Full Press Release Details
Patient Enrolled in the PROCYSS Multicenter Randomized Controlled Trial Evaluating CytoSorb to Restore Hemodynamic
Stability in Patients with Refractory Septic Shock
JUNCTION, N.J., February 1, 2022 - CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of
life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption
technology, announced today that the first patient has been enrolled in the PROCYSS (Prospective, Randomized, controlled
trial with use Of CYtoSorb to reverse refractory Septic Shock) trial in Germany by Prof. Dr. Stefan
Kluge, Director, Department of Intensive Care Medicine at the University Hospital Hamburg Eppendorf and lead investigator of the PROCYSS
Refractory septic shock
(RSS) is the persistent and potentially fatal drop in blood pressure despite fluid resuscitation and high dose vasopressor use, seen in
patients with life-threatening infection and sepsis. Despite standard of care therapy, the majority of patients with RSS will die. Given
that severe hyperinflammation is thought to contribute to RSS, broad spectrum removal of inflammatory mediators such as cytokines using
CytoSorb blood purification, has demonstrated significant promise in real-world clinical usage and is now being formally evaluated in
Professor Stefan Kluge
stated, "Reversal of shock via hemodynamic stabilization is a top priority in the management of patients with RSS, and effective
therapies are urgently needed to accomplish this critical therapeutic goal. Prolonged hypotension leads to tissue and organ ischemia,
and can ultimately cause irreversible organ injury and death. Because of this, we are very pleased to lead and enroll the first patient
in the PROCYSS randomized controlled trial, to evaluate CytoSorb for this application. By defining the patient population using specific
criteria and standardizing who to treat and how to treat, we expect PROCYSS to help refine the use of CytoSorb in this extremely sick
and difficult to manage patient population."
Vice President, Medical Affairs Critical Care of CytoSorbents, stated, "Significant evidence from observational studies has demonstrated
the ability of CytoSorb to rapidly stabilize hemodynamics in patients with septic shock refractory to standard medical treatment. We designed
the randomized controlled PROCYSS trial to confirm the existing evidence of clinical benefit, but also to further our understanding of
patient selection, timing of initiation, and dosing of CytoSorb, in order to further optimize the clinical benefits provided by our therapy."
Deliargyris, Chief Medical Officer of CytoSorbents, stated, "PROCYSS is a landmark trial, and the enrollment of the first
patient represents another important milestone as we continue to execute our global clinical plan. We remain steadfast in our commitment
to invest in rigorous company-sponsored trials to generate the high-quality evidence needed to inform the global critical care community
on how CytoSorb therapy can address areas of high unmet medical need, such as sepsis. Next in line is the COSMOS (CytOSorb
TreatMent Of Critically Ill PatientS) Registry, an international prospective registry expected to capture real-world
use of CytoSorb across multiple critical care applications that is scheduled to begin enrollment in the first half of 2022."
PROCYSS multicenter, randomized controlled trial is a Company-sponsored study in Germany to evaluate the ability of CytoSorb to restore
hemodynamic stability in patients with refractory septic shock, one of the deadliest forms of sepsis. The study is expected to enroll
up to 160 patients across 20 sites and be completed by the end of 2023. For more information, see study number NCT04963920 on www.clinicaltrials.gov.
About the COSMOS Registry
COSMOS registry is a Company-sponsored international prospective registry expected to capture high fidelity clinical outcome and
resource utilization data from the real-world use of CytoSorb in a critical care setting. The registry is expected to enroll an estimated
3,000 patients. For more information, see study number NCT05146336 on www.clinicaltrials.gov.
About CytoSorbents Corporation (NASDAQ: CTSO)
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
more than 70 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 162,000 cumulative CytoSorb devices have been utilized 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 adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb -ATR Antithrombotic
Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for
the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC)
drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company has initiated
two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 20 center STAR-T (Safe
and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability
of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery.
The second is the 120-patient, 25 center STAR-D (Safe and Timely Antithrombotic Removal-Direct
Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding
risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
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 and www.cytosorb.com or
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