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GlobeNewswire·

SeaStar Medical Reports Third Quarter 2026 Financial Results and Provides Business Updates

ICU
  • SeaStar Medical reported a 247% increase in net revenue to $635,000 for the third quarter of 2026 compared to the same period in 2025, driven by adoption of QUELIMMUNE therapy.
  • Gross profit margins remained above 90% for the quarter.
  • Research and development expenses rose to $3.6 million from $1.9 million year-over-year, primarily due to increased clinical research activities for the NEUTRALIZE-AKI trial.
  • General and administrative expenses decreased to $1.6 million from $1.9 million, resulting from lower personnel, legal, audit, and SEC-related costs.
  • The company reported a net loss of $4.5 million, or $1.03 per share, for the three months ended September 30, 2026, compared to a net loss of $3.5 million in the prior year period.
  • Cash on hand was $4.0 million as of September 30, 2026, excluding $3.3 million in gross proceeds from warrant exercises that occurred in October 2026.
  • The NEUTRALIZE-AKI pivotal clinical trial for adult acute kidney injury patients is nearly 75% enrolled with 251 of 339 patients enrolled to date.
  • Real-world data presented at ASN Kidney Week 2026 showed statistically significant higher survival for QUELIMMUNE-treated pediatric patients versus comparator cohorts at Day 60, Day 90, and hospital discharge.
  • SeaStar Medical fulfilled FDA post-approval requirements for the SAVE Registry study, enabling hospitals to use QUELIMMUNE without the previous research infrastructure.
  • The company submitted the first module of a modular premarket approval application to the FDA for the SCD therapy as a treatment for adults with AKI receiving CRRT.
  • The FDA granted Breakthrough Device Designation for the SCD therapy for treating hyperinflammation in adult patients with sepsis, marking the seventh such designation for the technology.
  • CMS granted dedicated ICD-10-PCS codes for the SCD therapy effective October 1, 2026, to facilitate billing for inpatient hospital use.
  • The company expects to complete enrollment in the NEUTRALIZE-AKI trial by mid-year 2027.
Company
SeaStar Medical
Keywords
Nasdaq:ICU, SeaStar Medical, 3Q financial results, NEUTRALIZE-AKI, QUELIMMUNE, pediatric aki, acute kidney injury, AKI, ICD-10-PCS, breakthrough device grant, BDD