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Cytosorbents (CTSO) investor relations material
Cytosorbents Jefferies London Healthcare Conference 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Technology and product overview
Platform blood purification technology removes toxins and harmful substances from blood, with plug-and-play compatibility for hospital blood pump infrastructure.
CytoSorb, the flagship product, is EU-approved, with nearly 300,000 treatments in over 70 countries and 71% product gross margins.
DrugSorb-ATR, an investigational device, targets bleeding in patients on blood thinners during cardiac surgery and holds two FDA breakthrough device designations.
The technology is protected by 22 issued U.S. patents and has received about $50 million in U.S. government grants.
CytoSorb removes a broader range of harmful substances than dialysis, including large molecules and fat-soluble drugs.
Clinical applications and market opportunity
CytoSorb addresses severe inflammation in critical illnesses, targeting conditions like sepsis, burn injury, liver failure, and cardiac surgery complications.
Potential to treat 40%-60% of ICU patients, a much larger market than chronic kidney disease.
Sepsis accounts for roughly half of all treatments, representing a significant global market.
DrugSorb-ATR addresses a $1 billion U.S. market by enabling urgent surgery for patients on blood thinners without delay.
The device can remove multiple classes of blood thinners, including Brilinta, ELIQUIS, and XARELTO.
Regulatory and commercialization strategy
DrugSorb-ATR's initial De Novo FDA submission was denied due to efficacy data gaps, but most issues have been resolved through collaborative discussions.
FDA found no safety concerns and agreed to limit the new De Novo review to remaining open items, streamlining the process.
A new De Novo submission is planned for Q1 2026, with a regulatory decision anticipated by mid-2026.
Commercialization in the U.S. will use a direct sales model, starting with a controlled market release and a small, regionally focused sales force.
The company is eligible for NTAP and TCET reimbursement programs, supporting market adoption.
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