Current Report Filing (8-k)
April 20 2020 - 5:14PM
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):
April 20, 2020
CYTOSORBENTS CORPORATION
(Exact name of registrant as specified in
its charter)
Delaware
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001-36792
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98-0373793
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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7 Deer Park Drive, Suite K,
Monmouth Junction, New Jersey
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08852
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number, including
area code: (732) 329-8885
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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section
12(b) of the Act:
Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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common stock, $0.001 par value
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CTSO
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The Nasdaq Stock Market LLC (Nasdaq Capital Market)
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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.
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On April 20, 2020,
CytoSorbents Corporation (the “Company”) issued a press release to provide an update that the U.S. Food and Drug Administration
has granted Breakthrough Designation to CytoSorb, the Company’s lead product, for the removal of ticagrelor in a cardiopulmonary
bypass circuit during emergent and urgent cardiothoracic surgery. A copy of the press release is attached to this Current Report
on Form 8-K as Exhibit 99.1 and incorporated herein by reference.
The Company also wishes
to clarify a statement in its press release issued on April 15, 2020 and incorporated by reference into the Company's Current Report
on Form 8-K, dated April 17, 2020 (the “Press Release”). In the Press Release, the Company reported that “up
to 30% of COVID-19 patients also have septic shock.” The Company would like to clarify that various published case series
have reported that a range of 30% to 70% of critically-ill COVID-19 patients have shock or septic shock.
(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.
Dated: April 20, 2020
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CYTOSORBENTS CORPORATION
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By:
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/s/ Dr. Phillip P. Chan
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Name:
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Dr. Phillip P. Chan
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Title:
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President and
Chief Executive Officer
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