Cytosorbents Corp Stock Price, News & Analysis

CytoSorbents Corporation (NASDAQ: CTSO) has secured $5 million in non-dilutive debt financing from Bridge Bank, strengthening its balance sheet and providing working capital for key initiatives. This loan comes under a revised agreement allowing for a total loan commitment of $15 million, with the first tranche available immediately. The financing aims to support the U.S. STAR-T pivotal trial and commercial initiatives while extending the drawdown period for remaining funds to March 1, 2023. The loan has favorable terms, including no financial covenants and interest-only payments until January 1, 2024.

CytoSorbents Corporation (NASDAQ: CTSO) has received a recommendation from the independent Data and Safety Monitoring Board (DSMB) to continue its pivotal STAR-T trial without modifications. The trial evaluates DrugSorb-ATR's ability to reduce perioperative bleeding by removing the antithrombotic drug ticagrelor during cardiothoracic surgery. The trial aims to enroll 120 patients across 30 centers and is critical for FDA and Health Canada marketing approval. The company aims to enroll 80 patients by Spring 2023, marking a significant milestone in the study.

On November 14, 2022, CytoSorbents Corporation (NASDAQ: CTSO) announced it has enrolled 40 patients in the STAR-T trial, a pivotal study aimed at supporting FDA and Health Canada approval of DrugSorb-ATR. The trial seeks to enhance safety in patients undergoing cardiothoracic surgery who are on ticagrelor. As the first milestone is reached, a Data and Safety Monitoring Board review will follow. The company anticipates that the next milestone of 80 enrolled patients could be met by Spring 2023.

CytoSorbents Corporation (NASDAQ: CTSO) announced Q3 2022 results, reporting total revenues of $8.1 million, down 17% from Q3 2021. Product sales declined by 27% to $6.5 million, impacted by low COVID-related sales and unfavorable currency effects. Gross margins fell to 55% due to an inventory write-off and production inefficiencies. Despite challenges, the company achieved key milestones in its U.S. STAR-T trial, expecting to enroll 40 patients this month. Cash reserves stand at $24.2 million with no debt, as the company focuses on cost control and growth initiatives amidst ongoing market pressures.

CytoSorbents Corporation (NASDAQ: CTSO) announced positive results from the CytoSorb Therapy in COVID-19 (CTC) Registry presented at the ESICM Congress. The study involved 100 critically ill COVID-19 patients, showing 90-day survival rates of 74% compared to 52% in the broader ELSO registry. Early initiation of CytoSorb therapy significantly improved outcomes, with reduced inflammatory markers and shorter ECMO durations. The study highlights the efficacy of CytoSorb in addressing severe acute respiratory distress syndrome and supports further research into this treatment paradigm.

CytoSorbents Corporation (NASDAQ: CTSO) has been awarded a Phase I SBIR grant worth $281,835 from the National Institute of General Medical Sciences to advance its blood purification technologies targeting Gram-negative sepsis. This funding will facilitate research on the removal of cytokines and lipopolysaccharide (LPS) endotoxin from septic porcine plasma, critical in combating sepsis, responsible for one in five deaths globally. CEO Phillip Chan emphasized the importance of addressing Gram-negative infections in septic shock, which accounts for a significant portion of hospital-acquired infections.

CytoSorbents Corporation (NASDAQ: CTSO) is set to release its third quarter 2022 operating and financial results on November 3, 2022, after market close. A live conference call and presentation will follow at 4:30 p.m. Eastern. The company is recognized for its innovative blood purification technology aimed at critical conditions in ICU and cardiac surgery. CytoSorb, their leading product, is approved in the EU and used in over 75 countries. With over 179,000 devices utilized as of June 30, 2022, CytoSorb focuses on managing severe inflammatory responses in patients.

CytoSorbents Corporation (NASDAQ: CTSO) presented new data on CytoSorb® at the 36th EACTS Annual Meeting in Milan, highlighting its effectiveness in cardiac surgery. The study involved 130 patients undergoing surgery for Staphylococcal aureus endocarditis. The results showed that CytoSorb significantly reduced postoperative vasopressor requirements (p<0.02) and sepsis-related mortality (8.0% vs. 21.8%, p=0.02). Furthermore, it demonstrated significant improvements in 30-day (17.3% vs. 32.7%, p=0.03) and 90-day mortality (21.3% vs. 40%, p=0.03), emphasizing its potential as a safe therapy in high-risk cardiac surgeries.

CytoSorbents Corporation (NASDAQ: CTSO) announced the upcoming retirement of CFO Kathleen P. Bloch on March 31, 2023, after a decade of service. Bloch will assist as a consultant post-retirement to ensure a smooth transition. Under her leadership, the company raised over $140 million and expanded globally, distributing products in 75 countries. CEO Phillip Chan praised her contributions, which included significant improvements in accounting and investor relations. The company aims for continued growth and FDA approval for its DrugSorb-ATR system.