Welcome to our dedicated page for Cytosorbents news (Ticker: CTSO), a resource for investors and traders seeking the latest updates and insights on Cytosorbents stock.
Cytosorbents Corporation develops blood purification technologies for life-threatening conditions in intensive care and cardiac surgery. Its lead product, CytoSorb®, is approved in the European Union, distributed internationally, and used for cytokine adsorption and CE-marked applications that include bilirubin, myoglobin, ticagrelor, and rivaroxaban removal; in the United States it has FDA Emergency Use Authorization for adult critically ill COVID-19 patients with respiratory failure and is not otherwise approved or cleared.
Company updates commonly address quarterly and annual results, gross margin and balance-sheet actions, product launches such as HotSwap™, distribution partnerships, clinical evidence for CytoSorb therapy, and regulatory work around the investigational DrugSorb®-ATR antithrombotic removal system. The product portfolio also includes ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, ContrastSorb, PuriFi®, and related blood purification technologies.
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CytoSorbents Corporation (NASDAQ: CTSO) announced plans to report its Q1 2023 operating and financial results on May 2, 2023, after market close. Management will host a live presentation and Q&A session at 4:30 PM EDT. CytoSorbents specializes in blood purification treatments for critical care, particularly through its flagship product, CytoSorb, which addresses life-threatening conditions by reducing cytokine storms. The product is already approved in the EU and used in over 75 countries, with more than 195,000 devices utilized by the end of 2022. The company has received significant non-dilutive funding, approximately $48 million, from various U.S. government agencies. Forward-looking statements caution investors about potential risks affecting future performance.
CytoSorbents Corporation (NASDAQ: CTSO) announced the successful enrollment of 80 patients in its pivotal STAR-T trial, which is focused on the use of its DrugSorb-ATR system for reducing perioperative bleeding risks in patients undergoing cardiothoracic surgery and treated with ticagrelor. This achievement meets the second enrollment milestone and initiates a Data and Safety Monitoring Board (DSMB) review. The trial aims to enroll 120 patients across 30 centers in the U.S. and Canada and is expected to complete enrollment by summer 2023. Following this, CytoSorbents plans to file for regulatory approval with the U.S. FDA and Health Canada. The DrugSorb-ATR system has previously received FDA Breakthrough Device Designation due to the significant unmet medical need it addresses.