Cytosorbents Corp Stock Price, News & Analysis

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.

CytoSorbents Corporation (NASDAQ: CTSO) will present at the Cowen 43rd Annual Health Care Conference on March 7, 2023, from 1:30 PM to 2:00 PM EST at the Boston Marriott Copley Place. CEO Phillip Chan will lead the presentation, focusing on the company's blood purification technologies for life-threatening conditions. CytoSorb®, their flagship product, is approved in the EU and used in over 75 countries. The company is also seeking FDA approval for DrugSorb™-ATR, aimed at removing antithrombotic drugs during surgery. The STAR-T clinical trial is ongoing to evaluate efficacy in reducing bleeding risks.

CytoSorbents Corporation (NASDAQ: CTSO) announced it will report its fiscal 2022 financial results on March 9, 2023, at 4:30 PM EST. The company, focused on blood purification technology for critical care and cardiac surgery, is set to provide insights into its operational and financial progress during Q4 2022 and the full fiscal year. CytoSorbents’ flagship product, CytoSorb®, is approved in the EU and used worldwide, with over 195,000 devices utilized to date. The press release details a conference call for stakeholders to discuss these results, which will also be available as an archived recording on the company's website.

CytoSorbents Corporation (CTSO) reported a total revenue of approximately $34.7 million in 2022, down from $43.2 million in 2021. Cumulative CytoSorb treatments exceeded 195,000, marking a 20% increase year-over-year. Q4 2022 product sales reached approximately $7.6 million, up 18% sequentially from Q3 2022 but lower than Q4 2021 due to COVID-related sales. The company aims to complete the pivotal STAR-T trial for its DrugSorb-ATR product in 2023, targeting the U.S. and Canadian markets, with a significant addressable market estimated at $300-350 million. The firm ended 2022 with a solid cash balance of $23.8 million and a grant backlog of $11.5 million.

On January 23, 2023, CytoSorbents Corporation (NASDAQ: CTSO) announced that it has received regulatory approval from Health Canada to include Canadian sites in its pivotal STAR-T trial. This trial focuses on the removal of ticagrelor during cardiac surgery to minimize bleeding risks. Dr. Richard Whitlock emphasized the study's importance for Canadian cardiac surgery centers, anticipating high-volume patient recruitment. CytoSorbents aims to reach its enrollment milestone of 80 patients by Spring 2023 and full enrollment of 120 patients by Summer 2023. The STAR-T trial is critical for FDA and Health Canada marketing approval of the DrugSorb-ATR system.

CytoSorbents (NASDAQ: CTSO) has appointed Dr. Irina Kulinets as Senior Vice President of Global Regulatory Affairs, focusing on FDA marketing approval for DrugSorb®-ATR. With over 30 years of regulatory experience in medical devices and clinical research, Dr. Kulinets aims to leverage her expertise to expedite the approval process for innovative therapies. Previously, she held senior roles at MicroVention and several major life science companies. This leadership change comes at a crucial time as the company approaches significant trial conclusions that could enhance its product offerings in the U.S. and Canada.

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.