CytoSorbents (CTSO) Files 8-K on FDA Denial, Launches Appeal Process

Rhea-AI Filing Summary

CytoSorbents Corporation (Nasdaq: CTSO) filed a Form 8-K on June 24, 2025 to disclose a material regulatory development. Under Item 8.01 – Other Events, the company reported that it has decided to appeal the U.S. Food & Drug Administration’s (FDA) denial letter related to its De Novo request for DrugSorb-ATR, a blood purification device designed to remove antithrombotic agents during cardiothoracic surgery. The filing furnishes a press release (Exhibit 99.1) as additional detail; however, that release is not included in the body of the 8-K.

The appeal process indicates that management believes there are sufficient grounds to contest the FDA’s decision, but the 8-K offers no timetable, data, or probability of success. No sales, earnings, or forecast information is provided, and no other corporate actions (financing, partnerships, leadership changes) are mentioned. Investors should note that DrugSorb-ATR represents an important U.S. commercial opportunity for CTSO, but the denial—now under appeal—introduces regulatory uncertainty and potential delays to market entry.

Positive

• None.

Negative

• FDA denial of the De Novo request for DrugSorb-ATR creates regulatory uncertainty and delays potential U.S. commercialization, posing a material setback to CTSO’s growth thesis.

Insights

Regulatory Affairs Analyst

TL;DR: FDA denial on DrugSorb-ATR is negative; appeal adds uncertainty without new data.

The filing confirms that FDA issued a denial letter for the De Novo submission of DrugSorb-ATR and that CytoSorbents will appeal. An appeal preserves optionality but does not reverse the decision or shorten timelines; historically, De Novo appeals can take 6-12 months and success rates vary. No supplementary clinical data or engagement plan with FDA is disclosed, leaving investors unable to gauge the likelihood of reversal. Given DrugSorb-ATR’s potential to unlock a sizable U.S. cardiac surgery market, the setback is material. Until clarity emerges, revenue expectations linked to U.S. commercialization should be pushed out, and regulatory risk premium on the stock should rise.

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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): June 24, 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 Other Events.

On June 24, 2025, CytoSorbents Corporation issued a press release announcing its decision to appeal the U.S. Food and Drug Administration denial letter regarding the Company’s De Novo Request for DrugSorb-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 June 24, 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: June 24, 2025	CYTOSORBENTS CORPORATION
	By:	/s/ Dr. Phillip P. Chan
	Name:	Dr. Phillip P. Chan
	Title:	Chief Executive Officer

FAQ

What did CytoSorbents (CTSO) disclose in its June 24, 2025 Form 8-K?

The company announced it will appeal the FDA’s denial of its De Novo request for DrugSorb-ATR.

Why is the FDA denial significant for CTSO investors?

DrugSorb-ATR is a key product candidate; the denial could delay or prevent U.S. market entry, affecting future revenues.

Does the 8-K provide a timeline for the appeal process?

No. The filing does not state any expected timeline or next steps beyond the decision to appeal.

Were any financial metrics or earnings figures included in this filing?

No financial metrics, forecasts, or earnings data were provided in this Form 8-K.

Is there any other material event disclosed alongside the appeal?

No. The 8-K references only the appeal decision and furnishes a related press release as Exhibit 99.1.