AirXpanders, Inc., a medical device company focused on the design, manufacture, sale and distribution of the AeroForm® Tissue Expander System, announced the 4,000th commercial worldwide placement of AeroForm Tissue Expander was recently implanted in a patient for post-mastectomy, two-stage breast reconstruction.
“This is a great accomplishment for our company, and an empowering experience for the patient,” said Frank Grillo, President and CEO of AirXpanders. “Since we commercialized our technology in Australia in 2015 and the U.S. in 2017, we have seen rapid adoption of the AeroForm Tissue Expander System. With AeroForm, patients have the ability to control their own tissue expansion and preparation for the implantation of a permanent implant for breast reconstruction. The use of AeroForm is easier for the physician compared to traditional saline tissue expanders, and patients appreciate the ability to avoid several needle-sticks after surgery.”
“Adoption of our technology continues to gain steam in the U.S.,” said Laurel Burk, Director of Marketing for AirXpanders. “AeroForm is approved for use in over 200 hospitals and hospital systems in the United States, and over 80 in Australia. New U.S. hospitals and physicians are being added monthly, which is adding to our current revenue growth and laying the foundation for future growth and the opportunity for AeroForm to become the standard of care for tissue expansion in breast reconstruction.”
“During the second and third quarter, we have seen continued progress on our key goals as a newly refocused company,” continued Frank Grillo. “We have completed the restructuring of our sales force in the U.S., and now every established territory has a dedicated sales representative. Our progress in driving adoption in the U.S. is meeting or exceeding our expectations in each territory, and our focus on expense controls and working capital management continues. Consistent with our Q3 results, we are confident that our Q4 results, to be released in January 2019, will show another reduction in cash burn, as well as continued U.S. revenue growth. Our business is on track, adoption is growing, and cash burn is slowing versus prior quarters.”
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.
This announcement contains or may contain forward-looking statements that are based on managements 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, but are not limited to, the adoption rate of AeroForm, ease of use of AeroForm for physicians, the patient benefits of AeroForm over existing technologies, the potential for AeroForm to become the standard of care, the ability of the Company to control expenses and mange working capital in order to meaningfully reduce cash burn, and anticipated growth of the Company’s business and customer adoption rates.
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, filed with the Securities and Exchange Commission on October 31, 2018, 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.