Cytosorbents (CTSO) Jefferies London Healthcare Conference 2025 summary

Technology and Product Overview

• Blood purification technology removes toxins and harmful substances, with plug-and-play compatibility for hospital blood pump infrastructure and nearly 300,000 treatments in over 70 countries.

• CytoSorb, the core product, is EU-approved, targets life-threatening ICU and cardiac surgery conditions, and achieves 71% gross margins.

• DrugSorb-ATR, an investigational device for reducing perioperative bleeding in patients on blood thinners, holds two FDA breakthrough device designations and is pursuing De Novo approval.

• 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, using polymer bead technology.

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 up to 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-plus 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.