Cytosorbents (CTSO) Life Sciences Virtual Investor Forum summary

Business Overview and Technology

• Specializes in blood purification for critical care and cardiac surgery using proprietary polymer bead technology, with CytoSorb CE-marked in the EU and distributed in over 70 countries; over 300,000 treatments performed globally.

• CytoSorb removes cytokines, bilirubin, myoglobin, and blood thinners, with products compatible with existing hospital blood pump infrastructure.

• Strategic partnerships with Fresenius, B. Braun, Terumo Cardiovascular, and government support have provided ~$50M in non-dilutive funding.

• Product portfolio includes CytoSorb, ECOS-300CY, VetResQ, PuriFi, HotSwap, and HemoDefend-BGA, with a deep pipeline for future growth and next-generation products.

• Holds 20 issued U.S. patents and multiple international patents, reinforcing innovation leadership.

Market Opportunity and Clinical Impact

• Targets 40%-60% of ICU patients with life-threatening inflammation or toxin overload, a much larger market than traditional dialysis.

• Large total addressable market estimated at $1-2 billion, with near-term opportunities exceeding $600M in North America.

• Supported by extensive clinical data, including the international COSMOS registry and peer-reviewed studies showing improved outcomes in sepsis and cardiac surgery.

• DrugSorb-ATR aims to address urgent surgical needs for patients on blood thinners, reducing delays and bleeding complications; STAR-T pivotal trial showed safety and reduced severe bleeding in CABG patients, though primary efficacy endpoint was not met overall.

• Pipeline includes expanded indications such as DOAC removal, with additional FDA Breakthrough Device Designations.

Regulatory and Development Milestones

• CytoSorb is CE-marked in Europe but not yet FDA or Health Canada approved; DrugSorb-ATR is investigational in North America.

• DrugSorb-ATR is in the FDA approval process, with pre-submission meetings scheduled for late 2026/early 2027 to discuss mechanistic data and parallel De Novo submissions for BRILINTA and DOAC indications.

• FDA appeal upheld prior denial for DrugSorb-ATR but outlined a path for resubmission based on real-world evidence and mechanistic data.

• HemoDefend-BGA, developed with DoD funding, aims to create universal blood products for any patient.

• Expects clinical trials for new products by 2027, following FDA pre-IDE feedback.