Second U.S. FDA Breakthrough Device Designation Granted to CytoSorbents' DrugSorb-ATR Antithrombotic Removal System Adding the Removal of Market-Leading Direct Oral Anticoagulants During Urgent Cardiothoracic Surgery FDA

Second U.S. FDA Breakthrough Device Designation

Granted to CytoSorbents' DrugSorb-ATR Antithrombotic Removal System Adding the Removal of Market-Leading Direct Oral Anticoagulants

During Urgent Cardiothoracic Surgery

FDA Breakthrough Designation Granted to CytoSorbents'

DrugSorb-ATR for Removal of Apixaban and Rivaroxaban to Reduce the Risk of Serious Bleeding in Urgent Cardiothoracic Surgery

MONMOUTH JUNCTION, N.J.,

August 12, 2021 - CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions

in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that the

Company has been granted a second Breakthrough Device designation for its DrugSorb-ATR Antithrombotic Removal System by the U.S. Food

and Drug Administration (FDA). This Breakthrough Device designation covers the removal of the Direct Oral Anticoagulants (DOACs) apixaban

and rivaroxaban in a cardiopulmonary bypass circuit to reduce the likelihood of serious perioperative bleeding in urgent cardiothoracic

surgery. It follows the Breakthrough Designation received in April 2020 to remove ticagrelor for the same application.

Dr. David Cox, Vice President of Global Regulatory

Affairs of CytoSorbents remarked, "The U.S. Prescribing Information for apixaban and rivaroxaban, two leading DOACs taken to reduce

the risk of blood clots and associated complications, clearly warns that dosing should be stopped prior to a surgical procedure to reduce

the risk of bleeding. Unfortunately, in unexpected urgent cardiothoracic surgery, this is often not possible, posing the risk of

life-threatening bleeding in these patients. We are pleased that the FDA has recognized the potential of our DrugSorb-ATR Antithrombotic

Removal System to reduce levels of these drugs in a patient's blood, potentially decreasing the risk of life-threatening perioperative

bleeding. The achievement of two Breakthrough Designations in these situations where no approved or cleared alternatives exist is

a major Company milestone that is expected to expedite our regulatory and clinical goals."

Capponi, President and Chief Operating Officer of CytoSorbents stated, "We are pleased that the DrugSorb-ATR Antithrombotic Removal

System has been granted a second Breakthrough Device designation by the FDA. With this achievement, we continue to execute upon

our multi-phase U.S. strategy to potentially establish DrugSorb-ATR as an easy-to-implement, new standard of care to remove antithrombotic

drugs during cardiothoracic surgery. The U.S. STAR-T (Safe and Timely Antithrombotic Removal - Ticagrelor) pivotal randomized,

controlled clinical trial is now underway and we look forward to working with

the FDA in pursuit of the next IDE approval for the U.S. study on DOAC removal during cardiothoracic surgery. We

estimate the total addressable market for DrugSorb-ATR to remove ticagrelor, apixaban, and rivaroxaban during cardiothoracic surgery is

more than $500 million in the U.S. alone today, which is expected to significantly increase based on prescribing trends and generic availability

Apixaban (Eliquis , Bristol Myers Squibb/Pfizer)

and rivaroxaban (Xarelto , Jansen/Johnson & Johnson) are two of the most commonly prescribed anticoagulants worldwide, including

more than 5 million patients1 annually in the United States

who are chronically on these medications to reduce the risk of deadly blood clots due to atrial fibrillation, prior history of heart

attack or stroke, deep vein thrombosis, pulmonary embolism, and peripheral artery disease. We expect the number of patients prescribed

these drugs to continue to climb based on the superior performance of these agents compared to older alternatives, underlying demographic

trends in the aging baby boomer population, improved disease detection rates, and other factors. When patients on various "blood

thinners", like apixaban or rivaroxaban, require urgent cardiothoracic surgery, the risk of serious or life-threatening bleeding

and complications is very high. Based on our estimates, at least 1% of patients in the U.S. on apixaban or rivaroxaban may require urgent

cardiothoracic surgery on an annual basis. Today there are no approved or cleared alternatives in the U.S. to reduce bleeding risks during

cardiothoracic surgery caused by direct oral anticoagulants. DrugSorb-ATR has the potential to address this major unmet medical need.

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in

the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product,

CytoSorb , is approved in the European Union with distribution in 68 countries around the world as an extracorporeal cytokine

adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses

that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely

high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory

mediators that can lead to post-operative complications, including multiple organ failure. More than 143,000 CytoSorb devices have

been delivered to date. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber.

Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease

and trauma, respectively, 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. CytoSorbents' technology has also been granted FDA Breakthrough Designation for the removal of ticagrelor,

rivaroxaban, and apixaban in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery, and if FDA marketing approval is obtained,

would be marketed as DrugSorb-ATR in the United States.

Agency for Healthcare Research and Quality. Number of people with purchase in thousands by prescribed drug, United States, 1996-2018.

Medical Expenditure Panel Survey. Generated interactively May 27, 2021. CytoSorbents estimates.

CytoSorbents' 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 $39.5

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 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 ,

DrugSorb-ATR , ContrastSorb, and others. For more information, please visit the Company's websites at www.cytosorbents.com

Forward-Looking Statements

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"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:

Vice President, Investor Relations

and Corporate Communications

U.S. Public Relations Contact:

Rubenstein Public Relations