SeaStar Medical (ICU) Biotech Showcase 2026 summary

Mission and clinical focus

• Aims to stop organ failure and save lives by addressing hyperinflammation, especially in ICU settings.

• Six FDA Breakthrough Device designations achieved for a single device platform.

• Lead product QUELIMMUNE targets pediatric acute kidney injury (AKI) with sepsis, with plans to expand to adult and other indications.

• Platform approach includes pipeline for adult AKI, cardiorenal syndrome, chronic dialysis, hepatorenal, and cardiac surgery.

• Unique mechanism deactivates neutrophils and monocytes to resolve cytokine storms without immunosuppression.

Market strategy and commercialization

• Initial U.S. pediatric AKI market estimated at $100 million, with adult market 50 times larger.

• Commercial launch in Q3 2024, targeting top 50 children’s hospitals, aiming for 20–25 customers by end of 2026.

• Registry requirement for HDE reduced from 300 to 50 patients, expected to accelerate adoption.

• Hospitals save $39,000–$46,000 per patient by reducing ICU time and mortality, making the product financially attractive.

• No reimbursement code required for pediatric use; adult use will have CMS reimbursement.

Clinical data and outcomes

• QUELIMMUNE increased pediatric survival rates by 50%–77% and eliminated long-term dialysis dependency in clinical studies.

• Post-market registry data confirmed clinical trial results, even in sicker patient populations.

• Zero device-related serious adverse events or infections reported.

• Adult pivotal study (NEUTRALIZE-AKI) underway with 339 patients, endpoints are all-cause mortality and dialysis dependency.

• Study includes top academic and community hospitals, aiming for broad applicability.