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 products approved in the EU and distributed in over 70 countries.

• CytoSorb is CE mark approved for cytokine, bilirubin, myoglobin, and blood thinner removal, with over 300,000 treatments performed globally.

• Strategic partnerships with Fresenius, B. Braun, and Terumo Cardiovascular support integration with existing hospital infrastructure.

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

• 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.

• CytoSorb addresses severe inflammation, a key factor in organ failure and mortality in critical illnesses like sepsis, trauma, and cardiac surgery.

• Supported by extensive clinical data and real-world evidence, especially in sepsis and perioperative bleeding risk reduction.

• DrugSorb-ATR aims to address urgent surgical needs for patients on blood thinners, reducing delays and bleeding complications.

• STAR-T pivotal trial showed significant reduction in perioperative bleeding for CABG patients, with FDA review focused on mechanistic data.

Regulatory and development milestones

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

• Anticipates new De Novo application submission in late 2026 or early 2027, with a potential 150-day FDA review period.

• Real-world evidence continues to build for both BRILINTA and DOACs, supporting market expansion.

• 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.