Item 7.01. Regulation FD Disclosure
On April 26, 2023, Avinger, Inc. (the "Company") issued a press release
announcing receipt of 510(k) clearance from the U.S. Food & Drug Administration
("FDA") for Tigereye® ST, the Company's next-generation image-guided chronic
total occlusion ("CTO") crossing system. 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 April 26, 2023, the Company announced receipt of 510(k) clearance from the
FDA for Tigereye ST, the Company's next-generation image-guided CTO crossing
system. Tigereye ST incorporates design upgrades to the tip configuration and
catheter shaft to increase crossing power and procedural success in challenging
lesions, as well as design enhancements for ease of image interpretation during
the procedure. The Company intends to initiate a limited launch of Tigereye ST
in the second quarter of 2023 and expects to subsequently expand to full
commercial availability within the United States during the third quarter of
2023.
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 Tigereye ST
for patients and healthcare providers and the timing and scope of the commercial
launch of Tigereye ST. 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 16, 2023, as amended by our Amendment No. 1 on Form 10-K/A filed on March
17, 2023, 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
(d) Exhibits:
Exhibit
Number Description
3.1 Press Release of Avinger, Inc. issued on April 26, 2023
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document)
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