Interim Results of AirXpanders’ Multi-Centered Randomized Controlled Trial Demonstrate Faster, Needle-Free Alternative to Saline Tissue Expanders
Highly statistically significant improvement in expansion and total implant times compared to saline
PALO ALTO, Calif., April 15, 2014 /PRNewswire/ — AirXpanders Inc., a company developing novel technology for women who require tissue expansion for breast reconstruction following a mastectomy, today reported that interim data from its XPAND study show that the AeroForm(TM) device led to highly statistically significant reduction in the time it takes to expand a woman’s breast tissue after a mastectomy and to undergo reconstruction with breast implants compared to patients who went through traditional saline expansion. This interim analysis was published in the April 2014 issue of Plastic and Reconstructive Surgery. The AeroForm device is an injection-free, patient-controlled tissue expansion system that is approved in Australia and under investigation in the United States.
“Breast reconstruction following a mastectomy is long process, and tissue expansion is traditionally is one of the most tedious and painful aspects. For women to achieve expansion in 18.7 days on average and for the vast majority of the patients to report high satisfaction throughout the expansion process is extremely compelling, and further supports AeroForm as an exciting, much-needed innovation in breast reconstruction,” said Kamakshi Zeidler, M.D., principal investigator of the trial. “Patient-controlled expansion, where women are able to expand at their own pace and level of comfort, offers mastectomy patients a needle-free, more convenient option for expansion – and a chance to regain control over their body during a time in which much is out of their control. It is my expectation that with 98% of the women in the early phase of the study reporting that the AeroForm is easy to use, CO2-based expanders have the potential to be adopted universally, and transform the process of tissue expansion.”
As of the date of the publication, 115 patients had been enrolled into the XPAND study. The 87 patients in the study who have completed their expansion did so within an average of 18.7 days, consistent with all other published results of AeroForm studies to date. Traditional saline expansion requires women to visit their physician for frequent injections until they complete the process, which can take up to six months. For women in the control group who were implanted with traditional saline expanders, the expansion process took an average of 56.8 days to complete. The difference in expansion times was statistically significant (p-value was less than 0.001 with a 95% confidence interval).
Successful second-stage surgery, during which the tissue expander is exchanged for a permanent implant, has been completed in 78 patients with 53 in the investigational arm and 25 in the control arm. For patients who received AeroForm expanders, the full reconstruction process was complete in an average of 103.5 days, a statistically significant improvement over the average of 157.1 days for the control arm (p-value was less than 0.0005 with a 95% confidence interval).
“Enrollment in the ongoing XPAND study is nearly complete – only 31 patients remain – and we expect to announce the close of the trial by the end of the first half of 2014. We are working diligently towards U.S. Food and Drug Administration (FDA) regulatory approval,” said Scott Dodson, AirXpanders President and Chief Executive Officer. “We are extremely pleased to see consistency in all of the trials that we have conducted. Results continue to show positive patient experiences, significantly faster expansion times and more patient control with the AeroForm expander compared to traditional saline expanders.”
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.
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SOURCE AirXpanders Inc.