PALO ALTO, Calif., June 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 updated the market on the progress of its commercial roll-out in the United States. AeroForm is now available in more than one hundred (100) medical institutions and health systems, located throughout the country.
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. AeroForm was granted de novo clearance by the U.S. Food and Drug Administration (FDA) on December 21, 2016.
"AeroForm provides a solution we have long been looking for in breast reconstruction. For decades, women opting for two-stage reconstruction have had to undergo a cumbersome, uncomfortable and often logistically difficult process to expand their tissue prior to reconstructive surgery," said Neil Tanna, MD, MBA, a Long Island, N.Y.-based plastic surgeon who recently added AeroForm into his practice. "After reading multiple clinical studies about AeroForm I knew it was an option that I wanted to offer to my patients having reconstruction. I believe this needle-free, patient-controlled device will improve my patients' experiences and empower them to take back control of their time and bodies after often long journeys through breast cancer."
"We believe that AeroForm approval by medical institutions and health systems in cities across the U.S. speaks to the medical community's enthusiasm for this technology and its potential to positively redefine reconstruction in their practice and for their patients," said Scott Dodson, president and CEO of AirXpanders. "As the AirXpanders team continues a targeted market release, we look forward to working with additional providers to broaden patient access to this innovative product, which we believe stands to elevate the standard of care for reconstruction."
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 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.
Foreign Ownership Restriction:
AirXpanders' CHESS Depositary Interests (CDIs) are issued in reliance on the exemption from registration contained in Regulation S of the US Securities Act of 1933 (Securities Act) for offers or sales which are made outside the US. Accordingly, the CDIs have not been, and will not be, registered under the Securities Act or the laws of any state or other jurisdiction in the US. The holders of AirXpanders' CDIs are unable to sell the CDIs into the US or to a US person unless the re-sale of the CDIs is registered under the Securities Act or an exemption is available. Hedging transactions with regard to the CDIs may only be conducted in accordance with the Securities Act.
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, U.S. commercial market acceptance and U.S. sales of our product as well as, our expectations with respect to our ability to develop and commercialize new products including our ability to obtain reimbursement for our products; ability to become the global leader in reconstructive surgery products and to become the standard of care in two-stage breast reconstruction.
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 does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. 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 more information, refer to the Company's website at www.airxpanders.com.
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