Cytosorbents (CTSO) H.C. Wainwright 28th Annual Global Investment Conference summary

Company overview and product pipeline

• Specializes in blood purification devices for critical care and cardiac surgery, commercialized in 75 countries with over 300,000 treatments performed.

• Flagship product CytoSorb generated $37.3 million in sales over the past 12 months with 73% gross margins in Q2.

• Nearing cash flow break even, expected in the second half of this year, with profitability targeted soon after.

• DrugSorb-ATR, designed to remove blood thinners during surgery, is planned for a de novo FDA submission early next year, targeting approval by mid-2027.

• HemoDefend, a universal blood product filter, is entering human clinical trials, aiming to simplify transfusions and improve emergency response.

Commercial performance and restructuring

• Hybrid sales model: direct in 10 EU countries, distributor partnerships in 65 others; Germany accounts for 25% of sales.

• Germany underwent a >30% organizational reduction and sales process overhaul, now rebuilding for renewed growth.

• Distributor sales grew 16% and direct sales outside Germany grew 9% last quarter.

• New Dubai subsidiary launched for MENA region; modest sales expected in the second half of the year, with stronger growth anticipated in 2027.

• Production capacity in New Jersey is sufficient to support both current growth and future DrugSorb-ATR launch.

DrugSorb-ATR market opportunity and regulatory pathway

• Addresses unmet need for rapid blood thinner removal in emergent cardiac surgery, where no antidote exists and bleeding risk is high.

• STAR-T trial showed 58% reduction in serious/fatal bleeding; real-world data from ESC conference confirmed similar benefits with a 37% reduction.

• Combined data from about 250 patients will be submitted to FDA, with Breakthrough Device designation and no major safety concerns identified.

• Mechanistic data still being collected; de novo submission targeted for early next year, with potential FDA decision by mid-year.

• Parallel submission planned for use with DOACs, following positive FDA discussions.