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CytoSorbents Corporation (NASDAQ: CTSO) is a prominent player in the field of critical care immunotherapy, with a strong focus on blood purification technologies. The company has made significant strides with its flagship product, CytoSorb®, which has received approval in the European Union and is distributed across 40 countries globally. CytoSorb® is an extracorporeal cytokine adsorber designed to mitigate the 'cytokine storm' or 'cytokine release syndrome' that can lead to severe inflammation, organ failure, and death in critical conditions such as sepsis, burn injuries, trauma, lung injuries, and pancreatitis. It is also employed in cancer immunotherapy and during cardiac surgeries to remove inflammatory mediators that may cause post-operative complications.
The core technology of CytoSorbents is based on biocompatible, highly porous polymer beads that efficiently purify the blood. Apart from CytoSorb®, the company offers other innovative products like ECOS-300CY, VetResQ, HemoDefend, and DrugSorb-ATR, which cater to different aspects of critical care and blood purification.
CytoSorbents operates through various segments, including Direct Sales, Distributors/Strategic Partners, and Government contracts. Its revenue is primarily driven by product sales, particularly in Germany, with additional income sourced from grants by agencies in the United States.
In Q3 2023, CytoSorbents reported a 20% growth in product sales, reaching $7.8 million, compared to $6.5 million in Q3 2022. The total revenue for the same quarter was approximately $8.8 million. The company is also advancing its pivotal STAR-T trial, with the database lock nearing completion and initial data analysis expected before the year's end.
For more detailed financial results and updates, investors can refer to the company’s official filings, such as the Form 10-K for the period ending December 31, 2023, and the Form 10-Q for the period ending March 31, 2024, available on the SEC website.
CytoSorbents announced the regulatory approval of CytoSorb® by the Taiwan Food and Drug Administration (TFDA) for treating critically ill and cardiac surgery patients. This approval covers the extracorporeal removal of cytokines, bilirubin, and myoglobin. Additionally, it allows the removal of antithrombotic drugs during cardiothoracic surgery to reduce bleeding risks. CytoSorb will be distributed in Taiwan by Hemoscien The product, used in over 237,000 treatments worldwide, aims to address critical illnesses, including sepsis, which affects approximately 150,000 people annually in Taiwan. This approval marks a significant milestone for CytoSorbents, enhancing their market reach in a progressive healthcare system.
CytoSorbents (NASDAQ: CTSO) has launched the PuriFi™ blood pump in the European Union following approval under the E.U. Medical Device Regulation (MDR). This peristaltic blood pump features innovative elements such as pre-assembled blood line kits, auto-priming, an auto-leveling bubble catcher, an intuitive touchscreen interface, optional blood warming, and a rapid 10-minute set-up time. These advancements facilitate the use of CytoSorbents’ CytoSorb® blood purification cartridge for critically ill and cardiac surgery patients. The launch, a result of a 2-year development program with Medica Group, aims to meet growing demand for efficient blood purification solutions.
CytoSorbents (NASDAQ: CTSO), a key player in blood purification for critical care and cardiac surgery, will hold its 2024 Virtual Annual Stockholders Meeting on June 6, 2024, at 10 AM EDT. Stockholders as of April 12, 2024, are entitled to participate using the 16-digit control number provided in their proxy materials. The webcast will be accessible at www.virtualshareholdermeeting.com/CTSO2024.
CytoSorbents (NASDAQ: CTSO) presented new data from the STAR Registry at the EuroPCR 2024 conference. The study, involving 102 patients on ticagrelor undergoing CABG surgery with CytoSorb blood purification, showed no device-related adverse events and a 9.8% rate of severe bleeding. The data suggest CytoSorb may reduce the wait time for surgery, lowering bleeding risks compared to historical data. This research was a top five finalist for the best scientific abstract. The results could expand CytoSorb's market as ticagrelor's patent expires and generic options become available.
CytoSorbents reported unaudited financial results for the first quarter of 2024, showcasing a robust 14% increase in product sales year over year and a 22% sequential increase. The company's product gross margins improved to 76%, marking the highest quarter for core CytoSorb sales in nearly 3 years. Additionally, the STAR-T data presented at AATS supported a favorable benefit-to-risk profile of DrugSorb-ATR in CABG patients. CytoSorbents is on track for FDA De Novo and Health Canada submissions for DrugSorb-ATR in Q3 2024.
CytoSorbents announced a virtual Key Opinion Leader and Analyst-Investor Day to discuss the STAR-T pivotal trial results and real-world experience with antithrombotic drug removal in Europe. The event will focus on severe perioperative bleeding in heart surgery patients on blood thinners, including Brilinta®. Experts will present key findings from the STAR-T trial and real-world data in the pre-specified CABG population, addressing the challenges of coronary artery disease and heart attacks globally.
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