Cytosorbents (CTSO) H.C. Wainwright 27th Annual Global Investment Conference summary

Technology and Product Overview

• Blood purification platform uses proprietary polymer bead technology, with CytoSorb and DrugSorb-ATR as main products, removing toxins and harmful substances.

• CytoSorb is CE-marked, approved in the EU, used in over 70 countries, and has achieved record sales and high gross margins, with nearly 300,000 devices utilized.

• DrugSorb-ATR targets perioperative bleeding in cardiac surgery, has two FDA Breakthrough Device designations, and is supported by ongoing regulatory discussions.

• The technology addresses a $300 million market, potentially growing to over $1 billion, supported by 22 U.S. patents and over $50 million in government grants and non-dilutive funding.

• CytoSorb targets a broader ICU patient base than dialysis, addressing critical illnesses driven by inflammation.

Clinical Evidence and Real-World Data

• CytoSorb controls massive inflammation in critical illnesses such as sepsis, trauma, and cardiac surgery, impacting up to 60% of ICU patients.

• Registry and peer-reviewed studies, including COSMOS data from 150 patients, show significant improvements in blood pressure, vascular leakage, lung function, and reduced mortality when used early and intensively.

• A meta-analysis of 744 septic shock patients demonstrated reduced in-hospital and 28–30 day mortality with CytoSorb, with improved hemodynamics.

• Real-world data and comparative studies support CytoSorb's effectiveness in septic shock and reduced severe bleeding and transfusion needs in CABG patients on Brilinta.

• DrugSorb-ATR enables urgent cardiac surgery for patients on blood thinners, reducing severe bleeding and transfusion needs.

Regulatory and Market Updates

• DrugSorb-ATR received FDA and Health Canada denials due to data deficiencies, but no safety issues were found; both agencies proposed paths forward for approval.

• The company is actively engaging with regulators, has filed for reconsideration in Canada, and is focusing on addressing outstanding concerns.

• DrugSorb-ATR is already indicated for use in Europe, with real-world data and awards supporting its impact.

• Ongoing constructive discussions with FDA and Health Canada, with updates expected soon.

• The company remains committed to achieving North American approval and believes in the favorable benefit-risk profile of DrugSorb-ATR.