AirXpanders, Inc. issued the following announcement on May 13.
AirXpanders, Inc. (ASX: AXP), a medical device company focused on the design, manufacture, sale and distribution of the AeroForm® Tissue Expander System, 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.
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.
Original source can be found here.