5th Prospective Trial Confirms Physician and Patient Satisfaction, Ease of Use and Convenience with AeroForm® Tissue Expander System

PALO ALTO, Calif., Oct. 9, 2017 /PRNewswire/ -- AirXpanders, Inc. (ASX: AXP) (AirXpanders or Company), 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 use of its AeroForm® Tissue Expander System was presented during the 86^th Plastic Surgery: The Meeting, the annual scientific meeting of the American Society of Plastic Surgery (ASPS), October 6-10, in Orlando, FL. 

Dr. Jeffrey Ascherman of Columbia University presented new data from the XPAND II continued access trial. The study presented the results of 50 women who received AeroForm. The primary endpoint was met with 100% of patients achieving successful expansion and exchange to breast implant (precluding non-device related failures). With AeroForm, women achieved tissue expansion in a median time of 21 days, and completed the reconstruction process in a median time of 115 days. Both surgeons and patients reported high satisfaction rates (96%). Ease of use was reported as 98% for patients and 94% for physicians, and convenience was rated at 100% for patients and 94% for physicians.

"XPAND II, our fifth prospective trial, reaffirms the consistent, outstanding performance and patient benefits of the AeroForm System we've seen across all of our clinical trials and in commercial use," said Scott Dodson, President & CEO, AirXpanders. "With our full U.S. launch underway, we are pleased to be able to provide plastic surgeons access to the most studied, peer reviewed and published tissue expander on the market today."

In addition, Dr. Martin Keisch, a radiation oncologist from Miami Shores, FL, presented on treating patients with radiation therapy with AeroForm in vivo. He presented data from the experience of Genesis Cancer Care in Perth, Australia, where more than 10 AeroForm patients have undergone radiation. The analysis showed that by considering specific radiation planning techniques related to the components of the expander, the radiation oncology team could safely deliver radiotherapy with an AeroForm expander in place. Additionally, no increase in acute toxicity was seen.

AeroForm offers a needle-free alternative for women who choose reconstructive surgery following a mastectomy. AeroForm is activated by a handheld wireless controller that administers small amounts of carbon dioxide (CO₂) up to three times a day, to gradually stretch the tissue to prepare for a breast implant. With the push of a button from the wireless controller, a preprogrammed amount of CO₂ is delivered in seconds, allowing the patient to continue with her daily activities while preparing for reconstruction.

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 Palo Alto, 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 initially granted U.S. FDA de novo marketing authorization in 2016 with subsequent 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 are forward-looking statements. These include, without limitation, the benefits offered to patients using AeroForm.

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 periodic reports filed with the Securities and Exchange Commission under the caption "Risk Factors," including its quarterly report on Form 10-Q for the quarter ended June 30, 2017. 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.

SOURCE AirXpanders, Inc.

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