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Cytosorbents (CTSO) investor relations material
Cytosorbents H.C. Wainwright 27th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.H.C. Wainwright 27th Annual Global Investment Conference summary8 Sep, 2025
Technology and product overview
Blood purification platform removes toxins and harmful substances using a proprietary polymer bead technology, with two main products: CytoSorb and DrugSorb-ATR.
CytoSorb is CE-marked, used in over 70 countries, and has achieved record sales and high gross margins.
DrugSorb-ATR targets perioperative bleeding in cardiac surgery, with two FDA Breakthrough Device designations and ongoing regulatory discussions.
The technology addresses a $300 million market, potentially growing to over $1 billion, and is supported by 22 U.S. patents and $50 million in government grants.
CytoSorb targets a broader ICU patient base than dialysis, addressing critical illnesses driven by inflammation.
Clinical evidence and real-world data
CytoSorb controls massive inflammation in critical illnesses such as sepsis, trauma, and cardiac surgery, impacting up to 60% of ICU patients.
Registry and peer-reviewed studies show significant improvements in blood pressure, vascular leakage, lung function, and reduced mortality when used early and intensively.
A meta-analysis of 744 septic shock patients demonstrated reduced in-hospital and 28–30 day mortality with CytoSorb.
Real-world data from the COSMOS Registry and other studies support the effectiveness of CytoSorb in septic shock.
DrugSorb-ATR enables urgent cardiac surgery for patients on blood thinners, reducing severe bleeding and transfusion needs.
Regulatory and market updates
DrugSorb-ATR received FDA and Health Canada denials due to data deficiencies, but no safety issues were found; both agencies proposed paths forward for approval.
The company is actively engaging with regulators and has filed for reconsideration in Canada, focusing on addressing outstanding concerns.
DrugSorb-ATR is already indicated for use in Europe, with real-world data and awards supporting its impact.
The company remains committed to achieving North American approval and believes in the favorable benefit-risk profile of DrugSorb-ATR.
DrugSorb-ATR: FDA's specific path forward
CytoSorb: Germany growth strategy details
Core business break-even without DrugSorb-ATR?
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Next Cytosorbents earnings date
Q3 20256 Nov, 2025
Next Cytosorbents earnings date
Q3 20256 Nov, 2025
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Frequently asked questions
Cytosorbents Corporation is a medical device company specializing in blood purification technologies. The company develops and markets the CytoSorb adsorber, a device designed to reduce harmful substances such as cytokines, toxins, and metabolic waste from the bloodstream. These technologies are used in critical care and cardiac surgery applications to manage conditions like sepsis, inflammation, and organ failure. The company is headquartered in Princeton, New Jersey, and its shares are listed on the NASDAQ.
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