Country for PR: United States
Contributor: PR Newswire New York
Thursday, April 04 2019 - 09:36
AsiaNet
AirXpanders Announces New Data Demonstrating Reduced Infection Rates and Decreased Utilization of Healthcare Resources Associated with AeroForm
SAN JOSE, Calif., April 4, 2019 /PRNewswire-AsiaNet/ --

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.

Logo - https://mma.prnewswire.com/media/554207/AirXpanders_Logo.jpg

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. For additional information and 
considerations regarding the risks faced by AirXpanders that could cause actual 
results to differ materially, see its most recent Annual Report on Form 10-K, 
filed with the Securities and Exchange Commission on February 28, 2019, 
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.  

AirXpanders, Inc.	            Australia Distributor
Laurel Burk                         Spiran 
Director, Marketing                 Adrian Magnera
Tel: +1 (650) 390-9000              CEO
Email: lburk@airxpanders.com        Tel: +61 (08) 8132 03 00
                                    Email: adrian@spiran.care

For more information, refer to the Company's website at www.airxpanders.com.

SOURCE  AirXpanders, Inc.