PALO ALTO, CA--(Marketwire - November 05, 2012) - AirXpanders Inc., a company developing novel technology for women who require tissue expansion for breast reconstruction following a mastectomy, today announced that preliminary data from two clinical studies support use of the company's AeroForm™ tissue expander. Women in both studies -- the Australian PACE trial and on-going US-based XPAND -- who received the injection-free, patient-controlled AeroForm expansion system, completed their expansion within an average of 17 days. Traditional saline expansion requires women to visit their physician for frequent injections until they complete the process, which can take up to six months.
The new AeroForm data were presented at Plastic Surgery 2012, the annual meeting of the American Society of Plastic Surgeons and the Plastic Surgery Foundation, October 26 to 30 in New Orleans.
"The patient-controlled expander offers a new dimension in breast reconstruction," said XPAND Principal Investigator Jeffrey Ascherman, MD, FACS, Site Chief, Division of Plastic Surgery at New York-Presbyterian Hospital/Columbia University Medical Center. "By eliminating the frequent office visits to inflate the expander by needle injections, the new expander offers a number of advantages over saline injections. With this new option, we hope that many of the women who have chosen to forgo reconstruction may reconsider their decision once the device is commercially available."
Dr. Ascherman presented interim data from 67 patients enrolled in the multi-center, prospective, randomized, controlled, open-label pivotal XPAND study. The results of this study will be the basis for the company's 510(k) application with the US Food and Drug Administration (FDA). Of the 66 patients who underwent reconstruction, 43 had undergone bilateral mastectomies and received tissue expanders in both breasts. To date, the study includes 72 patient-controlled expanders and 37 saline expanders. Thirty-eight of the women have completed the expansion process and have gone on to receive permanent breast implants.
The group who received the AeroForm patient-controlled expanders completed average expansion in 17 days, compared to the saline group whose expansion process extended 52 days, on average (P < 0.0001).
When answering a questionnaire about their experience with the patient-controlled expander at home, 100% of the participants expressed high satisfaction at the experience and convenience of using AeroForm expander system at home and 94% said that they would recommend the device for other women going through breast reconstruction.
The company is actively working with New York-Presbyterian Hospital/Columbia University Medical Center and ten other leading US hospitals to enroll up to 138 patients into the XPAND study. The company expects the study to be complete in 2013.
Also at the meeting, Tony Connell, FRACS, Plastic Surgeon and Principal Investigator of the PACE trial in Perth, Western Australia, presented topline results from all 40 patients in the PACE study.
The PACE study results indicate that the AeroForm expander can be a safe and valuable reconstructive tool. 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 and consistent with the interim results from the US XPAND Study.
"This is the next evolutionary step in tissue expansion technology and therefore is a great advance in the field of breast reconstruction," Dr. Connell said. "This device will prove to be of enormous benefit to all women undergoing breast reconstruction requiring tissue expansion. This device allows women to expand at home, without needles and at their own level of comfort. All of my patients who have used the device have been very satisfied with its ease of use and with the final results. I look forward to being able to offer the use of AirXpander technology to all of my breast reconstruction patients requiring tissue expansion."
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. The results of the first phase of the study, PACE-1, were published in Plastic and Reconstructive Surgery, the Journal of the American Society of Plastic Surgeons in October 2011.
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 office visits, the surgeon will insert a needle through the skin and muscle into a magnetic port to 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 six months.
"We understand the need for more effective tissue expansion technologies and are extremely pleased to see consistent, similar results in both the PACE and XPAND trials. Results continue to show positive patient experiences and outcomes with the AeroForm expander," said Scott Dodson, AirXpanders President and Chief Executive Officer. "We are diligently working towards regulatory submission in Australia and will continue to enroll subjects at leading medical centers in the United States to confirm these positive results that will be used to support our 510(k) application in 2013."
Hospitals in Boston, New York, San Jose, Sacramento, Jacksonville, and other cities across the US 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 body after cancer can potentially be eased with this needle-free technology. This technology 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. AirXpanders is backed by Vivo Ventures, GBS Venture Partners, Prolog Ventures, Heron Capital, Shalon Ventures, Correlation Ventures and Western Technology Investments.