vivo Ventures, GBS Venture Partners, Prolog Ventures, Heron Capital, Shalon Ventures, Correlation Ventures and Western Technology Investments.