CytoSorb® is Approved and Available for the Removal of Ticagrelor, a Leading Anti-Platelet Drug, During Cardiopulmonary Bypass in the E.U.
CytoSorb is the only approved therapy to remove ticagrelor in the European Union, and is intended to address a major unmet medical need of potentially life-threatening postoperative bleeding in cardiothoracic surgery patients on the drug
MONMOUTH JUNCTION, N.J., Jan. 29, 2020 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ:CTSO), a critical care immunotherapy leader specializing in blood purification, announces that CytoSorb® is now approved and immediately available for the removal of the anti-platelet agent, ticagrelor, during surgery requiring cardiopulmonary bypass (CPB), with the achievement of European Union regulatory approval and CE Mark label expansion for this indication.
Ticagrelor (Astra Zeneca - Brilinta®, Brilique®) is one of the most commonly used anti-platelet drugs to reduce the risk of cardiac death, heart attacks, and strokes in patients with either a history of a heart attack, or those actively undergoing percutaneous coronary intervention (PCI) with stent placement for acute coronary syndrome or heart attack. However, in patients on the drug requiring urgent or emergent coronary artery bypass graft (CABG) surgery or other cardiothoracic surgery procedure, the risk of major fatal/life-threatening bleeding has been reported to be as high as 65%. CytoSorb rapidly removes ticagrelor from blood. The use of CytoSorb during emergency cardiac surgery significantly reduced post-operative bleeding complications in a landmark observational study and had projected cost savings of approximately $5,000 per patient, including the cost of the device.
Mr. Vincent Capponi, Chief Operating Officer of CytoSorbents stated, "CytoSorb is the only approved therapy to remove ticagrelor in the European Union and in all 58 countries where CytoSorb is distributed. Cardiothoracic surgeons in these territories can now use CytoSorb on-label during surgery involving cardiopulmonary bypass, to rapidly remove ticagrelor from the body in 1-2 hours, as compared to 3-7 days with natural clearance, with the intent to reduce perioperative bleeding complications caused by this potent anti-platelet agent, while restoring natural hemostasis. CytoSorb is easily installed into a side circuit of the heart-lung machine during cardiopulmonary bypass, and has been used safely in thousands of cardiac surgeries for other reasons to date."
The majority of ticagrelor usage is in patients with acute coronary syndrome, or a history of heart attack, who have a much higher rate of cardiac surgery than the general population. Overall, the 1.1 million hospital admissions annually for acute coronary syndrome in the U.S. drives approximately 400,000 CABG procedures each year. In the European Union, there are approximately 250,000 CABG procedures annually, with nearly 100,000 in Germany alone.
Mr. Capponi continued, "Bleeding complications are the major adverse event for all three major anti-platelet drugs (ticagrelor, clopidogrel, and prasugrel) used in dual anti-platelet therapy for acute coronary syndrome. Of these, only ticagrelor has the distinction of being technically reversible – a theoretical safety benefit that until now has not been realized because no reversal agent had been approved in the U.S., Europe, or elsewhere. CytoSorb changes that. With the approval of CytoSorb for this indication, it may encourage a preference in the selection of ticagrelor, currently used in roughly a third of all heart attack patients in the U.S. today, as a first-line therapy in patients with acute coronary syndrome, given that roughly 10-15% of these patients, or approximately 110,000-165,000 patients in the U.S., and approximately 70,000-100,000 patients in Europe each year will require emergent or urgent cardiac surgery and will be at high risk of bleeding."
Mr. Capponi concluded, "Now that we can officially market this application on-label internationally, we plan to drive CytoSorb as standard of care for the removal of ticagrelor during cardiopulmonary bypass procedures in every country we serve, supported by additional studies in the U.K and elsewhere. In addition, we are aggressively pursuing an approval path for this application in the United States as well."
Ticagrelor is marketed by Astra Zeneca and sold under the tradenames Brilique® in the European Union and Brilinta® in the United States, with projected worldwide sales of more than $1.5 billion in 2019, with more than half of sales coming from Europe, emerging markets, and rest of world.
A common example of how CytoSorb will be used is as follows: A patient is having an acute heart attack, is evaluated in the hospital, and is administered dual anti-platelet therapy including aspirin and ticagrelor prior to going to the catheterization lab for percutaneous coronary intervention (PCI). But because of multi-vessel coronary artery disease, or persistent ischemia, or damage to the coronary artery, the patient requires emergency open heart CABG surgery but because of ticagrelor, risks bleeding that does not stop. Such a patient often requires the postoperative transfusion of packed red blood cells and platelets, has high surgical drainage and blood loss, may need to be taken back to surgery with a re-opening of the chest to evaluate the source of bleeding, and has an increased risk of death. CytoSorb will be used intraoperatively during cardiac surgery to rapidly remove ticagrelor with the goal of reducing these morbid and costly bleeding complications.
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® is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorbents is conducting its pivotal REFRESH 2-AKI trial – a multi-center, randomized controlled, clinical trial intended to support U.S. regulatory approval of CytoSorb for use in a heart-lung machine during complex cardiac surgery to reduce organ injury. The Company has also initiated the company-sponsored U.K. TISORB trial evaluating the removal of ticagrelor in emergency cardiac surgery patients. CytoSorb® has been used in more than 80,000 human treatments to date.
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 approximately $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), 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 www.cytosorb.com or follow us on Facebook and Twitter.
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