SeaStar Medical Holding Corporation

SeaStar Medical Holding Corporation reported second-quarter 2026 net revenue of $615,000, an 82% increase year over year driven by expanded adoption of its QUELIMMUNE therapy for pediatric acute kidney injury. Six-month net revenue reached $1.1 million, keeping the company on track toward its full-year target of $2 million, while gross margin held at 91%. The company has doubled its hospital customer base to 20 of the 50 premier children's hospitals in the U.S. since the start of 2026, with a year-end goal of 25 hospitals. Enrollment in the NEUTRALIZE-AKI pivotal trial for adult patients reached 223 of 339 targeted patients, with completion expected between the fourth quarter of 2026 and the first quarter of 2027, and a modular PMA submission to the FDA remains targeted for late 2027. Net loss for the quarter was $3.7 million, or $0.91 per share, compared with a net loss of $2.0 million in the prior-year period, and cash and cash equivalents stood at $7.0 million as of June 30, 2026.

SeaStar Medical is sponsoring a KidneyBee Summit and an educational webinar to advance treatment of pediatric acute kidney injury. The KidneyBee Summit 2026 takes place at Children’s Hospital Colorado from July 14 to 16, bringing together nurses, advanced practice providers, and physicians to address systemic failures in recognizing pediatric kidney failure. The webinar, titled Rethinking Pediatric Sepsis-Associated AKI: What Clinicians Should Know About QUELIMMUNE, will be held on August 11, 2026, and will focus on the company’s QUELIMMUNE therapy, a first-in-class device that neutralizes overactive immune cells to stop destructive hyperinflammation. Data from clinical trials showed a 77% survival rate with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data. Real-world data from the QUELIMMUNE SAVE Registry showed a 76% survival rate at Day 28 and Day 60 in the first 21 pediatric patients, with no device-related adverse events.

Can-Fite BioPharma, SeaStar Medical, and Elicio Therapeutics were among the top biotech gainers on Wednesday. Can-Fite soared over 55% after its Phase 2a pancreatic cancer study with Namodenoson met its primary safety endpoint and showed durable overall survival, prompting plans for a Phase 2b combination trial. SeaStar Medical jumped more than 30% as net revenue for its flagship QUELIMMUNE pediatric therapy rose to approximately $0.5 million in the first quarter of 2026 from $0.3 million a year earlier, with full-year 2026 product revenue expected to reach about $2 million. Elicio Therapeutics climbed over 31% following its addition to the Russell 2000 and Russell 3000 Indexes and the refinement of its Phase 3 development strategy for ELI-002, despite the Phase 2 AMPLIFY-7P trial missing its primary endpoint. Regentis Biomaterials gained more than 29% as it prepares to begin European surgeon training for its CE Mark-approved knee cartilage implant GelrinC. TransCode Therapeutics rose over 20% for a second straight day, with a Phase 2a trial of its metastatic cancer therapy TTX-MC138 underway and preliminary results expected in the fourth quarter of 2026. Outset Medical advanced over 18% after reporting first-quarter 2026 revenue of $27.9 million and projecting full-year revenue between $125 million and $130 million.