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AirXpanders® Announces Special 510(k) Submission to the US FDA for a Smooth Shell Version of the AeroForm® Tissue Expander System

SAN JOSE, Calif., May 13, 2019 /PRNewswire/ -- AirXpanders, Inc. (ASX: AXP), a medical device company focused on the design, manufacture, sale and distribution of the AeroForm® Tissue Expander System, today announced that the company has submitted a Special 510(k) pre-market notification to the US Food and Drug Administration (FDA) for a Smooth Shell version of the AeroForm Tissue Expander System.   

The purpose of the Special 510(k) pre-market notification is to request US FDA clearance for commercial use and distribution of a smooth, untextured version of the AeroForm Tissue Expander System for use in soft tissue expansion in breast reconstruction following mastectomy, for the treatment of underdeveloped breasts, and for the treatment of soft tissue deformities in the breast. The AeroForm Tissue Expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

"Following in the wake of our successful launch of the AeroForm Tissue Expander System, we are excited to bring a smooth version to market." said Frank Grillo, President and CEO of AirXpanders. "The Plastic Surgery community has embraced the textured version of our tissue expander, and they have also been asking us to provide a smooth, untextured version of AeroForm.  We are looking forward to introducing our smooth expanders and offering our unique products in both smooth and textured versions."

Later this year, AirXpanders also plans to file a Regulatory submission with the Australian Regulatory body, the Therapeutic Goods Administration (TGA), requesting approval of the smooth shell AeroForm Tissue Expander.

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.

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, including those related actual and anticipated covenant breaches under our loan agreement, strategic alternatives, the use of proceeds, cash forecasts and anticipated growth of the Company's business, are forward-looking statements. These include, without limitation, risks and uncertainties related to our ability to obtain a waiver of the covenant violations under the loan agreement from Oxford, our ability to consummate any particular financing or strategic transaction on favorable terms or at all, our ability to enhance stockholder value and/or to provide our products and services to patients and physicians, and additional business risks included in the Company's periodic reports filed with the SEC. 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, as filed with the Securities and Exchange Commission on February 28, 2019 (AUS time). AirXpanders disclaims any obligation to update information contained in any forward-looking statement, except as required by law.  For more information, refer to the Company's website at www.airxpanders.com.

Company

Company

Frank Grillo

President & CEO

Tel: +1 (650)-390-9000

Email: fgrillo@airxpanders.com

Scott Murcray
CFO & COO

Tel: +1 (650)-390-9000

Email: smurcray@airxpanders.com 

 

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SOURCE AirXpanders, Inc.