UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D. C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

July 9, 2019

Date of Report (date of earliest event reported)

AirXpanders, Inc.

(Exact name of Registrant as specified in charter)

Delaware

000-55781

20-2555438

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(I. R. S. Employer

Identification No.)

3047 Orchard Parkway, San Jose, CA, 95134

(Address of principal executive offices)

Registrant's telephone number, including area code: (650) 390-9000

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01 - Other Events.

AirXpanders, Inc. (the “Company” or “AirXpanders”) has received a Notice of Proposal to Suspend (“Notice”) the AeroForm Patent Controlled Tissue Expander (“AeroForm”) from the Australian Register of Therapeutic Goods (the “Register”). Suspension of AeroForm from the Register would result in the cessation of sales and distribution of AeroForm in Australia for a period of six months. The Australian Therapeutic Goods Administration (the “TGA”) has notified Emergo Australia, AirXpanders’ sponsor in the Australian market, of this Notice. On June 10, 2019 (Australia time), the Company issued an announcement on the Australian Securities Exchange regarding the receipt of the Notice. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01 - Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

No.

Description

99.1

AirXpanders Receives Notice of Proposal to Suspend AeroForm Devices from the Australian Device Register from TGA

Signature

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: July 10, 2019		AIRXPANDERS, INC.

		/s/ Frank Grillo
		Frank Grillo President and Chief Executive Officer
		(Duly Authorized Officer)

AIRXPANDERS INC 8-K