Development Update: U.S. FDA Grants Breakthrough Designation to CytoSorb for Removal of Ticagrelor During Cardiopulmonary Bypass in Emergent and Urgent Cardiothoracic Surgery

Development Update: U.S. FDA Grants Breakthrough

Designation to CytoSorb for Removal of Ticagrelor During Cardiopulmonary Bypass in Emergent and Urgent Cardiothoracic Surgery

MONMOUTH JUNCTION, N.J., April 20, 2020

-- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb

blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients

around the world, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Designation to CytoSorb

for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery. The Breakthrough

Devices Program provides for more effective treatment of life-threatening or irreversibly debilitating disease or conditions,

in this case the need to reverse the effects of ticagrelor in emergent or urgent cardiac surgery that can otherwise cause a high

risk of serious or life-threatening bleeding. Through Breakthrough Designation, FDA will work with CytoSorbents to expedite the

development, assessment, and regulatory review of CytoSorb for the removal of ticagrelor, while maintaining statutory standards

of regulatory approval (e.g., 510(k), de novo 510(k) or premarket approval (PMA)) consistent with the Agency's mission

to protect and promote public health.

Ticagrelor (Astra Zeneca - Brilinta ,

Brilique ) is one of the most commonly used anti-platelet drugs or "blood thinners" to reduce the risk

of cardiac death, heart attacks, and strokes in patients with acute coronary syndrome (ACS; i.e., situations where the blood supplied

to the heart is suddenly blocked) or a history of a heart attack. It is also used to reduce the rate of stent thrombosis in patients

who have been stented for treatment of ACS. However, when patients on ticagrelor require emergent cardiac surgery (e.g., coronary

artery bypass graft surgery or CABG, dissecting aortic aneurysm repair, infective endocarditis, etc.), the risk of serious or

life-threatening bleeding and complications is very high. There are no approved or cleared therapies in the U.S. to rapidly reverse

the effects of, or remove ticagrelor in these patients.

Mr. Vincent Capponi, Chief Operating Officer

of CytoSorbents stated, "We are excited to receive FDA Breakthrough Designation of CytoSorb for the removal of ticagrelor

during emergent and urgent cardiothoracic surgery. This breakthrough designation represents another constructive regulatory step

forward on the heels of the recent Emergency Use Authorization (EUA) granted by FDA for use of CytoSorb in critically-ill

COVID-19 patients. We believe this represents an important step towards our goal of obtaining U.S. regulatory approval of CytoSorb

for this indication. Following the E.U. approval of CytoSorb to remove ticagrelor during cardiothoracic surgery, we believe

this Breakthrough Designation presents a unique opportunity to accelerate the approval process and availability of CytoSorb in

the U.S., where no other alternatives are approved. We appreciate the Agency's positive decision and look forward to working

with them to define the regulatory path for approval."

Dr. Phillip Chan, MD, PhD, Chief Executive

Officer of CytoSorbents added, "Ticagrelor is a blockbuster anti-platelet agent that is used widely in patients with ischemic

cardiac disease, but is also associated with significant bleeding risk. For example, in the "Study of Platelet Inhibition

and Patient Outcomes (PLATO) trial, the incidence of "major fatal/life-threatening" CABG-related bleeding in

patients admitted with signs and symptoms of a heart attack, who were administered ticagrelor as part of dual-antiplatelet therapy,

was approximately 65% in patients who required emergent CABG within a day, and more than 40% in patients who underwent urgent

CABG within two to four days of receiving the last dose of ticagrelor. Of the three major P2Y12 platelet inhibitors

- clopidogrel, ticagrelor, and prasugrel - it is currently believed that only the effect of ticagrelor is theoretically reversible.

However, because of the absence of an effective reversal agent, this safety advantage has never been realized. We have already

reported on a landmark observational study that showed the potential for a significant reduction in bleeding risk, and

another study highlighting an approximate $5,000 projected costs savings, when CytoSorb is used with patients on ticagrelor

undergoing emergent cardiac surgery, in comparison to patient outcomes when CytoSorb was not used. As we seek to leverage our

E.U. approval abroad, we look to collaborate with the FDA under this Breakthrough Designation for the potential benefit of patients

For more information about the FDA Breakthrough

Devices Program and how it can facilitate collaboration with the FDA and the Company, please see the section below.

About FDA Breakthrough Devices Program

and Breakthrough Designation

The Breakthrough Devices Program

was established to expedite the development and prioritize the review of certain medical devices that provide for more effective

treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Under this program, the FDA can

assign Breakthrough Designation to those devices:

Specifically, the FDA may:

About CytoSorbents Corporation (NASDAQ:

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 58 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 has been used in more than 80,000 human treatments to date. CytoSorb has 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 nearly $29 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of

Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), the U.S. Army,

U.S. Special Operations Command (USSOCOM), the U.S. Air Force, 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 CytoSorb-XL , HemoDefend , VetResQ , K+ontrol ,

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

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, 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, our ability to leverage designation of CytoSorb

as a breakthrough device under the FDA's Breakthrough Devices Program in order to expedite the development, assessment, and

regulatory review of CytoSorb, as well as the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March

5, 2020, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, 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,

particularly in light of the current coronavirus pandemic, where businesses can be impacted by rapidly changing state and federal

regulations, as well as the health and availability of their workforce. 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.

CytoSorbents Contact:

Investor Relations Contact:

Public Relations Contact:

Rubenstein Public Relations

SOURCE CytoSorbents Corporation