Cytosorbents Corp

Regulatory Filings • Oct 1, 2024

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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): October 1, 2024

CYTOSORBENTS CORPORATION

(Exact name of registrant as specified in its charter)

Delaware	001-36792	98-0373793
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

| 305
College Road East Princeton , New Jersey | 08540 |
| --- | --- |
| (Address of principal executive offices) | (Zip Code) |

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):

¨ 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))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.001 par value	CTSO	The Nasdaq Stock Market LLC (Nasdaq Capital Market)

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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Item 2.02 Results of Operation and Financial Condition

On October 1, 2024, CytoSorbents Corporation (the “Company”) issued a press release announcing certain preliminary financial results for the quarter ended September 30, 2024, including estimated ranges for quarterly product sales and product gross margins. A copy of the press release is furnished herewith as Exhibit 99.1.*

Item 8.01 Other Events

The Company has submitted its DrugSorb™-ATR medical device De Novo marketing application to the U.S. Food and Drug Administration (the “FDA”) to reduce the severity of perioperative bleeding in patients on ticagrelor undergoing coronary artery bypass graft surgery. The FDA has previously granted Breakthrough Device Designation to DrugSorb-ATR to address this major unmet medical need, making it eligible for priority review. The Company has also completed its DrugSorb-ATR Health Canada Medical Device License application, which will be submitted with the expected near-term receipt of Medical Device Single Audit Program certification.

Item 9.01 Exhibits

(d) Exhibits

Exhibit No.	Description
99.1	Press Release of the Company, dated October 1, 2024
104	Cover Page Interactive Data File (embedded with the Inline XBRL
document)

• The information in Item 2.02 of this Form 8-K 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 in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

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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: October 1, 2024
By:	/s/ Dr. Phillip P. Chan
Name:	Dr. Phillip P. Chan
Title:	Chief Executive Officer

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