News & Events

San Jose, CA, United States - AirXpanders, Inc. (ASX: AXP), a medical device company focused on the design, manufacture, sale and distribution of the AeroForm® Tissue Expander System, today announced that new data on the latest version of the AeroForm (V3.0) confirmed the device's overall success and patient and physician satisfaction as evaluated in the XPAND Australia post-market clinical study. 

"The study results demonstrate the latest version of the AeroForm Tissue Expander improves upon previous iterations of the device and continues to facilitate treatment success," said Principal Investigator to the XPAND Australia trial Dr. Tony Connell. "While prior versions of AeroForm exhibited an undesirable level of CO2 permeation, the latest version, which is available for sale in both the US and Australia, did not. There were no permeation-related complications or device issues reported and both patients and physicians reported high rates of satisfaction." 

The XPAND Australia study was designed to evaluate improvements made to the AeroForm Tissue Expander. The study outcome confirmed successful completion of second -stage breast reconstruction following mastectomy and showed much less noticeable CO2 permeation during clinical use. These latest study results were consistent with prior clinical results, which showed the AeroForm device scored very high on patient and physician satisfaction and enabled a much earlier time to full expansion than seen in the literature for saline expanders. 

Data from the XPAND Australia study was presented by Dr. Devinder Singh, Chief & Medical Director of Plastic Surgery at the Anne Arundel Medical Center in Maryland, at the 87th Plastic Surgery: The Meeting, the annual gathering of the American Society of Plastic Surgery (ASPS) held between 28 September and 1 October. "I am honored to be able to present Dr. Connell's data. This study clearly confirms that the latest version of AeroForm performs even better than the prior version, and overall satisfaction continues to be very high. AeroForm continues to be a game-changing alternative for my breast reconstruction patients and a great addition to my practice." 

The study results presented at ASPS were consistent with previous clinical results seen with the AeroForm device. Primary Treatment Success (defined as the successful exchange of AeroForm) was 100% and the Treatment Success with All Cause Analysis Rate (including all failures) was 98%. The median days to complete expansion was 21 days, while median time to exchange was 96 days. Satisfaction with the device was very high, with more than 96% of patients and physicians responding they were very satisfied with the device. 

"We are very pleased to see such strong results from the XPAND Australia trial, which confirm the feedback we receive from patients and physicians every day," said Frank Grillo, President & CEO, AirXpanders. "We very much appreciate the strong commitment to our technology shown by Dr. Connell and the clinical investigators in this study, and we are excited to provide the latest version of our breakthrough AeroForm technology to surgeons and their patients throughout Australia and the US." 

Company Contact
Laurel Burk
Director of Marketing
Tel: +1 (650) 390-9000
Email: [email protected]

Investor Relations
Arthur Chan
WE Buchan
Tel: +61 (2) 9237 2805 / +61 (0) 404369388
Email: [email protected]

Australia Distributor
Spiran
Adrian Magnera
CEO
Tel: +61 (08) 8132 0300
Email: [email protected]

About AirXpanders 
Founded in 2005, AirXpanders, Inc. (www.airxpanders.com) designs, manufactures and markets innovative medical devices to improve breast reconstruction. The Company's AeroForm Tissue Expander System, is used in patients undergoing two-stage breast reconstruction following mastectomy. Headquartered in San Jose, California, AirXpanders' vision is to be the global leader in reconstructive surgery products and to become the standard of care in two-stage breast reconstruction. AirXpanders is a publicly listed Company on the Australian Securities Exchange under the symbol "AXP." AeroForm was granted U.S. FDA de novo marketing authorization in 2016, subsequent U.S. market clearance in 2017, first CE mark in Europe in 2012, and is currently licensed for sale in Australia. 

Forward-Looking Statements 

This announcement contains or may contain forward-looking statements that are based on management's beliefs, assumptions and expectations and on information currently available to management. 

All statements that address operating performance, events or developments that we expect or anticipate will occur in the future, including the conclusions of the results of the XPAND trial, the comparability of the current trial results with past trial results, superiority of the performance of the current version of AeroForm over the prior version, and the characterization of AeroForm as "game-changing" and as a "breakthrough", and anticipated growth of the Company's business are forward-looking statements. These include, without limitation, risks and uncertainties related to market conditions and the satisfaction of customary closing conditions related to the Rights Offering and the US Placement, and additional business risks included in the Company's periodic reports filed with the SEC. 

Management believes that these forward-looking statements are reasonable when made. You should not place undue reliance on forward-looking statements because they speak only as of the date when made. AirXpanders may not actually achieve the plans, projections or expectations disclosed in forward-looking statements. Actual results, developments or events could differ materially from those disclosed in the forward-looking statements. For additional information and considerations regarding the risks faced by AirXpanders that could cause actual results to differ materially, see its most recent Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission on July 31, 2018 (U.S. time), and in the Registration Statement on Form S-1 (including the final prospectus) related to the Rights Offering, including under the caption "Risk Factors" as well as other periodic reports filed with the SEC from time to time. AirXpanders disclaims any obligation to update information contained in any forward-looking statement, except as required by law. 

For more information, refer to the Company's website at www.airxpanders.com.