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 a new publication in the July/September issue of Plastic Surgical Nursing (PSN) reinforced that patients undergoing breast reconstruction found the AeroForm dosage controller easy to use for breast tissue expansion.
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.
The PSN publication reports the results of a human factors validation study which was conducted to evaluate whether patients could correctly use the AeroForm device to complete their tissue expansion at home. Data on performance, behavioral and subjective measures were collected and analyzed for eight patients. All participants were successful in using the controller to deliver a simulated dose. Participants found the device easy to use and the training material provided adequate to understand use of the controller. The human factors validation study confirmed the simplicity of AeroForm device use during breast tissue expansion.
“The PSN publication highlights what AeroForm was designed for – giving women greater control over the tissue expansion process in a simple, straightforward fashion,” said Scott Dodson, president and CEO, AirXpanders. “As we continue to broaden our footprint in the U.S., we are delighted that more women who opt for breast reconstruction will have a chance to benefit from this cutting-edge technology.”
Additionally, the AeroForm technology was prominently featured at the London Breast Meeting (LBM), which took place September 7-9, in London. The LBM is a premier academic meeting, attracting plastic surgeons from around the world. This year’s meeting focused on “Innovations and Trends in Aesthetic and Reconstructive Breast Surgery,” including AeroForm, the first advancement in tissue expansion technology in more than 40 years. During the meeting, Dr. Tony Connell, a plastic surgeon from Perth, Australia, reviewed the technology and shared his personal experience of treating women with AeroForm.
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 publically listed company on the Australian Securities Exchange under the symbol “AXP.” AeroForm was granted U.S. FDA de novo marketing authorization in 2016, first CE mark in Europe in 2012 and is currently licensed for sale in Australia.
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, European market acceptance and U.S. sales of our product.
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.