Item 7.01 Regulation FD Disclosure.
On September 8, 2022, LENSAR, Inc. (the "Company") issued a press release
announcing its application for certification of the ALLY™ Adaptive Cataract
Treatment System ("ALLY" or the "ALLY System") in the European Union. A copy of
the press release is attached hereto as Exhibit 99.1 and incorporated into this
Item 7.01 by reference.
The information contained in Item 7.01 of this Current Report on Form 8-K
(including Exhibit 99.1 attached hereto) shall not be deemed "filed" for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the
"Exchange Act"), or otherwise subject to the liabilities of that section, nor
shall it be deemed incorporated by reference into any filing under the
Securities Act of 1933, as amended, or the Exchange Act, except as expressly
provided by specific reference in such a filing.
Item 8.01 Other Events.
On September 8, 2022, the Company announced its application for certification of
ALLY in the European Union. The CE Mark, if affixed following successful
completion of the certification process, allows for commercialization of ALLY in
the European Union. The application for certification in the European Union
follows U.S. FDA clearance of ALLY in June 2022. If ALLY is certified and CE
marked, the Company plans to make the system commercially available to European
surgeons through a distributor network, similar to the approach taken for its
first-generation LENSAR Laser System.
Forward-Looking Statements
Statements in this Current Report on Form 8-K regarding management's future
expectations, beliefs, intentions, goals, strategies, plans or prospects are
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995, including, but not limited to, statements
regarding the potential regulatory approval and commercialization of ALLY in
jurisdictions outside the U.S. Forward-looking statements may be identified by
words such as "anticipates," "believe," "continue," "expect," "intend," "may,"
"plan to," "potential," "projects," "will," and other similar words or
expressions, or the negative of these words or similar words or expressions.
Such forward-looking statements involve known and unknown risks, uncertainties
and other important factors, including, without limitation, the risks referred
to under the section "Risk Factors" in the Company's Quarterly Report on Form
10-Q for the quarterly period ended June 30, 2022, as such factors may be
updated from time to time in the Company's other filings with the SEC, which
filings are accessible on the SEC's website at www.sec.gov and the Investors &
Media page of the Company's website at https://ir.lensar.com. All
forward-looking statements speak only as of the date of this Current Report on
Form 8-K and, except as required by applicable law, the Company has no
obligation to update or revise any forward-looking statements contained herein,
whether as a result of any new information, future events, changed circumstances
or otherwise.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
99.1 Press Release of LENSAR, Inc., dated September 8, 2022
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document)
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