Form 8-K

8-K — Cytosorbents Corp

Accession: 0001104659-26-109814

Filed: 2026-09-23

Period: 2026-09-22

CIK: 0001175151

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

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0001175151

2026-09-22

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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):

September 22, 2026

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)

(IRS 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 (973) 329-8885

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Securities registered pursuant to Section 12(b)

of the Securities Exchange Act of 1934:

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)

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))

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 7.01. Regulation FD Disclosure.

On September 23, 2026,

CytoSorbents Corporation (the “Company”) issued a press release, a copy of which is furnished herewith as Exhibit 99.1.*

Item 8.01. Other Events.

As previously disclosed, on

October 2, 2025, the Company received a letter from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock

Market LLC (“Nasdaq”) notifying the Company that it was not in compliance with Nasdaq Listing Rule 5550(a)(2), which

requires a minimum bid price of $1.00 per share for continued listing on the Nasdaq Capital Market (the “Minimum Bid Price Requirement”).

On September 22, 2026, the Company received a letter from the Staff confirming that the Company has regained compliance with the

Minimum Bid Price Requirement and that the matter is now closed.

As previously disclosed, on

June 29, 2026, the Company received a written notice from the Staff notifying the Company that it was not in compliance with Nasdaq

Listing Rule 5550(b)(2) because the market value of the Company’s listed securities was below the $35 million minimum

required for continued listing on the Nasdaq Capital Market (the “MVLS Requirement”). In accordance with Nasdaq Listing Rule 5810(c)(3)(C),

Nasdaq provided the Company with 180 calendar days, or until December 28, 2026, to regain compliance with the MVLS Requirement. To

regain compliance, the market value of the Company’s listed securities must equal or exceed $35 million for a minimum of 10 consecutive

business days during the compliance period, unless the Staff exercises its discretion to extend such period pursuant to Nasdaq Listing

Rule 5810(c)(3)(H).

The Company is evaluating

potential actions to regain compliance with the MVLS Requirement and intends to continue to monitor the market value of its listed securities.

The Company may also, if appropriate, consider other options to regain compliance with Nasdaq’s continued listing standards, including

by increasing its stockholders’ equity to at least $2.5 million. If the Company does not regain compliance prior to December 28,

2026, the Company will receive written notification that its securities are subject to delisting, at which time the Company may appeal

the delisting determination. There can be no assurance that the Company will regain compliance with the MVLS Requirement or otherwise

maintain the listing of its common stock on the Nasdaq Capital Market.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

See Exhibit Index below.

Exhibit Index

Exhibit No.

Description

99.1

Press Release dated September 23, 2026

104

Cover Page Interactive Data File (formatted in iXBRL)

* The information in Item 7.01 of this Current

Report, including the exhibits hereto, is to be considered “furnished” pursuant to Form 8-K and shall not be deemed “filed”

for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.

The information in this Current Report shall not be incorporated by reference into any registration statement or other document pursuant

to the Securities Act of 1933, as amended.

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: September 23, 2026

CYTOSORBENTS CORPORATION

By:

/s/ Dr. Phillip P. Chan

Name:

Dr. Phillip P. Chan

Title:

Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2625982d1_ex99-1.htm · Sequence: 2

Exhibit

99.1

CytoSorbents

Regains Compliance with Nasdaq Minimum Bid Price Requirement

PRINCETON,

N.J., September 23, 2026 -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in

the intensive care unit and cardiac surgery using blood purification, announces that it has regained compliance with the Nasdaq Stock

Market’s minimum bid price requirement of $1.00 per share.

September 22, 2026, CytoSorbents received notification from the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”)

that it has regained compliance with the minimum bid price requirement in Nasdaq Listing Rule 5550(a)(2) as a result of the

closing bid price of CytoSorbents’ common stock being $1.00 per share or greater for 10 consecutive trading sessions ending September 21,

2026. Accordingly, Nasdaq has determined that this matter is now closed.

Dr. Phillip

Chan, Chief Executive Officer of CytoSorbents stated, "We are pleased to confirm that CytoSorbents has regained compliance with

Nasdaq's minimum bid price requirement. In addition, we are working towards full compliance with Nasdaq’s Capital Market listing

requirements by addressing the minimum Market Value of Listed Securities requirement under Nasdaq Listing Rule 5550(b)(2), or satisfying

other alternative options, before the December 28, 2026 compliance date.”

“These

efforts are among the key priorities we are systematically addressing as we work to strengthen the Company and build greater

visibility and confidence among our shareholders. At the same time, we remain intensely focused on executing our core business

objectives: driving sales of CytoSorb, achieving operating cash flow breakeven in the second half of this year, advancing

DrugSorb-ATR toward FDA regulatory approval, and unlocking the strategic value of assets such as HemoDefend-BGA. We believe

continued execution against these priorities will position CytoSorbents for stronger, sustainable growth and long-term shareholder

value.”

About

CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents

Corporation is a leader in the treatment of life-threatening

conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents’ proprietary blood purification

technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily

fluids by pore capture and surface adsorption. Cartridges filled with these beads can be used with standard blood pumps already in the

hospital (e.g. dialysis, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines),

where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into

the body. CytoSorbents’ technologies are used in a number of broad applications. Specifically, two important applications are 1)

the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory

agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure and patient death. The breadth of

these critical illnesses includes, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and

pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure, and the removal of myoglobin

in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there

are few, if any, effective treatments.

CytoSorbents’

lead product, CytoSorb®, is approved in the European Union and distributed

in over 70 countries worldwide, with more than 300,000 devices used cumulatively to date. CytoSorb was originally launched in the European

Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal

in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal

in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the

United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. CytoSorb is not

yet approved or cleared in the United States.

the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational

device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due

to blood thinning drugs. It has received two FDA Breakthrough Device Designations:

one for the removal of ticagrelor and another for the removal of the direct

oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery.

The Company is actively pursuing regulatory approval of DrugSorb-ATR with the U.S. FDA and will pursue regulatory approval with Health

Canada with better visibility from the FDA. DrugSorb-ATR is not yet granted or approved in either the U.S. or Canada.

The

Company has numerous marketed products and products under development based upon this unique blood purification technology protected

by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including

ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb,

PuriFi®, HotSwap®, and others. For more information, please visit the Company’s website at https://ir.cytosorbents.com/

or follow us on Facebook and X.

Forward-Looking

Statements

This

press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities

Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives,

future targets and outlooks for our business, representations and contentions, and the outcome of our regulatory submissions, and are

not historical facts and typically are identified by use of terms such as “may,” “should,” “could,”

“expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,”

“potential,” “continue” and similar words, although some forward-looking statements are expressed differently.

You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations,

but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could

cause or contribute to such differences include, but are not limited to, our restructuring of our direct sales team and strategy in Germany,

ability to successfully obtain U.S. FDA and Health Canada marketing authorization or approval, our ability to reduce

costs, optimize operations, and achieve cash-flow break-even in the second half of 2026, our ability to appropriately finance the Company,

and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 30, 2026, as updated

by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders

issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. There

can be no assurance that the Company will be successful in maintaining its listing of its common stock on the Nasdaq Capital Market.

We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or

revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under

the Federal securities laws.

Please

Click to Follow Us on Facebook and X

U.S.

Company Contact:

Peter J. Mariani, Chief Financial Officer

305

College Road East

Princeton,

NJ 08540

ir@cytosorbents.com

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