"Completing the enrollment of the primary phase of the XPAND study represents a major milestone for AirXpanders. We are currently focused on following up with the patients, ensuring we have the proper mix of subjects in each group, and completing our 510(k) filing, which we plan to submit to the U.S. Food and Drug Administration very soon. Simultaneously, we have initiated commercial sales of AeroForm in Australia and plan to support a full launch later this year," said Scott Dodson, president and chief executive officer of AirXpanders. "We are extremely pleased to see consistent results in all of the trials that have been conducted around the world. Preliminary results from the XPAND study indicate positive patient experiences, significantly faster expansion times and decreased time to complete the reconstruction process with the AeroForm expander compared with traditional saline devices. There is every reason to believe that the AeroForm technology will become the new standard of care for all two-stage reconstruction procedures."
About AirXpanders
AirXpanders Inc. (www.airxpanders.com) is a tissue expansion company focused on the area of breast 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.
Media Contact
Caitlin Nolan
MSLGROUP
AirXpanders@mslgroup.com
415-512-0770
Company Contact
Scott Dodson
President & CEO
sdodson@airxpanders.com
650-390-9008
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