Note 1 - Description of Business

3 Months Ended

Mar. 31, 2018

Notes to Financial Statements

Nature of Operations [Text Block]

NOTE

1

– DESCRIPTION OF BUSINESS

AirXpanders, Inc. and its Australian branch (“AirXpanders” or the “Company”) is a Delaware corporation formed on

March 

17,

2005,

and is headquartered in Palo Alto, California. The Company's principal business is to design, manufacture, sell and distribute medical devices used in

two

-stage breast reconstruction procedures following mastectomy. AirXpanders' AeroForm Tissue Expander System (AeroForm) is a needle-free, patient-controlled tissue expander used in patients undergoing

two

-stage breast reconstruction following mastectomy prior to the insertion of a breast implant. AeroForm was granted its

first

CE mark in Europe in

October 2012,

was approved by Australia’s Therapeutic Goods Administration in

October 2013,

commenced its initial marketing release of AeroForm in Australia in

January 2015,

and was granted its U.S. Food and Drug Administration, or FDA, de novo marketing authorization in

December 2016 (

as a Class II medical device). To date, the Company has been primarily engaged in developing and launching our initial product technology, completing clinical trials, building the manufacturing infrastructure to support commercialization efforts, recruiting key personnel and raising capital.