SeaStar Medical (NASDAQ:ICU) Chief Executive Officer Eric Schlorff outlined the company’s approach to treating destructive hyperinflammation in critically ill patients during a presentation at the Life Sciences Investor Forum moderated by Zacks Small Cap Research Senior Biotech Analyst David Bautz. Schlorff said the company is focused on conditions in which an overactive immune response can lead to organ failure or death, including acute kidney injury (AKI), cardiovascular disease, and surgical trauma.
Targeting hyperinflammation with a “therapeutic medical device”
Schlorff described the company’s Selective Cytopheretic Device (SCD) as a first-in-class, disease-modifying therapy designed to neutralize the most activated neutrophils and monocytes—immune cells he said can drive inflammatory cytokine activity and “cytokine storm.” He emphasized that SeaStar views the SCD as a therapeutic device rather than a purely mechanical process, likening its functional effect to a biologic or drug.
Schlorff also highlighted the broader potential he sees for the platform, estimating the addressable population for conditions that could be treated with the SCD at roughly 1 million patients annually. He added that the FDA has awarded Breakthrough Device designation to pipeline programs, which he said could help speed development for life-threatening conditions where alternatives are limited.
Pediatrics: QUELIMMUNE approval, registry progress, and expansion plans
Schlorff said SeaStar has an FDA-approved product, QUELIMMUNE for Children, and reviewed both pre-approval clinical results and post-market registry progress. He cited a 22-patient registration study in which he said survival improved to about 77% compared with historical outcomes that he characterized as roughly a “coin flip” for survival. He added that in the study there were no patients on long-term dialysis by Day 60.
He then discussed the company’s post-market SAVE Registry, which he said was mandated by the FDA under a Humanitarian Device Exemption (HDE). SeaStar previously announced data on the first 21 registry patients, and Schlorff said outcomes were consistent with the registration study in terms of mortality and dialysis dependency, including in very sick patients such as those with oncology histories or multiple transplants.
Schlorff said the company negotiated with the FDA to reduce the registry requirement from 300 patients to 50 and recently reached the 50-patient mark. He said the company is now waiting for a 28-day safety window and plans to submit the data to the FDA afterward. He also suggested that completing the registry could reduce onboarding time at hospitals, noting it can take around eight months to fully activate a site due to separate institutional approvals for the HDE and for the registry.
On commercialization, Schlorff said SeaStar reported about two active pediatric customers at the end of 2024 and about 10 by the end of 2025, with a goal to double the base by the end of 2026. He described the company’s target market as the top 50 of roughly 220 U.S. children’s hospitals, saying the company believes about half of eligible patients are concentrated in those top sites.
Adult AKI: NEUTRALIZE-AKI trial design and timeline
Schlorff provided an update on the company’s ongoing NEUTRALIZE-AKI trial in adults, describing it as a randomized controlled registration study with a target enrollment of 339 patients. He said the company previously reported approximately 40% enrollment as of December and expects to update investors on a future financial call.
The primary endpoint is a composite of 90-day mortality and freedom from dialysis dependency. Schlorff said historical mortality in the patient population is around 50% and characterized success as demonstrating a reduction in mortality and improvement in dialysis dependence consistent with pre-specified endpoints agreed with the FDA. He also noted pre-specified subpopulations, including sepsis (which he said may represent roughly 50% to 60% of the study) and acute respiratory distress syndrome (ARDS), along with a planned one-year mortality readout for durability.
He said the company’s goal is to complete enrollment by the end of 2026, which would place a potential top-line readout in the first half of the following year after a 90-day follow-up and subsequent data collation.
Regulatory pathway and standard-of-care comparison
Schlorff said the adult program would follow a premarket approval (PMA) pathway and noted that SeaStar is overseen by the FDA’s biologics division. He added the company intends to submit the PMA in modules—roughly four components—so that certain elements can be reviewed before the final clinical dataset is available.
In response to an audience question on current AKI treatments, Schlorff said the standard of care is continuous renal replacement therapy (CRRT), which he described as supportive rather than disease-modifying. He said outcomes for CRRT have not materially changed in 20 to 30 years and that he does not see other step-change options currently available.
Schlorff also referenced health economics work in pediatrics, saying a DRG reimbursement figure is about $400,000 and that, at QUELIMMUNE pricing over six days, hospitals can be “making between $40 thousand and $50 thousand per patient” in his example, driven by factors such as reduced ICU length of stay (he cited about three days) and reduced mortality. He added that the analysis did not include the longer-term cost impact of dialysis, which he said can run around $70,000 to $100,000 per year.
Additional indications, financing, and investor milestones
Beyond AKI, Schlorff discussed potential use in cardiorenal syndrome, particularly in bridging patients to left ventricular assist devices (LVADs) or transplant. He described a University of Michigan case study involving a 71-year-old male treated for six days (six hours per day), after which the patient was successfully bridged to an LVAD. He also said the company is conducting a pilot study called NEUTRALIZE-CRS, supported by the National Institutes of Health, which he described as non-dilutive and potentially relevant to another adult HDE pathway.
On capital strategy, Schlorff said the company has told the market it expects “a little over $1 million” in QUELIMMUNE revenue for 2025 with gross margins north of 90%, and that its goal is to double that in 2026. He also cited previously disclosed cash of just over $13.5 million as of late 2025 and a burn rate of roughly $1.0 million to $1.3 million per month, adding that the company has access to an at-the-market (ATM) facility and a $15 million equity line of credit, and is in discussions with potential business development partners.
Schlorff pointed to several milestones investors may watch over the next 12 to 24 months:
- Continued enrollment progress toward completion of the NEUTRALIZE-AKI trial
- Growth in pediatric QUELIMMUNE customers and quarter-to-quarter revenue trends
- Additional site activation and enrollment for the NIH-supported NEUTRALIZE-CRS program
- Regulatory activity related to potential HDE opportunities in additional indications
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.
