SeaStar Medical Holding Corporation

What they do

SeaStar Medical makes the Selective Cytopheretic Device (SCD), a disease-modifying device intended to neutralize over-active immune cells and stop the hyperinflammatory 'cytokine storm' in critically ill patients with organ failure. Its pediatric version, QUELIMMUNE (SCD-PED), received FDA approval on February 21, 2024 under a Humanitarian Device Exemption for pediatric acute kidney injury (AKI) due to sepsis or a septic condition requiring kidney replacement therapy, and first shipped commercially in July 2024. The company is also running the NEUTRALIZE-AKI pivotal trial in adult AKI patients requiring continuous renal replacement therapy (CRRT) and a feasibility study in adult cardiorenal syndrome awaiting LVAD implantation.

Revenue drivers

• QUELIMMUNE (SCD-PED) pediatric AKI sales — The only commercial product; net revenue was $0.6M in Q2 2026, up 82% year over year, with a customer base of 20 children's hospitals and gross margin of 91%.
• Adult AKI SCD therapy (pre-approval) — Not yet revenue-generating; the company says the U.S. adult AKI market is 50 times larger than the current pediatric market and depends on the NEUTRALIZE-AKI trial and a modular PMA submission.
• Cardiorenal syndrome / other BDD indications — Feasibility-stage only; six FDA Breakthrough Device Designations cover adult AKI, cardiorenal syndrome awaiting LVAD, hepatorenal syndrome, end stage renal disease, and systemic inflammatory response during cardiac surgery, none of which currently produce revenue.

Recent performance

Second quarter 2026 net revenue was approximately $0.6 million, up 82% from roughly $0.3 million in the second quarter of 2025, which the company attributed to new customer orders. Cost of goods sold was $54 thousand, producing a 91% gross margin versus 92% a year earlier. Research and development expense rose to $2.5 million from $1.0 million, driven primarily by increased clinical activity. Reported quarterly revenue has risen each period from $183 thousand in Q3 2025 to $420 thousand in Q4 2025, $495 thousand in Q1 2026, and $615 thousand in Q2 2026.

Strategy

Management is focused on enrolling 339 adult AKI patients in the NEUTRALIZE-AKI pivotal trial and working with the FDA on a modular Premarket Approval application for the SCD therapy. The company obtained dedicated CMS ICD-10-PCS codes for SCD therapy in inpatient AKI patients using renal replacement therapy, effective October 1, 2026, to support standardized hospital billing. It is also expanding QUELIMMUNE use through physician education, including the KidneyBee Summit 2026 and a pediatric sepsis-associated AKI webinar. Growth in pediatric revenue is presented by management as supporting the larger adult opportunity, which the company describes as roughly 50 times the current U.S. pediatric market.

Risks

• Going concern and funding — The company's own risk factor summary cites substantial doubt about its ability to continue as a going concern and the possibility of lack of availability of additional funds.
• Single-product concentration — The risk factors state the company will initially depend on revenue generated from a single product, which is currently QUELIMMUNE.
• Adult approval uncertainty — The adult AKI opportunity depends on completing NEUTRALIZE-AKI and obtaining FDA approval, and the risk factors note potential challenges in obtaining additional FDA approvals to market the product.
• Persistent losses and cash burn — The company has incurred losses since inception and expects to continue incurring significant losses; operating cash flow was negative in every year from 2021 through 2025 ($-13.6M in 2025).

Outlook

Management says it is targeting completion of NEUTRALIZE-AKI enrollment around year-end 2026 or into the first quarter of 2027, which would enable a PMA application to the FDA near the end of 2027, pending a positive trial outcome. Enrollment stood at 223 of 339 patients as of the August 2026 update. The new ICD-10-PCS codes for SCD therapy are expected to take effect October 1, 2026. No specific revenue or earnings guidance was provided.