Current Report Filing (8-k)
June 03 2019 - 8:32AM
Edgar (US Regulatory)
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): June 3, 2019
MISONIX,
INC.
(Exact
name of Registrant as specified in its charter)
New
York
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001-10986
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11-2148932
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(State
or Other Jurisdiction
of
Incorporation)
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(Commission
File Number)
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(IRS
Employer
Identification
Number)
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1938
New Highway, Farmingdale, New York
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11735
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(Address
of Principal Executive Offices)
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(Zip
Code)
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(631)
694-9555
(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:
☐ 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 (§
230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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 ☐
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Common
Shares, $0.01 par value
|
Trading
Symbol
MSON
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Name
of exchange on which registered
The
Nasdaq Global Market
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On
June 3, 2019, Misonix, Inc. (the “Misonix”) issued a press release announcing that it received 510(k) clearance by
the U.S. Food and Drug Administration (“FDA”) for Nexus, its revolutionary ultrasonic surgical platform. Misonix expects
to commence the commercialization of the Nexus platform in the United States in July.
The
press release of Misonix announcing the FDA’s 510(k) clearance of Nexus is attached as Exhibit 99.1 to this Current Report
on Form 8-K and is incorporated herein by reference.
Forward
Looking Statements
This
communication contains forward-looking statements, which address a variety of subjects including, for example, our expected timeline
of commercialization of the Nexus platform. Statements that are not historical facts, including statements about our beliefs,
plans and expectations, are forward-looking statements. Such statements are based on our current expectations and are subject
to a number of factors and uncertainties, which could cause actual results to differ materially from those described in the forward-looking
statements. Important factors and uncertainties that could cause actual results to differ materially from those described in these
forward-looking statements include, but are not limited to, the risk that our launch of Nexus may not occur on the timeline we
expect. For additional information about factors that could cause actual results to differ materially from those described in
the forward-looking statements, please refer to Misonix’s filings with the SEC, including the risk factors contained in
Misonix’s most recent Quarterly Reports on Form 10-Q and Annual Report on Form 10-K. Forward-looking statements represent
management’s current expectations and are inherently uncertain. Except as required by law, we do not undertake any obligation
to update forward-looking statements made by us to reflect subsequent events or circumstances.
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Item
9.01.
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Financial
Statements and Exhibits.
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(d)
Exhibits
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.
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Misonix, Inc.
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Dated:
June 3, 2019
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By:
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/s/
Joseph P. Dwyer
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Joseph
P. Dwyer
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Chief
Financial Officer
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