PRINCETON – CytoSorbents Corporation (NASDAQ:CTSO), known for its blood purification technologies, has announced that its STAR-T trial results will be presented at the upcoming 104th Annual Meeting of the American Association for Thoracic Surgery (AATS) in Toronto, Canada. The presentation of the Safe and Timely Antithrombotic Removal of Ticagrelor (STAR-T) study, a pivotal randomized controlled trial, is scheduled for April 28, 2024.
The STAR-T trial investigated the intraoperative use of DrugSorb-ATR, a device designed to reduce bleeding risks associated with ticagrelor during urgent cardiac surgery. The trial involved 140 patients across roughly 30 centers in the U.S. and Canada. CytoSorbents aims to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR with this study.
CytoSorbents' flagship product, CytoSorb, is utilized in the intensive care and cardiac surgery settings to remove inflammatory mediators and antithrombotic drugs from the bloodstream. CytoSorb has been approved in the European Union and is available in 75 countries, with over 228,000 units used by the end of 2023. The technology is based on polymer beads capable of removing toxic substances from bodily fluids.
The company has also been granted FDA Emergency Use Authorization in the United States for CytoSorb to treat adult critically ill COVID-19 patients with respiratory failure. Additionally, the DrugSorb-ATR system has received FDA Breakthrough Device Designations for removing ticagrelor and direct oral anticoagulants in urgent cardiothoracic procedures.
Following the AATS presentation, a Virtual KOL and Investor Day is set for May 6th to review the STAR-T trial results, with discussions on real-world usage of CytoSorb, which is already approved in the European Union for similar applications.
This news is based on a press release statement from CytoSorbents Corporation.
InvestingPro Insights
As CytoSorbents Corporation (NASDAQ:CTSO) gears up to present their pivotal STAR-T trial results, investors and analysts are closely watching the company's financial health and market performance. The InvestingPro data reveals a market capitalization of $43.31M, indicating a smaller cap company with potential growth opportunities, yet also higher volatility and risk.
The revenue growth over the last twelve months has been modest at 4.79%, showing some level of business expansion. However, the quarterly revenue growth shows a contraction of -7.69%, suggesting potential challenges in the company's recent operations. With a gross profit margin of 61.6%, the company maintains a strong ability to retain earnings from sales after accounting for the cost of goods sold, which is a positive indicator of financial health in its operational efficiency.
InvestingPro Tips highlight some challenges for CytoSorbents, as analysts do not expect the company to be profitable this year, and it has been operating with a moderate level of debt. These factors, coupled with the fact that the company does not pay a dividend, may influence investment decisions. Moreover, the price has seen a significant decrease over the last year, with a -69.55% return, which could be a concern for existing and potential shareholders.
For investors seeking a more comprehensive analysis, InvestingPro offers additional insights and metrics on CytoSorbents Corporation. Interested readers can explore these by visiting https://www.investing.com/pro/CTSO and can take advantage of a special offer using the coupon code PRONEWS24 for an additional 10% off a yearly or biyearly Pro and Pro+ subscription. There are 5 more InvestingPro Tips available, which could provide further clarity on the company's financial outlook and investment potential.
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