SeaStar Medical Reports 82% QUELIMMUNE Revenue Growth as NEUTRALIZE-AKI Trial Advances Toward Adult AKI Indication
核心洞察
SeaStar Medical reported second-quarter 2026 net revenue of $615,000, an 82% year-over-year increase driven by expanded adoption of QUELIMMUNE (搜索) therapy for pediatric acute kidney injury (搜索).
The NEUTRALIZE-AKI pivotal trial has enrolled 223 of 339 targeted adult patients, with a primary endpoint of 90-day mortality or dialysis dependence and PMA submission targeted for late 2027.
The company doubled its hospital customer base to 20 of the 50 premier U.S. children's hospitals and completed the FDA-required 50-patient SAVE safety registry.
SeaStar Medical Holding Corporation (NASDAQ: ICU) reported second-quarter 2026 financial results on August 12, 2026, highlighted by an 82% year-over-year increase in net revenue to $615,000, driven by expanded adoption of its QUELIMMUNE (搜索) therapy in the pediatric acute kidney injury (搜索) (AKI) market. The company also detailed meaningful progress in its NEUTRALIZE-AKI pivotal trial, which is evaluating the same selective cytopheretic device (SCD) technology for critically ill adult patients with AKI requiring continuous renal replacement therapy (CRRT).
Commercial Momentum in Pediatric AKI
QUELIMMUNE (搜索), the proprietary brand name for SeaStar Medical's SCD therapy approved for pediatric patients, generated $615,000 in net revenue during the second quarter, up from approximately $338,000 in the prior-year period. Six-month net revenue reached $1.1 million, keeping the company on track toward its full-year 2026 target of $2 million. Gross profit margin remained at 91%, consistent with the prior four quarters, which management characterized as "pharmaceutical-like margins" for the device technology.
The company reported that 20 of the 50 premier children's hospitals in the U.S. have now purchased and used QUELIMMUNE (搜索) therapy, doubling its customer base since the beginning of 2026. The company's year-end goal is to reach 25 hospitals. Chief Executive Officer Eric Schlorff emphasized the broader opportunity, stating, "We believe our continued QUELIMMUNE revenue growth bodes well for our future potential opportunity in the adult AKI market that is 50 times larger than the current pediatric market in the U.S."
Regulatory and Administrative Milestones
The Centers for Medicare and Medicaid Services (CMS) assigned ICD-10-PCS codes for the SCD therapy, with implementation scheduled for October 1, 2026. Management expects this to simplify hospital billing and remove administrative barriers to therapy adoption. Additionally, the company completed the 50-patient SAVE Registry required by the FDA to evaluate QUELIMMUNE (搜索) safety in real-world pediatric settings, with a preliminary report submitted and a final report in preparation for FDA review. Results from the first 21 patients were published in the peer-reviewed journal Pediatric Nephrology.
The SCD technology holds breakthrough device designation for six therapeutic indications, and QUELIMMUNE (搜索) was approved for pediatric AKI under a Humanitarian Device Exemption (HDE). The SCD is described as a first-in-class immunomodulatory therapy that targets and neutralizes hyperactive leukocytes and monocytes—the immune cells primarily responsible for the cytokine storm that can lead to organ failure.
NEUTRALIZE-AKI Pivotal Trial Progress
The NEUTRALIZE-AKI trial is a randomized controlled trial assessing the SCD therapy in critically ill adult patients with AKI requiring CRRT. The primary endpoint is a 90-day composite of mortality or dialysis dependence. As of the call, 223 of the total anticipated 339 patients had been enrolled, with completion anticipated between the fourth quarter of 2026 and the first quarter of 2027.
Chief Medical Officer Kevin Chung noted that monthly enrollment has averaged 8 to 12 patients, which he characterized as "slower than what I would like," though site expansion is expected to increase the pace to 15 to 20 subjects per month. The company recently onboarded two additional clinical sites, with four more expected to begin screening shortly and at least eight additional sites committed to participating.
A key enrollment criterion is a C-reactive protein (搜索) (CRP) level greater than 3.5 mg/dL, used to ensure trial participants have sufficient inflammatory levels to demonstrate therapeutic effect. Chung emphasized that "enrolling the right patients takes precedence over enrolling quickly" to avoid the failures observed in previous sepsis (搜索) and acute kidney injury (搜索) trials. The trial also employs block randomization to ensure equal distribution of patients with acute respiratory distress syndrome (ARDS) and sepsis at enrollment.
Financial Position
Research and development expenses increased to $2.5 million from $1.0 million in the prior-year period, reflecting additional clinical sites and higher patient enrollment. General and administrative expenses rose to $1.8 million. Net loss for the quarter was $3.7 million, or $0.91 per share, compared to a net loss of $2.0 million in the prior-year period. Cash and cash equivalents stood at $7.0 million as of June 30, 2026, compared to $12.0 million at the end of 2025.
Clinical Adoption and Future Outlook
Chung highlighted a notable shift in clinical practice, observing that mature clinical sites are moving QUELIMMUNE (搜索) use from a last-resort rescue therapy toward earlier intervention. "Clinicians are scanning their ICU to see who may benefit from the therapy," he stated, based on positive earlier outcomes. Even among patients who had failed other therapies, Chung reported a 70% survival rate, which he described as "remarkable."
The company is pursuing a modular Premarket Approval (PMA) submission strategy with the FDA, which allows for review of technical and manufacturing modules before clinical data is finalized. The final clinical module submission remains targeted for late 2027. Management indicated that a PMA approval for adult AKI would enable commercialization with ICD-10-PCS codes already in place, significantly simplifying hospital adoption.