Cytosorbents (CTSO) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Key product and technology updates

• Preparing to submit DrugSorb-ATR for FDA and Health Canada approval next month, targeting perioperative bleeding in CABG patients on Brilinta, with a $650M addressable market in the US and Canada.

• CytoSorb blood purification cartridge is commercialized in 76 countries, with $37.2M in trailing 12-month revenue and 75% product gross margins.

• Over 250,000 CytoSorb devices used globally, supported by 1,000+ publications and $50M in grants from US agencies.

• Technology removes a broad range of toxins, including cytokines, bilirubin, and blood thinners, and is compatible with existing hospital blood pump infrastructure.

• 22 issued US patents and manufacturing at an ISO 13485 certified facility in New Jersey.

Clinical and market positioning

• CytoSorb targets life-threatening inflammation and toxin overload in ICU and cardiac surgery, addressing conditions like sepsis, ARDS, liver failure, and trauma.

• Strategic partnerships with Fresenius, B. Braun, and Terumo Cardiovascular expand reach in dialysis and cardiac surgery markets.

• Business model leverages plug-and-play compatibility with dialysis, ECMO, and heart-lung machines, differentiating from traditional dialysis by removing larger, fat-soluble toxins.

• Riding demographic trends such as aging populations and increased use of blood thinners, which drive demand for critical care solutions.

• Only reversal agent for blood thinners in cardiac surgery outside the US and Canada; DrugSorb-ATR has two FDA breakthrough device designations.

Clinical trial and regulatory progress

• STAR-T pivotal trial for DrugSorb-ATR completed: 140-patient, 30-center study in US and Canada for CABG patients on Brilinta.

• No safety concerns observed; severe bleeding endpoint met in CABG per-protocol population.

• DrugSorb-ATR associated with reduced bleeding severity and favorable benefit-to-risk profile; number needed to treat to avoid a major bleed is six.

• Regulatory submissions to FDA and Health Canada planned for this quarter.

• Market opportunity could double by expanding to other blood thinners and reach $2.2B if applied to all surgeries in US and Canada.