false 0001506928 0001506928 2022-01-11 2022-01-11
 
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
 
Date of Report (Date of earliest event reported):
 
January 11, 2022
 

 
Avinger, Inc.
(Exact name of registrant as specified in its charter)
 
Delaware
 
001-36817
 
20-8873453
(State or other jurisdiction of
incorporation)
 
(Commission File Number)
 
(IRS Employer
Identification No.)
 
400 Chesapeake Drive
Redwood City, California 94063
(Address of principal executive offices, including zip code)
 
(650) 241-7900
(Registrant’s telephone number, including area code)
 
Not Applicable
(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 (see General Instruction A.2. below):
 
☐ 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))
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.001 per share
AVGR
The NASDAQ Capital Market
 
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 7.01
Regulation FD Disclosure.
 
On January 11, 2022, Avinger, Inc. (the “Company”) issued a press release announcing receipt of 510(k) clearance from the U.S. Food & Drug Administration for the Company’s Lightbox 3 imaging console. A copy of the press release is furnished as Exhibit 99.1 to this report.
 
The information furnished pursuant to this Item 7.01 and the exhibit hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
 
Item 8.01
Other Events.
 
On January 11, 2022, the Company announced receipt of 510(k) clearance from the U.S. Food & Drug Administration for the Company’s Lightbox 3 imaging console. Lightbox 3 incorporates a solid-state laser for enhanced high-definition OCT imaging, a more powerful computing platform, and a redesigned software system. The Lightbox 3 presents a significant reduction in size, weight, and cost compared to the existing platform. The Company intends to initiate a limited launch of Lightbox 3 in the first quarter of 2022 and subsequently expand to full commercial availability.
 
This Current Report on Form 8-K contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements include, but are not limited to, statements related to the potential benefits of Lightbox 3 for patients and healthcare providers and the timing and scope of the commercial launch of Lightbox 3. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties, many of which are beyond our control, that may cause actual results or events to differ materially from those projected. These risks and uncertainties, many of which are beyond our control, include risks described in the section entitled “Risk Factors” and elsewhere in our Annual Report on Form 10-K filed with the SEC on March 11, 2021 and in our other filings with the SEC, including, without limitation, our reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
 
Item 9.01
Financial Statements and Exhibits.
 
Exhibit No.
 
Description
99.1
 
104
 
Cover Page Interactive Data File (embedded within the Inline XBRL document).
 
 

 
 
SIGNATURES
 
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.
 
   
AVINGER, INC.
 
       
       
Date: January 11, 2022
By:
/s/ Mark Weinswig
 
   
Mark Weinswig
 
   
Chief Financial Officer
 
 
 
Avinger (NASDAQ:AVGR)
Historical Stock Chart
From Feb 2024 to Mar 2024 Click Here for more Avinger Charts.
Avinger (NASDAQ:AVGR)
Historical Stock Chart
From Mar 2023 to Mar 2024 Click Here for more Avinger Charts.