SeaStar Medical (NASDAQ:ICU) reported higher first-quarter revenue from its QUELIMMUNE therapy and said it remains focused on expanding pediatric hospital adoption while advancing a pivotal trial for its adult acute kidney injury, or AKI, program.
On a conference call covering first-quarter 2026 results, Chief Executive Officer Eric Schlorff said the company is “making good progress” toward its 2026 goals while maintaining “a disciplined use” of financial resources. He said QUELIMMUNE net revenue rose nearly 70% from the first quarter of 2025, supported by seven new hospital customers adopting the therapy during the quarter.
QUELIMMUNE Adoption Expands in Pediatric AKI
Tim Varacek, senior vice president of commercial and business operations, said QUELIMMUNE net revenue totaled $495,000 in the first quarter of 2026, up 69% from $293,000 in the prior-year quarter. He said the company is seeing an increase in orders from many customers and described the pediatric AKI market as “small but important” because it validates SeaStar’s selective cytopheretic device, or SCD, technology and may support future opportunities in adult indications.
Varacek said SeaStar ended the quarter with 17 customers, compared with three or four customers at the same time last year. He said some hospitals have established inventory “par values” based on utilization, while newer customers are still determining patient cadence and ordering patterns.
Asked during the Q&A session whether hospitals are placing repeat orders, Varacek said the company “absolutely” sees repeat orders across its customer base. However, he said reorder timing is unpredictable because it depends on when appropriate pediatric AKI patients present at a hospital.
Varacek also highlighted SeaStar’s education efforts, including a symposium at the AKI & CRRT meeting in San Diego and an advanced provider advisory board. He said the company is working with hospital staff involved in protocols, orders and training to support implementation of QUELIMMUNE.
Adult AKI Trial Enrollment Reaches 198 Patients
Chief Medical Officer Dr. Kevin Chung said the company continues to enroll patients in NEUTRALIZE-AKI, its randomized controlled pivotal trial evaluating SCD therapy in critically ill adult patients with AKI requiring continuous renal replacement therapy. The trial is designed to assess whether up to 10 sequential 24-hour SCD treatments can improve 90-day survival or renal recovery.
The primary endpoint is a composite of mortality or dialysis dependence at 90 days. Chung said SeaStar has enrolled 198 patients out of a target of 339 and is targeting completion of enrollment around year-end 2026, which could position the company to report top-line results in mid-2027.
Schlorff said SeaStar is adding clinical sites to expand enrollment, citing UCLA as one of the latest hospitals to join the trial. He also said the company continues to work with the U.S. Food and Drug Administration on several fronts, including discussions about a modular premarket approval, or PMA, submission for adult AKI and potential rapid approval pathways for SCD therapy.
Chung said the modular PMA approach would allow SeaStar to submit portions of the application before pivotal clinical data are available, with the trial data submitted as the final element. He said that structure is intended to let the FDA begin reviewing nonclinical modules earlier and “often speeds the overall review” of applications.
SAVE Registry and Clinical Awareness
Chung said SeaStar completed enrollment of 50 patients in the SAVE Registry, which tracks commercial use of QUELIMMUNE in critically ill children. The company is completing the 28-day safety analysis for the final enrolled patients and expects to submit top-line safety data to the FDA shortly.
Along with that submission, Chung said SeaStar plans to request that the registry shift from mandatory status to a voluntary post-marketing study. If approved, he said the change would reduce administrative burdens on children’s hospitals and could accelerate adoption and access.
Chung also said QUELIMMUNE has gained visibility within the pediatric nephrology and critical care communities. He pointed to discussion of the therapy at the AKI & CRRT meeting and two articles in the American Society of Nephrology’s Kidney News that addressed SCD therapy, its mechanism, clinical evidence and potential.
During the Q&A session, Chung said the company holds monthly virtual clinical user calls with current and prospective pediatric nephrology and critical care teams. He said the calls review recent QUELIMMUNE cases, including patient condition, treatment rationale and outcomes.
Asked about integrating SCD into intensive care workflows, Chung said the SCD cartridge is connected in series to an existing CRRT circuit and can be added by CRRT technicians, dialysis technicians or ICU nurses in minutes. He said citrate anticoagulation is a critical component of the therapy and noted that many centers already have experience with citrate protocols.
Financial Results and Cash Position
Chief Financial Officer Mike Messinger said SeaStar recorded first-quarter 2026 gross profit margin of more than 90%, consistent with the prior three quarters. He noted that the company did not recognize cost of goods sold in the first quarter of 2025 because QUELIMMUNE units sold at that time had been expensed to research and development before approval and commercialization, in accordance with U.S. GAAP.
Operating expenses were approximately $4.1 million in the first quarter of 2026, unchanged from the first quarter of 2025. Messinger said SeaStar expects research and development expenses to increase modestly, around 5% each quarter, as it supports more clinical sites and enrollment, while general and administrative spending is expected to remain relatively consistent quarter to quarter for the rest of 2026.
SeaStar reported a first-quarter net loss of approximately $3.5 million, or $0.90 per share, based on about 3.9 million weighted average shares outstanding. That compared with a net loss of approximately $3.8 million, or $4.38 per share, based on about 862,000 weighted average shares outstanding in the first quarter of 2025.
The company ended March 31, 2026, with more than $9.3 million in cash, compared with $5.2 million at March 31, 2025.
Schlorff said SeaStar remains focused on key value drivers for patients, the medical community and investors. He said relationships developed through the adult AKI pivotal trial may support a potential launch of SCD therapy in the adult indication if clinical and regulatory milestones are achieved.
About SeaStar Medical (NASDAQ:ICU)
SeaStar Medical, Inc (NASDAQ: ICU) is a medical device company focused on the development and commercialization of cerebral embolic protection systems for patients undergoing transcatheter aortic valve replacement (TAVR) procedures. The company’s mission is to reduce the risk of stroke and other neurologic events associated with structural heart interventions by capturing or deflecting embolic debris that can travel to the brain during catheter-based therapies.
The company’s flagship product, TriGUARD® 3, is a next-generation embolic deflection device designed to provide coverage of all three cerebral vessels during TAVR.
