AirXpanders, Inc. (ASX: AXP), a medical device company focused on the design, manufacture, sale and distribution of the AeroForm(R) Tissue Expander System, today announced the publication of a large retrospective clinical study by Chopra, et al. which concluded that the use of AeroForm tissue expanders offers notable advantages for breast reconstruction. The paper noted that when employed in the prepectoral space, the AeroForm device may be associated with reduced infection rates and decreased utilization of healthcare and patient resources.
The retrospective data are reported in an article titled, "Two-stage Prosthetic Prepectoral Breast Reconstruction: Comparing Tissue Expansion with Carbon Dioxide and Saline," and appear in the March 25, 2019 online issue of the prestigious Plastic and Reconstructive Surgery - Global Open, an open access, peer reviewed, international journal focusing on global plastic and reconstructive surgery. The principle author, Karan Chopra, is Chief Resident in the Department of Plastic & Reconstructive Surgery, Johns Hopkins University, Baltimore, MD. Co-authors included Devinder Singh, MD, Chief of Plastic Surgery at Anne Arundel Medical Center, Annapolis, MD and Luther Holton III, MD from the Division of Plastic Surgery, Anne Arundel Medical Center, Annapolis, MD.
This study, the first of its kind to report on a novel breast expander technology combined with a newer reconstructive technique, is a retrospective analysis evaluating 115 patients with 185 breast reconstructions in a single institution. Of these breast reconstructions, 74 (40%) utilized the AeroForm Tissue Expander, and 111 (60%) utilized traditional saline expanders. Key findings in the paper included:
-- The incidence of adverse events was greater in the saline group as
compared to AeroForm (45.9% versus 32.4%)
-- Post-operative wound infection was significantly more common in the
saline group as compared with AeroForm (5.4% versus 0%)
-- Full-thickness skin necrosis occurred at a significantly higher rate
in the saline cohort as compared with AeroForm (5.4% versus 0%)
-- The AeroForm cohort showed reduced time to expand versus saline (an
average of 45 days versus 87 days) and reduced time to reconstruction
(an average of 94 days versus 143)
The authors of the paper also noted, "The clinical benefits we have noted include the ability to expand gradually in less time, elimination of the risk of iatrogenic introduction of bacteria into the implant pocket, elimination of the chance for iatrogenic rupture during needlesticks, and the ability of the patient to expand at their own rate depending on the patient's level of comfort. The benefits from a patient care perspective include less burden on the patient for clinic visitation and decreased utilization of healthcare resources during the fill process. Moreover, this expands the ability for breast centers to care for more patients since the time scheduled for expansions is eliminated and patients who live farther away require fewer visits for expansion."
"These finding support the many advantages of the AeroForm System," said Frank Grillo, President and CEO of AirXpanders, Inc. "The data suggests that reducing multiple needlesticks may be a contributing factor in reducing rates of infection and the consistent weight of the gas-filled AeroForm Expander may explain the reduced necrosis rates. This is significant for both the hospital and patient in terms of readmission costs and quality of care."
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 are forward-looking statements. These include, but are not limited to, the advantages and benefits of AeroForm over existing technologies, and the significance of the study data to hospitals and patients.
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.
