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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 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.
CytoSorbents Corporation (NASDAQ: CTSO) announces the retirement of Chairman Al W. Kraus, effective June 2023. Kraus has been a pivotal figure in the company for two decades, overseeing its transformation to focus on life-threatening conditions treated through blood purification technology. Under his leadership, CytoSorbents has performed over 200,000 treatments, particularly for sepsis and septic shock. Dr. Phillip Chan, CEO, praised Kraus's contributions and indicated that he would continue to provide consulting services, aiding the company's market expansion in the U.S. and Canada with DrugSorb-ATR. CytoSorbents has received significant funding and regulatory approvals, positioning itself as a leader in the medical device industry.
CytoSorbents Corporation (NASDAQ: CTSO) announces a new study demonstrating the effectiveness of CytoSorb in reducing cytokine storms during systemic inflammation, published in the medical journal Critical Care. Conducted by sepsis experts from Radboud University Medical Center, the study involved 24 healthy male volunteers given endotoxin. The CytoSorb treatment resulted in significant reductions of cytokines like TNF (58% reduction) and IL-6 (71% reduction). This study reinforces the role of CytoSorb in managing severe inflammation and supports its usage in critical care settings.
CytoSorbents Corporation (NASDAQ: CTSO) announced its participation in the 42nd International Symposium on Intensive Care & Emergency Medicine (ISICEM 2023) in Brussels, showcasing new data on CytoSorb therapy. Notable presentations include the ability of CytoSorb to reduce cytokine levels during systemic inflammation and prevent endothelial damage, crucial in managing septic shock. The symposium will feature live-streamed discussions on these studies, emphasizing CytoSorb's growing role in critical care. The company aims to connect with global clinicians and showcase the benefits of its blood purification technology in treating serious conditions.
CytoSorbents Corporation (NASDAQ: CTSO), a leader in blood purification technology, announced it has no direct financial exposure to Silicon Valley Bank or Signature Bank. The company maintains diversified cash holdings, primarily at JP Morgan Chase, and has a minority at Bridge Bank. CytoSorbents specializes in treating life-threatening conditions in critical care settings, with over 195,000 CytoSorb devices used globally. The company's product portfolio includes FDA and CE-marked technologies addressing severe inflammatory conditions and anticoagulant removal. CytoSorbents has received approximately $48 million in non-dilutive funding from various U.S. government agencies.
CytoSorbents Corporation (NASDAQ: CTSO) announced pivotal updates on its STAR-T trial, reporting enrollment has surpassed the halfway mark. Financial results for 2022 showed total revenue at $34.7 million, down 20% from $43.2 million in 2021, driven by a 27% drop in product sales. Core product sales fell 11% due to unfavorable currency exchange rates, but adjusted for currency, the decline was 4.6%. The company ended 2022 with cash and equivalents of $23.8 million. Despite challenges, management projects sales growth in 2023 from initiatives and improved market conditions, aiming to restore product margins to historical levels of 75-80%.
CytoSorbents Corporation (NASDAQ: CTSO) has been recognized in the new 2022 European Society of Anaesthesiology and Intensive Care guidelines for the management of severe perioperative bleeding. The guidelines recommend hemoadsorption of antithrombotic drugs, specifically ticagrelor and rivaroxaban, during emergency cardiac surgeries. This endorsement is seen as a critical validation of CytoSorb's blood purification technology, which is already CE mark approved in the EU. The company is also conducting a STAR-T clinical trial in the U.S. and Canada to further evaluate its DrugSorb-ATR system aimed at reducing bleeding complications in cardiothoracic surgery.
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