CytoSorbents (NASDAQ: CTSO) discloses FDA appeal outcome on DrugSorb

Rhea-AI Filing Summary

CytoSorbents Corporation filed a current report describing a regulatory update for its DrugSorbTM-ATR device. The company states that it issued a press release announcing the outcome of its appeal to the U.S. Food and Drug Administration regarding the FDA’s earlier denial of its De Novo Market Authorization request for DrugSorb-ATR.

The press release with details of the appeal outcome is furnished as Exhibit 99.1 to the report, rather than being summarized in the body of the filing. This filing mainly serves to formally notify investors that the FDA appeal outcome and related information are now available through that exhibit.

Insights

Regulatory and biotech analyst

CytoSorbents flags a key FDA appeal outcome for DrugSorb-ATR.

CytoSorbents reports that it has received an outcome on its appeal to the U.S. Food and Drug Administration related to an earlier De Novo Market Authorization denial for DrugSorbTM-ATR. The report itself does not describe the decision, but directs readers to a company press release furnished as Exhibit 99.1.

De Novo Market Authorization is a pathway for novel medical devices, so the appeal’s resolution can be important for DrugSorb-ATR’s U.S. regulatory path. However, because the text here does not state whether the outcome is favorable or unfavorable, the filing functions mainly as a notice of the press release rather than a standalone description of the result.

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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): August 14, 2025

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. ¨

Item 8.01 Results of Operation and Financial Condition

On August 20, 2025, CytoSorbents Corporation (the “Company”) issued a press release announcing the outcome of its appeal to the U.S. Food and Drug Administration (the “FDA”) regarding the FDA’s earlier denial of the Company’s De Novo Market Authorization request for DrugSorb^TM-ATR. A copy of the press release is furnished herewith as Exhibit 99.1.

Item 9.01 Exhibits

(d) Exhibits

Exhibit No.	Description
99.1	Press Release of the Company, dated August 20, 2025
104	Cover Page Interactive Data File (embedded with the Inline XBRL document)

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: August 20, 2025	CYTOSORBENTS CORPORATION
	By:	/s/ Dr. Phillip P. Chan
	Name:	Dr. Phillip P. Chan
	Title:	Chief Executive Officer

FAQ

What did CytoSorbents (CTSO) report in this Form 8-K?

CytoSorbents reported that it issued a press release announcing the outcome of its appeal to the U.S. FDA regarding the earlier denial of its De Novo Market Authorization request for DrugSorbTM-ATR, and furnished that press release as Exhibit 99.1.

Which CytoSorbents product is involved in the FDA appeal outcome?

The filing concerns CytoSorbents’ product DrugSorbTM-ATR, for which the company had previously sought De Novo Market Authorization from the FDA.

Does this CytoSorbents 8-K describe the FDA appeal decision in detail?

No. The report only states that a press release announcing the outcome of the FDA appeal has been issued and is attached as Exhibit 99.1; detailed terms of the outcome are contained in that exhibit, not summarized in the main text.

What exhibit did CytoSorbents include with this 8-K filing?

CytoSorbents included Exhibit 99.1, described as a press release dated August 20, 2025, as well as Exhibit 104, the cover page interactive data file embedded in the Inline XBRL document.

Which regulator is involved in CytoSorbents’ DrugSorb-ATR appeal?

The appeal outcome discussed in the report relates to the U.S. Food and Drug Administration (FDA) and its earlier denial of CytoSorbents’ De Novo Market Authorization request for DrugSorbTM-ATR.

Who signed this CytoSorbents 8-K related to the FDA appeal?

The report was signed on behalf of CytoSorbents Corporation by Dr. Phillip P. Chan, the company’s Chief Executive Officer.