SeaStar Medical demonstrated strong sequential growth in the first quarter of 2025, with QUELIMMUNE sales increasing fourfold to $293,000 and the company positioning itself to enter the expansive adult acute kidney injury (AKI) market.
The company's breakthrough product, QUELIMMUNE, is currently FDA-approved for pediatric patients with life-threatening AKI due to sepsis. While the pediatric market represents approximately 4,000 patients annually, SeaStar is targeting the substantially larger adult AKI market, estimated at $4.5 billion annually.
The company's NEUTRALIZE-AKI pivotal trial, evaluating its Selective Cytopheretic Device (SCD) therapy in adult patients, has reached 50% enrollment. If successful, SeaStar anticipates filing for adult AKI market approval in 2026, potentially transforming treatment options for critically ill patients.
Beyond sales growth, SeaStar reported narrowing its net loss to $3.8 million in the first quarter and ending the period with $5.3 million in cash. The company has also received two additional Breakthrough Device Designations, bringing its total to six therapeutic indications.
CEO Eric Schlorff emphasized the company's commitment to improving patient outcomes, noting that QUELIMMUNE offers organ-sparing and potentially life-saving treatment for critically ill pediatric patients. The company is now focused on expanding its customer base and preparing for potential adult market entry.
