Cytosorbents Corp Stock Price, News & Analysis

CytoSorbents Corporation (NASDAQ: CTSO) has announced the enrollment of the first patient in its STAR-T trial, a pivotal study aimed at obtaining FDA approval for the DrugSorb-ATR™ system. This double-blind, randomized, controlled trial will evaluate the system's efficacy in removing the antiplatelet drug ticagrelor during cardiothoracic surgery to mitigate bleeding risks. The STAR-T trial received full FDA IDE approval in July 2021 and aims to enroll 120 patients across 20 sites, expected to finish by 2022. The initiative addresses a critical medical need in cardiac surgery.

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.