PALO ALTO, CA--(Marketwire - June 06, 2012) - AirXpanders Inc., a company developing novel technology for women who require tissue expansion for breast reconstruction surgery, today announced it has completed enrollment in the second phase of the PACE (Patient Activated Controlled Expansion) trial supporting use of the AeroForm™ expander. Interim trial data show that the AeroForm breast tissue expansion device has the potential to improve the process for women having breast reconstruction after a mastectomy.
"The AeroForm expander offers a new dimension in breast reconstruction," says Dr. Tony Connell, FRACS, Plastic Surgeon and Principal Investigator of the PACE trial in Perth, Western Australia. "By eliminating the weekly office visits to inflate the expander by needle injections, the AeroForm expander offers a number of advantages over saline injections. 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."
Interim results from the PACE study 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 trials were prospective, open-label, single-site, single-arm studies in an urban hospital setting in Perth, Western Australia, enrolling a combined total of 40 women with placement of 71 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.
A recent paper published in Women's Health Care, the official peer-reviewed journal of The National Association of Nurse Practitioners in Women's Health (NPWH), concludes that the AeroForm expander's carbon-dioxide-based tissue expansion provides a shorter timeframe needed to achieve full expansion and leads to earlier completion of the final reconstruction surgery.
"With the conventional procedure, tissue expansion takes several months and requires multiple visits to a surgeon's office," says Susan Wysocki, WHNP-BC, FAANP. "If approved, AeroForm will allow patients to control their own rate of tissue expansion within safe limits from home and achieve a more natural-looking breast shape."
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 4-6 months.
"We understand the need for more effective tissue expansion technologies and are extremely pleased that interim results of this study show such positive patient experiences and outcomes with the AeroForm expander," said Scott Dodson, AirXpanders President and Chief Executive Officer. "We are diligently collaborating with leading medical centers in the United States to confirm these positive results and are working towards an FDA clearance."
AirXpanders is currently recruiting U.S. patients in a study called XPAND to confirm the PACE results in a larger patient population. The company is actively working with 10 leading U.S. hospitals to enroll up to 138 patients into the prospective, randomized, controlled, open-label pivotal study. The results of the study will be the basis for the company's 510(k) application, seeking clearance in the U.S. To date, this study is over 50% enrolled with completion scheduled for this summer.
Hospitals in Boston, New York, San Jose, Sacramento, Jacksonville, 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 recovering one's feminine shape 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. AirXpanders is backed by Vivo Ventures, GBS Venture Partners, Prolog Ventures, Heron Capital, Shalon Ventures, Correlation Ventures and Western Technology Investments.