Recent Updates — ICUCW

The U.S. Food and Drug Administration has determined that the QUELIMMUNE Pediatric SAVE Surveillance Registry has fulfilled all post-approval study requirements outlined in the original Humanitarian Device Exemption approval for QUELIMMUNE. This regulatory confirmation allows hospitals to employ the therapy without the research infrastructure previously mandated by the registry, thereby expanding access to critically ill pediatric patients with sepsis-associated acute kidney injury requiring renal replacement therapy. The decision follows data presented at ASN Kidney Week 2026 showing a statistically significant improvement in 90-day survival for treated patients compared to historical cohorts. SeaStar Medical Holding Corporation is a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life.

SeaStar Medical Holding Corporation reported financial results for the second quarter ended June 30, 2026. Net revenue increased 82% to $0.6 million from $0.3 million in the prior year period, driven by QUELIMMUNE product sales. The company incurred a net loss of $3.7 million, or $0.91 per share, compared to a $2.0 million loss in the same quarter last year. Cash reserves declined to $7.0 million from $12.0 million at year-end 2025. Research and development expenses rose to $2.5 million due to clinical trial costs, while general and administrative expenses increased to $1.8 million. The company added three new pediatric hospital customers for its QUELIMMUNE therapy and advanced enrollment in the NEUTRALIZE-AKI pivotal trial to 223 of 339 patients. CMS issued dedicated ICD-10-PCS codes for SCD therapy, effective October 1, 2026. SeaStar Medical is a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure.