Current Report Filing (8-k)
December 26 2017 - 6:41AM
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):
December 21, 2017
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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¨
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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¨
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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¨
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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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¨
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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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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.
¨
On December 21, 2017, CytoSorbents Corporation (the “Company”) issued a press release announcing that the U.S. Food
and Drug Administration granted approval of the Company’s REFRESH 2 Investigational Device Exemption application, subject
to certain conditions related to requested clarifications and changes to the patient consent form and Instructions for Use document.
The full text of the press release is filed as Exhibit 99.1
to this Current Report on Form 8-K.
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.
Dated: December 22, 2017
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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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