SeaStar Medical (NASDAQ:ICU) management highlighted expanding commercial traction for its QUELIMMUNE therapy in ultra-rare pediatric acute kidney injury (AKI), alongside ongoing progress in its pivotal adult AKI clinical program, during the company’s fourth quarter and year-end 2025 results conference call held March 25, 2026.
Commercial uptake for QUELIMMUNE expands in pediatric AKI
Chief Executive Officer Eric Schlorff said the company expanded use of QUELIMMUNE for ultra-rare pediatric AKI in 2025 and into the first quarter of 2026. SeaStar added 13 new customers during 2025, bringing the total customer base to 16 top-rated children’s hospitals, and management said it is also seeing increased depth in customer orders.
Management reiterated that pediatric AKI is an ultra-rare market, but described it as strategically important because it can validate the company’s technology and support future opportunities. Varacek said the company estimates the pediatric AKI market at about $100 million and has refined its focus to pediatric patients treated at the top 50 children’s hospitals in the U.S.
Clinical updates: NEUTRALIZE-AKI enrollment and SAVE registry progress
Chief Medical Officer Dr. Kevin Chung provided an update on the company’s NEUTRALIZE-AKI pivotal trial for the SCD therapy in adult AKI patients in the ICU receiving continuous renal replacement therapy (CRRT). Chung said the company has enrolled 181 of a target 339 patients, including 55 additional patients since the start of the fourth quarter, and onboarded four additional clinical sites during that same period.
Chung described NEUTRALIZE-AKI as a randomized controlled trial designed to evaluate whether up to 10 sequential 24-hour SCD treatments can improve 90-day survival or renal recovery in critically ill patients with AKI requiring CRRT. The primary endpoint is a composite of mortality or dialysis dependence at 90 days. Management said it is targeting completion of enrollment around year-end 2026, which could support reporting top-line results in mid-2027.
During the Q&A, Chung said he could not share “lessons learned” from the 181 enrolled patients, but noted that approximately half were randomized to treatment, as expected in a randomized controlled trial. He also said the company recently held an in-person investigators meeting to share best practices aimed at improving enrollment and site performance.
On the pediatric post-market front, Chung said SeaStar completed enrollment of 50 patients in its SAVE registry, which tracks commercial use of QUELIMMUNE in critically ill children. He said the FDA’s new enrollment requirement was reduced to 50 patients from an original request of 300 after the agency reviewed data from the first 21 patients. SeaStar is awaiting 28-day safety data from the final patients and expects to submit a top-line safety report to the FDA soon.
Chung also discussed a publication in Pediatric Nephrology reporting early post-approval experience from the first 21 SAVE registry patients. He said there were no device-related adverse events, no infections, and no evidence of immune suppression in that initial cohort, and described survival as “encouraging,” citing 76% survival at days 28 and 60 and 71% at day 90. Chung said those outcomes tracked toward an approximate 50% reduction in mortality compared to historical controls, consistent with the company’s prior registration study.
Regulatory strategy and pipeline expansion
Schlorff said SeaStar initiated a modular pre-market approval (PMA) submission process for the SCD therapy as a potential treatment for adult AKI, noting the program has already received FDA Breakthrough Device Designation. Chung added that the company is proactively preparing PMA components that do not depend on clinical outcomes, in alignment with FDA guidance, to help streamline review.
Chung contrasted the company’s pediatric approval pathway with the adult opportunity, stating that pediatric AKI was approved under a humanitarian device exemption (HDE) pathway that requires site-level institutional review board approvals prior to use and included the mandatory SAVE registry. By contrast, he said an adult AKI approval could enable commercialization without those IRB-related barriers, potentially simplifying hospital adoption.
SeaStar also discussed a newer clinical effort in acute congestive heart failure with cardiorenal syndrome for patients awaiting left ventricular assist device (LVAD) implantation. Schlorff said the study is investigator-led and funded by the National Institutes of Health. Chung said SeaStar initiated the NEUTRALIZE-CRS trial in 2025, is actively enrolling, and expects to enroll about 20 patients. He described a differentiated dosing paradigm in that trial, with intermittent treatment up to six hours daily for up to six days, rather than the continuous approach used in NEUTRALIZE-AKI.
Financial results: revenue growth, expense reductions, and cash position
Chief Financial Officer Michael Messinger reported fourth quarter 2025 net revenue from QUELIMMUNE sales of approximately $315,000, compared with $67,000 in the fourth quarter of 2024. For full-year 2025, QUELIMMUNE net revenue was $1.1 million, up from $135,000 in 2024, which Messinger attributed to the first full year of product sales and an expanding customer base.
Messinger also reported $105,000 of fourth quarter net revenue from the sale of the SCD to the AREVA Research Institute, describing it as the first of two orders related to a Department of Defense grant supporting research into extracorporeal immunomodulation for inflammation after severe burns, inhalation injury, and septicemia. He said SeaStar anticipates a second order of up to an additional $100,000, though timing is uncertain.
On profitability, Messinger said the company’s fourth quarter and full-year gross profit margin was greater than 90%. He also said operating expenses declined to $3.4 million in the fourth quarter of 2025 from $4.8 million in the prior-year quarter, and fell to $13.4 million for full-year 2025 from $18 million in 2024. Net loss for the fourth quarter of 2025 was approximately $2.9 million, or $0.80 per share, compared with a net loss of approximately $4.4 million, or $8.98 per share, in the fourth quarter of 2024. Full-year net loss was $12.2 million in 2025 versus $24.8 million in 2024.
Messinger said SeaStar improved its balance sheet through approximately $23.9 million in capital added during 2025 and a $3.1 million reduction in operating liabilities. He said the company had approximately $12 million in cash as of December 31, 2025, compared with $1.8 million at year-end 2024, and reported no long-term debt. In response to an analyst question, Messinger said he expects spending in 2026 to be more in line with 2025 and the recent quarterly run rate.
2026 milestones and outlook discussed on the call
Management outlined four key areas of focus for 2026, led by advancing the SCD therapy in adult AKI. Schlorff said the company aims to complete enrollment in NEUTRALIZE-AKI around the end of 2026, positioning the company to finalize its PMA submission next year if the trial is successful. He characterized the adult opportunity as “50 times” the size of the pediatric AKI market.
For QUELIMMUNE, Schlorff said the company plans to add 15 new top-ranked children’s medical centers in 2026 and is targeting $2 million in product revenue from QUELIMMUNE sales this year. Varacek said the company does not expect to add additional salespeople, but plans to increase clinical representation at hospitals and expand education and adoption resources, including an educational symposium at the AKI & CRRT meeting and an advanced practice provider advisory board focused on best practices for QUELIMMUNE activation.
In Q&A, Varacek said the company’s confidence in adding 15 new centers is supported by having already added six sites in the first quarter and by forecasting progress through the hospital adoption process. He added that SeaStar’s goal is to make the SAVE registry optional rather than mandatory, which he said could shorten timelines for site activation if achieved. Schlorff also said the company is confident in its supply chain for both pediatric and future adult demand, noting that Fresenius Medical is its contract manufacturer for the SCD.
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.
