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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 the FDA's full approval of its Investigational Device Exemption (IDE) for the STAR-D trial, aimed at evaluating the DrugSorb-ATR system's efficacy in removing direct oral anticoagulants (DOACs) during urgent cardiothoracic surgery. The trial targets up to 120 patients across 25 sites and is a pivotal step in supporting FDA marketing approval. This follows the FDA's Breakthrough Device Designation for the DrugSorb-ATR system, which addresses a significant market need in a potential $1 billion U.S. market for DOAC removal during surgeries.
CytoSorbents Corporation (NASDAQ: CTSO) announced preliminary Q3 2021 financial results reflecting a total revenue of $9.7 million, down 8% year-over-year. CytoSorb product sales were $8.9 million, a 13% decline, driven mainly by adverse pandemic conditions in Germany, which saw a significant drop in elective surgeries and COVID-19 related sales. The company revised its 2021 product revenue guidance, anticipating Q4 product revenue to match Q3 levels. Despite challenges, CytoSorbents maintains a strong cash position of $61 million and focuses on diversifying revenue streams.
CytoSorbents Corporation (NASDAQ: CTSO) has announced preliminary data from two endocarditis studies, including the REMOVE study, to be presented at the EACTS annual meeting in Barcelona from October 13-16, 2021. The REMOVE study, involving 288 patients, showed that while hemoadsorption using CytoSorb reduced plasma cytokines, it did not decrease post-operative organ dysfunction or mortality rates. A separate retrospective study found CytoSorb use correlated with lower sepsis-related mortality. However, both studies are preliminary, and further analysis is expected.
CytoSorbents Corporation (NASDAQ: CTSO) will host a live webinar on September 16, 2021, at 11 a.m. EDT to discuss the use of CytoSorb blood purification therapy in critically ill COVID-19 patients. The webinar will present data from seven studies on over 215 patients, showcasing a 73% survival rate in a U.S. multicenter registry utilizing CytoSorb with ECMO. Notable clinical outcomes include reductions in inflammatory markers and improvements in lung function. This therapy aims to mitigate cytokine storms and enhance survival chances in severe cases.
CytoSorbents Corporation (NASDAQ: CTSO) commemorated World Sepsis Day and Sepsis Awareness Month with several key initiatives, including sponsorships and studies related to its blood purification technology, CytoSorb. This product aims to combat severe inflammation caused by sepsis, a critical health issue linked to one in five deaths globally. The company announced the upcoming PROCYSS trial in Germany to evaluate CytoSorb's effectiveness in treating refractory septic shock, highlighting its potential in saving lives in high-risk patients.
CytoSorbents Corporation (NASDAQ: CTSO) has filed an Investigational Device Exemption (IDE) application with the FDA for the STAR-D clinical study, targeting the removal of direct oral anticoagulants apixaban and rivaroxaban during urgent cardiothoracic surgery. This follows the FDA's Breakthrough Device Designation granted in August 2021, acknowledging the unmet medical need to reduce severe bleeding risks in patients on these medications. CytoSorbents aims to address a U.S. market potential of one billion dollars for this application.
CytoSorbents Corporation (NASDAQ: CTSO) will host a webinar on September 13, 2021, at 5:00 p.m. EDT to discuss the topline results from its U.S. CTC Multicenter Registry. The registry studied 52 critically ill COVID-19 patients with ARDS on ECMO using CytoSorb, highlighting survival rates. Dr. Phillip Chan, CEO, will lead the session, which includes a review of the results by Dr. J. W. Awori Hayanga. Registration is available online, and the session will be accessible for later viewing.
CytoSorbents Corporation (NASDAQ: CTSO) announced promising results from its CytoSorb Therapy in COVID-19 (CTC) registry presented at the ISICEM 2021 symposium. The study included 52 critically ill COVID-19 patients and reported a 90-day ICU mortality rate of 27%, significantly lower than the 50% mortality observed in similar patients in the ELSO Registry. All participating centers noted the CytoSorb device was easily integrated with ECMO and had no unanticipated adverse events, indicating its potential as a life-saving therapy.
On August 12, 2021, CytoSorbents Corporation (NASDAQ: CTSO) announced that the FDA granted a second Breakthrough Device designation for its DrugSorb-ATR Antithrombotic Removal System. This designation covers the removal of Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban during urgent cardiothoracic surgeries, aiming to reduce life-threatening bleeding risks. This milestone supports the company's U.S. strategy and highlights a potential market exceeding $500 million. The system addresses a significant unmet medical need, especially as the population using these anticoagulants grows.
CytoSorbents Corporation (NASDAQ: CTSO) announced its Q2 2021 results, reporting total revenue of $12.0 million, a 23% increase from $9.8 million in Q2 2020. Core non-COVID-19 product sales surged 38% to a record $9.7 million. Gross profit reached $9.3 million with margins at 82%. The company has FDA approval for the STAR-T trial aimed at gaining marketing approval for its DrugSorb-ATR system. CytoSorbents expects at least 30% year-over-year growth in core product sales for the remainder of 2021, with limited COVID-19-related sales anticipated.
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