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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
 
 
 

Exhibit 99.1

AVINGER01.JPG

Avinger Announces 510(k) Clearance for Lightbox 3

Next-Generation Imaging Console

 

Redwood City, Calif., January 11, 2021 - Avinger, Inc. (Nasdaq: AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new Lightbox 3 imaging console.

 

“We are excited to receive U.S. pre-marketing clearance for the Lightbox 3 imaging console. Our new Lightbox 3 delivers important advancements in imaging, portability and capability,” commented Jeff Soinski, Avinger’s President and CEO. “The Lightbox 3 is designed to accelerate new account acquisition, energize existing users and support new catheter capabilities in the future. We believe the reduced cost and increased portability of this significantly smaller console will be a major factor in efficiently expanding our Lumivascular treatment to new high-volume PAD centers and streamline the adoption of our technology.”

 

Dr. Jaafer Golzar, Avinger’s Chief Medical Officer, remarked, “Avinger has made significant advances in developing its proprietary portfolio of image-guided catheters with the introduction of three new catheter platforms in the last three years. The new Lightbox 3 represents the next leap forward with the release of an advanced imaging console designed to improve the user experience and support increased utilization of Avinger’s image-guided devices. I am confident that the high-definition imaging and simplified user interface provided by the Lightbox 3 will facilitate positive patient outcomes in the hands of both new and experienced physicians.”

 

Lightbox 3 incorporates advanced features, including an advanced solid-state laser for enhanced high-definition OCT imaging, a more powerful computing platform, and a redesigned software system with a highly intuitive user interface that emphasizes efficiency and ease-of-use. The Lightbox 3 presents a significant reduction in size, weight and cost compared to the existing platform, and is anticipated to accelerate the evaluation process and reduce barriers to developing new accounts. The Lightbox 3 fits into a case the size of a carry-on suitcase and weighs less than 20 pounds. This 90% reduction in size and weight over the prior generation Lightbox console provides for easy transport, efficient installation options, and a simplified service strategy.

 

 
 

 

The Company intends to initiate a limited launch of Lightbox 3 in the United States early in the first quarter of 2022 and subsequently expand to full commercial availability.

 

Avinger's proprietary Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during an atherectomy or CTO-crossing procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger's Lightbox console. Physicians performing atherectomy or crossing CTOs with other devices must rely solely on X-ray and tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, due to real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation.

 

About Avinger, Inc.

Avinger is a commercial-stage medical device company that designs and develops the first and only image-guided, catheter-based system for the diagnosis and treatment of patients with Peripheral Artery Disease (PAD). PAD is estimated to affect over 12 million people in the U.S. and over 200 million worldwide. Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox imaging console, the Ocelot and Tigereye™ family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices. Avinger is based in Redwood City, California. For more information, please visit www.avinger.com.

 

Follow Avinger on Twitter and Facebook.

 

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the potential benefits of Lightbox 3 for patients and healthcare providers, our ability to generate new account acquisitions, the impact of Lightbox 3 on the adoption of our image-guided devices and other technology, the impact of Lightbox 3 on the development and adoption of new catheter capabilities, the timing and scope of the commercial launch of Lightbox 3, and the impact of Lightbox 3 on our business. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include our dependency on a limited number of products; the resource requirements related to Pantheris, Tigereye and our Lightbox imaging console; the outcome of clinical trial results; the adoption of our products by healthcare providers; as well as the other risks described in the section entitled "Risk Factors" and elsewhere in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 11, 2021 and in our Quarterly Reports on Form 10-Q. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Avinger disclaims any obligation to update these forward-looking statements.

 

 
 

 

Investor Contact:

Mark Weinswig
Chief Financial Officer
Avinger, Inc.
(650) 241-7916
ir@avinger.com

 

Matt Kreps

Darrow Associates Investor Relations

(214) 597-8200

mkreps@darrowir.com