|Bid||8.32 x 900|
|Ask||9.49 x 1100|
|Day's Range||8.70 - 8.99|
|52 Week Range||7.13 - 11.74|
|Beta (5Y Monthly)||0.25|
|PE Ratio (TTM)||N/A|
|Earnings Date||Mar 09, 2021|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||14.75|
The FDA has signed off conditional approval for the STAR-T study to assess CytoSorbents Corporation's (NASDAQ: CTSO) blood purification device, CytoSorb, to remove Ticagrelor. The company can now initiate clinical trial agreement negotiations and institutional review board submissions. The randomized, controlled clinical trial was designed to support U.S. marketing submission for CytoSorb, to remove AstraZeneca Plc's (NASDAQ: AZN) Brilinta (ticagrelor) during the cardiothoracic surgery to reduce perioperative bleeding complications. Ticagrelor is one of the most commonly used blood thinners to reduce the risk of cardiac death, heart attacks, and strokes in patients with the acute coronary syndrome. It is also used to reduce the rate of stent thrombosis in patients who have been stented. However, when patients on ticagrelor require emergent cardiac surgery, the risk of severe bleeding and complications is very high. Last year in January, CytoSorb scored approval in the E.U. to remove ticagrelor during surgery requiring cardiopulmonary bypass. In April 2020, CytoSorb received FDA Breakthrough Designation to remove ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery. Price Action: CTSO shares are down 2.2% at $8.8 in market trading hours on the last check Monday. See more from BenzingaClick here for options trades from BenzingaJNJ COVID-19 Vaccine Could Return This Week With Warning, Says Anthony FauciAstraZeneca's Tagrisso Scores Approval In China For Early Lung Cancer© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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.
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