CytoSorbents Announces Filing of an Investigational Device Exemption (IDE) for U.S. Trial on Ticagrelor Removal During Cardiothoracic Surgery

Announces Filing of an Investigational Device Exemption (IDE) for

U.S. Trial on Ticagrelor Removal During Cardiothoracic Surgery

JUNCTION, N.J., March 16, 2021 - CytoSorbents

Corporation (NASDAQ: CTSO) announces the filing of an Investigational Device Exemption (IDE) application to

conduct the clinical study, "Safe and Timely Antithrombotic Removal - Ticagrelor

(STAR-T)," in the United States to support an initial FDA regulatory approval. This is being done under the

previously announced FDA Breakthrough Designation

granted for the removal of ticagrelor in a cardiopulmonary bypass circuit during urgent and emergent cardiac surgery.

Dr. Efthymios Deliargyris, MD, Chief Medical

Officer of CytoSorbents stated, "We are very pleased with the investigational plan, set forth in the IDE filing, that we

believe accurately reflects the spirit of the Breakthrough Designation and are looking forward to the Agency's feedback.

We expect that our discussions with FDA will complete in the second quarter of 2021 with the goal of beginning patient enrollment

in the second half of 2021 across multiple leading U.S. institutions that have already expressed their keen interest to participate

in this trial. We plan to discuss more detail on the trial upon approval of our IDE application."

CytoSorbents Corporation (NASDAQ: CTSO)

Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb is

approved in the European Union with distribution in 67 countries around the world, as an extracorporeal cytokine adsorber

designed to reduce the "cytokine storm" or "cytokine release syndrome" that could otherwise cause

massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is

extremely high, yet no effective treatments exist. CytoSorb is also being used during and after

cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ

failure. CytoSorb has been used in more than 121,000 human treatments to date. CytoSorb has received CE-Mark

label expansions for the removal of bilirubin (liver disease), myoglobin (trauma), and both ticagrelor and rivaroxaban

during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use

in critically ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances. CytoSorb has

also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit

during emergent and urgent cardiothoracic surgery.

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. Its technologies have received non-dilutive grant, contract,

and other funding of more than $38 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes

of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations

Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous products under development based

upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications

pending, including ECOS-300CY , CytoSorb-XL , HemoDefend-RBC , HemoDefend-BGA , VetResQ , K+ontrol ,

DrugSorb , ContrastSorb, and others. For

more information, please visit the Company's websites at www.cytosorbents.com and www.cytosorb.com

Forward-Looking Statements

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,

representations and contentions 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, the risks discussed in

our Annual Report on Form 10-K, filed with the SEC on March 9, 2021, 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. 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.

Investor Relations Contact:

Public Relations Contact:

Rubenstein Public Relations