Cytosorbents (CTSO) Investor presentation summary

Business overview and technology

• Specializes in blood purification for critical care and cardiac surgery using proprietary polymer bead technology, with over 300,000 treatments in 70+ countries and CE Mark approval in the EU.

• CytoSorb removes cytokines, bilirubin, myoglobin, and blood thinners, targeting conditions like sepsis, liver failure, and surgical complications.

• Products are compatible with existing hospital blood pump infrastructure, including dialysis, ECMO, and CPB.

• Supported by extensive clinical data, including real-world registries and peer-reviewed studies.

• Strategic partnerships and ~$50M in non-dilutive government funding support ongoing development.

Financial performance and commercialization

• Achieved $37.3M in trailing twelve-month sales as of June 2026, with 72–73% gross margins.

• Core sales CAGR of 26% from 2017–2021, with $37.1M in 2025 sales and strong growth in critical care and cardiac surgery markets.

• Q2 2026 cash burn was $200K (excluding restructuring), with a 27% improvement in operating loss and 38% improvement in adjusted EBITDA.

• Operating cash flow breakeven targeted for 2H 2026, supported by cost reductions and a 23% headcount reduction since September 2025.

• Sales are diversified geographically, with direct sales in Germany and nine other countries, and distributor partnerships elsewhere.

Product pipeline and regulatory status

• CytoSorb is CE Mark approved in Europe for cytokine, bilirubin, myoglobin, and blood thinner removal, but not yet FDA or Health Canada approved.

• DrugSorb-ATR is an investigational device for reducing perioperative bleeding in cardiac surgery patients on blood thinners, with two FDA Breakthrough Designations.

• STAR-T pivotal RCT showed DrugSorb-ATR is safe and reduces major bleeding in CABG patients operated within 2 days of ticagrelor discontinuation.

• Planning a second De Novo FDA submission for DrugSorb-ATR in Q1 2027, with potential marketing approval by mid-2027.

• HemoDefend-BGA is a preclinical filter platform for universal blood products, supported by $16M in non-dilutive funding and positive FDA engagement.