U.S. FDA Approves CytoSorbents to Initiate U.S. STAR-T Trial For Ticagrelor Removal During Cardiothoracic Surgery

U.S. FDA Approves CytoSorbents

to Initiate U.S. STAR-T Trial For Ticagrelor Removal During Cardiothoracic Surgery

MONMOUTH JUNCTION, N.J., April 19, 2021 - CytoSorbents

Corporation (NASDAQ: CTSO), a critical care leader whose flagship E.U. approved CytoSorb blood purification

technology is intended to treat deadly conditions in critically-ill and cardiac surgery patients, announces that the U.S. Food and Drug

Administration (FDA) has granted conditional approval of its investigational device exemption (IDE) application for the U.S. Safe

and Timely Antithrombotic Removal - Ticagrelor (STAR-T) randomized, controlled trial. Based on this

conditional approval, study initiation activities, including clinical trial agreement negotiations and institutional review board (IRB)

submissions, can now commence, putting the study ahead of the Company's internal schedule. The Company has already identified and

pre-screened many high-quality U.S. clinical centers that have indicated strong interest to participate in the STAR-T trial. The Company

believes conditions for full IDE approval can be appropriately addressed within the 45-day timeframe outlined by the FDA, and once accepted,

the Company expects to provide additional detail on the trial.

Dr. David Cox, Vice President of Global Regulatory

of CytoSorbents stated, "We are pleased that the FDA has approved our randomized,

controlled clinical trial for the removal of ticagrelor (Brilinta ,AstraZeneca) during cardiothoracic surgery to reduce

perioperative bleeding complications. We will promptly address FDA's conditions of approval and finalize the IDE protocol

to best support a U.S. marketing submission of our FDA Breakthrough Device technology for this application."

Mr. Vincent Capponi, President and Chief Operating

Officer of CytoSorbents added, "We are very excited to have received the go ahead from the FDA to begin the STAR-T trial, that if

successful, is expected to support our first U.S. FDA marketing submission. In the

future, we plan to leverage the alignment with FDA and the STAR-T study infrastructure, including the academic leadership, operational

framework, and participating clinical trial sites to seek label expansions in antithrombotic removal beyond ticagrelor. This IDE

approval marks a key first step forward in our long-term U.S. commercialization strategy

to become the de facto standard of care therapy to remove antithrombotic drugs, generically called blood thinners, during cardiothoracic

surgery, with an estimated total addressable U.S. market of $1 billion."

In April 2020, the FDA granted CytoSorbents Breakthrough

Device Designation to remove ticagrelor during cardiothoracic surgery, recognizing this major unmet medical need. Each year, ticagrelor

is prescribed to millions of cardiovascular patients worldwide to reduce the risk of recurrent hearts attack, stroke or cardiovascular

death. Ticagrelor is frequently preferred as first line therapy in patients presenting to hospitals with an acute coronary syndrome in

preparation of percutaneous coronary intervention (PCI) and stent placement. However, up to 10% of these patients will require coronary

artery bypass graft (CABG) open heart surgery and as several clinical studies, such as the PLATO trial, have shown, they face

a very high risk of severe or life-threatening bleeding during surgery.

Mr. Capponi continued, "CytoSorbents'

blood purification technology offers a simple solution to mitigate bleeding risk by being placed in the cardiopulmonary bypass machine

blood circuit to directly remove ticagrelor during cardiothoracic surgery. We are working collaboratively with FDA under Breakthrough

Device Designation to aggressively pursue this opportunity and address this major unmet clinical need. This approval accelerates our internal

timeline, and with the identification of clinical sites already completed, we are now in a position to move agressively forward with the

execution of the STAR-T trial."

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents 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 outside of the US, as an extracorporeal cytokine adsorber designed to reduce the

"cytokine storm" or "cytokine release syndrome" that may result in massive inflammation, organ failure and death

in common critical illnesses. These are conditions where the risk of death may be 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.

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 $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

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