By David Bautz, PhD
NASDAQ: ICU
READ THE FULL ICU RESEARCH REPORT
Business Update
On Track to Complete Enrollment in Phase 3 NEUTRALIZE-AKI Trial by End of 2026
SeaStar Medical Holding Corp. (NASDAQ: ICU) is currently conducting the NEUTRALIZE-AKI pivotal study to assess the safety and efficacy of the SCD in adults with AKI. It is a two-arm, randomized, open label, controlled, multi-center trial that will enroll up to 339 adult patients in the ICU with AKI requiring CRRT and at least one additional organ failure across 30 clinical centers. SCD therapy will be administered for up to 10 days with a primary outcome of all-cause mortality or dialysis dependency at day 90. An overview of the trial is given below.
The company has now enrolled 198 of 339 patients thus far. We estimate that patient enrollment will complete near the end of 2026. SeaStar has initiated efforts for the submission of a modular PMA, which may be expedited since the company was previously granted Breakthrough Device Designation by the FDA.
Update on QUELIMMUNE® Launch in Pediatric Patients
SeaStar has added seven children’s hospitals as customers of QUELIMMUNE for the treatment of pediatric acute kidney injury. The company’s goal for 2026 was 15 new customers, thus SeaStar is well on its way to achieve that goal. In addition to adding additional sites, the company is working to ensure pull-through by working with the patient care teams so they are focused on adopting QUELIMMUNE for appropriate patients in the pediatric ICU.
Net revenue for the first quarter of 2026 was approximately $0.5 million, which represented purchases from both new and repeat customers, and was a 69% increase from the first quarter of last year. The company affirmed its 2026 revenue guidance of $2.0 million, and we are confident that will be achieved based on the current trajectory.
In March 2026, SeaStar announced that it completed the required enrollment in the SAVE Registry. Fifty patients were successfully enrolled, and SeaStar will be reporting the 28-day safety results from the SAVE Registry to the FDA following analysis of the data. Results for the first 21 patients were reported in a manuscript published in February 2026 (Goldstein et al., 2026; see here for a full analysis of that data). Data from that analysis showed that survival on Days 28 and 60 were 76%, while on Day 90 it was 71%, both of which compare quite favorably to historical pediatric continuous kidney replacement therapy survival rates of approximately 50%. Importantly, there were no device-related adverse events or bloodstream infections.
SCD Technology Featured in American Society of Nephrology’s Kidney News
In the most recent issue of the American Society of Nephrology’s Kidney News (May 2026), there were two articles that discussed the selective cytopheretic device (SCD). The first was on the evolution of extracorporeal therapy, and featured the SCD as “One of the most exciting frontiers explored in this issue is the move from ‘washing’ the blood to actively modulating the immune system…”. The second article was devoted entirely to the SCD therapy, its mechanisms, clinical evidence, and future potential. These articles are an indication that the SCD therapy is entering mainstream clinical discussions.
Financial Update
On May 13, 2026, SeaStar announced financial results for the first quarter of 2026. The company reported net revenue of approximately $0.5 million, compared to approximately $0.3 million in the first quarter of 2025. The increase is due to increased customer adoption of QUELIMMUNE. R&D expenses for the first quarter 2026 were $2.3 million compared to $2.4 million in the first quarter of 2025. The decrease in R&D expenses was primarily due to lower clinical trial expenses, partially offset by increased compensation costs and device development costs. G&A expenses in the first quarters of both 2026 and 2025 were approximately $1.7 million. The slight increase in the current quarter of $24,000 was due to higher legal-related fees, accounting expenses, and marketing costs, offset by lower compensation costs and decreased SEC-related expenses.
SeaStar exited the first quarter of 2026 with $9.3 million in cash and cash equivalents. As of May 7, 2026, the company had approximately 4.0 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of 6.8 million.
Conclusion
The commercial launch of QUELIMMUNE in pediatric patients continues to go well, with SeaStar adding seven new customers as it aims for a goal of 15 additional pediatric centers by the end of 2026. Enrollment in the NEUTRALIZE-AKI trial is continuing on pace, and we continue to expect the trial to be fully enrolled by the end of the year. As the year progresses, we await additional updates on enrollment in the NEUTRALIZE-AKI trial as well as additional details on the potential for a clinical trial of the SCD therapy in patients with chronic heart failure with cardiorenal syndrome awaiting left ventricular assist device implantation. With no changes to our model, our valuation remains at $12 per share.
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