SeaStar Medical (NASDAQ:ICU) reported a 247% increase in third-quarter revenue from its pediatric kidney injury therapy QUELIMMUNE, while pushing back its expected enrollment completion for a pivotal adult trial to mid-2027.
Chief Executive Officer Eric Schlorff said on the company’s November 11 earnings call that enrollment in the adult acute kidney injury study has been moderated by restrictive eligibility criteria. SeaStar is adding clinical sites and supporting existing ones, but is using its current enrollment rate to set the updated timeline.
“We are clearly disappointed to extend the timeline for completion of enrollment,” Schlorff said, adding that the company’s priority is conducting a study that gives the therapy an opportunity for an optimized outcome.
Adult Trial and Regulatory Plans
The randomized NEUTRALIZE-AKI trial is evaluating SeaStar’s selective cytopheretic device, or SCD, therapy in critically ill adults with acute kidney injury who require continuous renal replacement therapy. Chief Medical Officer Dr. Kevin Chung said 251 of an anticipated 339 patients had been enrolled. The primary endpoint combines mortality or dialysis dependence at 90 days.
SeaStar recently added four clinical sites and is working to activate more by year-end, Chung said. The company has submitted the first module of its premarket approval application to the Food and Drug Administration and is preparing additional modules before trial results are available.
In response to an analyst’s question, Schlorff said SeaStar expects to file the final application module about nine months after enrollment is completed. Submission of the clinical results would depend on a positive trial outcome. Schlorff said the FDA generally has 180 days for review, although the timing is outside the company’s control.
SeaStar also received an FDA Breakthrough Device Designation for its SCD therapy to treat hyperinflammation in adults with sepsis or a septic condition. Chung said the adult kidney injury trial includes a prespecified analysis of patients with sepsis. If results are positive, the company plans to submit relevant data and discuss a path forward with the FDA.
QUELIMMUNE Sales and Registry Data
Third-quarter net revenue rose to approximately $635,000 from $183,000 a year earlier, driven by increased demand for QUELIMMUNE. Revenue for the first nine months more than doubled to $1.7 million, according to Tim Varacek, senior vice president of commercial and business operations.
SeaStar expects to exceed its existing $2 million QUELIMMUNE revenue guidance for 2026, Chief Financial Officer Mike Messinger said, though the company did not provide a new target.
Varacek said 20 of the company’s 50 targeted pediatric medical institutions are customers, including 10 added during 2026. In response to an analyst, he said essentially all 20 customers are using the product, with use dependent on eligible patients arriving at their hospitals.
Varacek said the FDA’s confirmation that SeaStar had met mandatory post-approval SAVE Registry requirements could make hospital adoption easier by reducing the time and resources required. He also said newly assigned ICD-10-PCS codes will allow hospitals to track and bill for procedures using the therapy.
Chung discussed SAVE Registry data presented at the ASN Kidney Week meeting. He said 90-day survival was 65% among QUELIMMUNE-treated patients, compared with 47% in a clinically aligned cohort from the Kids’ Inpatient Database. The difference was statistically significant, with a reported p-value of 0.043. The comparison was with a database cohort, rather than a randomized control group. Chung also said no device-related adverse events were reported among 50 treated patients.
Expenses and Cash
Operating expenses rose to $5.2 million in the third quarter from $3.7 million a year earlier. Messinger attributed higher research and development spending primarily to clinical activity associated with NEUTRALIZE-AKI, SCD development and personnel costs. General and administrative spending declined.
The company reported a net loss of approximately $4.5 million, or $1.03 per share, compared with a loss of $3.5 million, or $1.30 per share, a year earlier. The per-share figures reflect weighted average shares outstanding of about 4.4 million and 2.7 million, respectively.
Cash stood at approximately $4 million as of September 30, down from approximately $12 million at the end of 2025. That balance excludes $3.3 million in gross proceeds from warrant exercises in October, Messinger said.
About SeaStar Medical (NASDAQ:ICU)
SeaStar Medical Holding Corporation (NASDAQ: ICU) is a medical technology company developing therapies designed to address hyperinflammation, an excessive immune response that can contribute to organ damage in critically ill patients. The company’s platform is intended to selectively target and modulate pro-inflammatory immune cells while preserving the body’s broader immune function. Its lead product is the Selective Cytopheretic Device (SCD), an extracorporeal blood-purification device used alongside continuous kidney replacement therapy.
