Millions of people around the world are on blood thinners, also known as antithrombotic drugs, to reduce their risk of heart attack and stroke. Those at high risk have had a previous stroke or heart attack or require anticoagulation for a stent, a heart valve, atrial fibrillation, peripheral vascular disease, or a myriad of other reasons. However, if a patient requires unscheduled surgery and does not have 3-5 days to discontinue taking the drug, the risk of severe and potentially fatal bleeding is very high.
DrugSorbTM-ATR, is an investigational blood purification system in the U.S. that uses an equivalent polymer technology to CytoSorb to remove multiple classes of blood thinners during cardiothoracic surgery. It connects simply to a heart-lung machine blood circuit and removes these drugs while the surgery is ongoing. DrugSorb-ATR has already received two FDA Breakthrough Device Designations to remove the anti-platelet agent, Brilinta®and to remove the direct oral anticoagulants, Eliquis®and Xarelto®, during cardiothoracic surgery, highlighting and acknowledging the lack of U.S. approved or cleared drugs, biologics, or devices that can address this major unmet clinical need.
Brilinta® is often administered to heart attack victims in the emergency room as part of dual antiplatelet therapy prior to cardiac catheterization. However, up to 10% of patients will not be eligible for a stent and will require open heart surgery. But with the exception of CytoSorb in the European Union, which is approved to remove both Brilinta® and Xarelto® during cardiothoracic surgery, there is no approved reversal agent for Brilinta® in the U.S. or Canada, putting patients at high risk for bleeding. The only accepted solution is to delay surgery 3-5 days to eliminate the drug from the body, but many patients cannot afford to wait.
CytoSorbents has now completed the U.S. and Canadian STAR-T (“Safe and Timely Antithrombotic Removal of Ticagrelor”) randomized, controlled trial, enrolling 140 patients among 30 centers in the U.S. and Canada, evaluating the intraoperative use of DrugSorb-ATR during cardiothoracic surgery to reduce perioperative bleeding complications caused by Brilinta®. Topline data are expected at the end of 2023 and if positive, the Company plans to file for FDA and Health Canada marketing approval in early 2024. If approved for this indication, it would open a total addressable market in the U.S. and Canada of approximately $650 million with the expectation that ticagrelor loses patent protection in 2024.
CytoSorbents expects to resume the pivotal U.S. and Canadian STAR-D (“Safe and Timely Antithrombotic Removal – DOACs”) trial in the near future, which was paused to focus on the STAR-T trial. The STAR-D trial is designed to evaluate the ability of DrugSorb-ATR to reduce perioperative bleeding risk by removing the direct oral anticoagulants (DOACs), Eliquis®and Xarelto® during cardiothoracic surgery. Patients are typically on DOACs as lifelong anticoagulant therapy due to the risk of stroke and heart attack caused by atrial fibrillation, peripheral vascular disease, or a prior history of heart attack and stroke. The total addressable market in the U.S. and Canada for DrugSorb-ATR, should it achieve approval for this indication, is approximately $650 million as well.
We seek to establish DrugSorb-ATR as a “one-stop-shop” for blood thinner drug removal not just for cardiothoracic surgery, but for other kinds of surgery as well.