AirXpanders Inc. ("AirXpanders", the "Company", or "we") is a U.S. based medical device company whose principal business is to design, manufacture, sell and distribute medical devices used in two-stage breast reconstruction procedures following mastectomy. Our 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, or TGA, in Australia in October 2013, commenced its initial marketing release of AeroForm in Australia in January 2015, was granted its U.S. Food and Drug Administration, or FDA, de novo marketing authorization in December 2016 (as a Class II medical device), and commenced its initial marketing release of AeroForm in the U.S. in January 2017. After we received FDA de novo clearance for AeroForm, we submitted a 510(k) application for a product change related to enhanced film material. This 510(k) was cleared by the FDA in April 2017. To date, we have 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.
Company profile
Website
Employees
Location
Fiscal year end
Industry (SIC)
Zimmer Biomet • Enovis • Steris • Intuitive Surgical • Edwards Lifesciences • Avanos Medical • MSA Safety • INVACARE • Align Technology • Surgalign ...
SEC CIK
Corporate docs
IRS number
202555438
Latest filings (excl ownership)
REVOKED
Registration or securities revoked
7 Sep 21
SEC STAFF ACTION
SEC staff action: Order
16 Mar 20
8-K
Bankruptcy or Receivership
25 Jul 19
8-K
Cost Associated with Exit or Disposal Activities
17 Jul 19
8-K
AirXpanders®Receives FDA 510(k) Clearance for a Smooth Shell Version of the AeroForm®Tissue Expander System
16 Jul 19
8-K
Departure of Directors or Certain Officers
15 Jul 19
8-K
Other Events
10 Jul 19
8-K
Results of Operations and Financial Condition
8 Jul 19
8-K
Entry into a Material Definitive Agreement
24 Jun 19
8-K
Departure of Directors or Certain Officers
29 May 19
Latest ownership filings
4
Scott Murcray
7 Mar 19
SC 13G/A
Beneficial ownership report (amended)
14 Feb 19
SC 13G/A
Beneficial ownership report (amended)
14 Feb 19
4
Scott Murcray
7 Dec 18
4
Barry Cheskin
27 Nov 18
4
Francis P Grillo
30 Oct 18
SC 13G
Beneficial ownership report
5 Sep 18
4
Zita Peach
4 Sep 18
4
Scott Murcray
4 Sep 18
3
Initial statement of insider ownership
31 Aug 18