PALO ALTO, CA--(Marketwire - September 22, 2011) - AirXpanders Inc., a company developing technology to address current unmet needs for women who require tissue expansion for breast reconstruction surgery, today announced new published data showing that its AeroForm™ breast tissue expansion device has the potential to reduce the time needed to perform the expansion and eliminate needles altogether. The study was published online in Plastic and Reconstructive Surgery, the journal of the American Society of Plastic Surgeons and serves as the basis for the company's pivotal trial in the U.S.
"The AeroForm expander offers a new paradigm in breast reconstruction," said Dr. Anthony Connell, FRACS, Mount Hospital, Perth, Western Australia, the study's lead author. "By eliminating the need for weekly office visits for the needle injections required to inflate a saline filled expander, the AeroForm expander has the potential to improve the uncomfortable and lengthy process of expansion for patients and physicians. We hope that this technology will help the approximately 75% of women who decide against reconstruction to reconsider their decision," added Dr. Connell. "Unfortunately, most women are never told that reconstruction is an option. My patients were delighted to avoid the needle inflation process and the word has spread so fast that most of my new patients have already heard about the device and would like to have access to it for their reconstruction."
AirXpanders has recently received FDA approval to begin a U.S. Investigational Device Exemption (IDE) study and physicians are actively working with their Institutional Review Boards (IRBs) at 10 leading hospitals to gain approval to enroll the first patient into the XPAND trial, a prospective, randomized, controlled, multi-center, open-label, pivotal study. The company expects to enroll up to 138 U.S. patients into the study which will serve as the basis for the company's 510(k) application, seeking clearance in the U.S.
The published results from the PACE (Patient Activated Controlled Expansion) feasibility study show that by enabling patients to play an active role in their own expansion, the average time needed by patients in the study to reach full expansion was 15 days, a fraction of that required by traditional saline methods. The needle-free technology of an AeroForm expansion may reduce the discomfort associated with saline expansions and potentially reduce infection rates by eliminating the need for percutaneous filling of the expander. The study was a prospective, open-label, single-site, single-arm feasibility clinical study in an urban university hospital setting in Perth, Australia, enrolling seven patients who were implanted with ten expanders. There were no device related adverse events reported in this study and the patients found the remote controlled expander convenient and easy to use.
Currently, when a mastectomy patient undergoes breast reconstruction, the method most often used is tissue expansion to stretch the skin and tissue of the chest wall followed by implantation of permanent breast implants. With the traditional method, a surgeon places a saline tissue expander under the skin and pectoral muscle at the site of the mastectomy. During subsequent weekly office visits, which can last as long as 22 weeks, the surgeon inserts a needle through the skin and muscle layer into the tissue expander's port, injecting as much saline into the temporary expander as the woman can tolerate.
"We recognize the need for more effective tissue expansion technologies and are extremely pleased that the patients in this study had such positive experiences and outcomes with AeroForm expander," said Scott Dodson, AirXpanders President and Chief Executive Officer. "We hope that the publication of this data will raise women's awareness of the investigational alternative offered in our current IDE trial of the AeroForm expander and will help the physicians recruit patients for this important scientific comparison to the current industry standard."
AirXpanders designed the AeroForm tissue expander to address the limitations of traditional saline expanders. The system consists of a technologically advanced self-contained tissue expander and a small hand-held wireless remote control. The AeroForm system uses compressed carbon dioxide that is gradually released through a small internal valve, in place of invasive saline injections, to fill the expander. Following a standard procedure to implant the expander, the patient can use the remote control at home to perform the expansion process as directed by her surgeon.
Hospitals in Atlanta, Boston, New York, St. Louis, Los Angeles, San Diego 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" or "NCT-01425268".
AirXpanders Inc. 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 GBS Venture Partners, Prolog Ventures, Heron Capital and Shalon Ventures.