SeaStar Medical Holding Corporation (NASDAQ: ICU) reported second quarter 2026 net revenue of $0.6 million, reflecting an 82% increase year-over-year from $0.3 million in the same period of 2025. The growth was driven by increased demand for its QUELIMMUNE therapy, which treats ultra-rare pediatric acute kidney injury (AKI). The company added three new top-rated children’s hospitals to its customer base, bringing the total to 20 customers.

Despite the revenue growth, SeaStar Medical posted a net loss of $3.7 million ($0.91 per share) for the quarter, compared to a net loss of $2.0 million ($1.77 per share) in Q2 2025. The widening loss was primarily due to higher operating expenses associated with clinical trials and corporate overhead.

Financial Performance

Gross profit remained robust at $0.56 million, with gross margins holding steady at 91% for Q2 2026, slightly down from 92% in the prior year period. Cost of goods sold increased proportionally with revenue, rising from $27 thousand to $54 thousand.

Operating expenses surged significantly during the quarter:

• Research and development: Rose to $2.5 million from $1.0 million in Q2 2025, driven by increased clinical trial expenses and personnel costs related to the NEUTRALIZE-AKI pivotal trial.
• General and administrative: Increased to $1.8 million from $1.0 million, attributed to higher compensation costs, legal fees, and SEC-related expenses.

Other income improved to a net gain of $0.1 million, reversing a net expense of $0.2 million in the prior year quarter, largely due to reduced financing fees and higher interest income.

What the Numbers Show

The divergence between revenue growth and operating expense expansion highlights the company’s dual focus on commercializing its pediatric product while heavily investing in adult market validation. While QUELIMMUNE revenue grew 82%, total operating expenses more than doubled to $4.35 million. This indicates that current commercial revenues are not yet sufficient to offset the capital intensity required for the NEUTRALIZE-AKI pivotal trial and associated administrative scaling.

Balance Sheet and Cash Position

As of June 30, 2026, SeaStar Medical held $7.0 million in cash, a decline from $12.0 million at December 31, 2025. Total assets decreased to $8.6 million from $14.2 million over the same period. Current liabilities rose to $4.4 million from $3.7 million, primarily due to an increase in accrued expenses from $2.3 million to $3.5 million. Accounts receivable remained stable at $0.2 million.

Business Updates

The company advanced its pipeline toward adult AKI treatment:

• Clinical Trial Progress: The NEUTRALIZE-AKI pivotal trial has enrolled 223 of its target 339 patients. Completion is anticipated by year-end or early Q1 2027, potentially enabling a Premarket Approval (PMA) application to the FDA by late 2027.
• Reimbursement Codes: The Centers for Medicare & Medicaid Services (CMS) issued dedicated ICD-10-PCS codes for SeaStar’s selective cytopheretic device (SCD) therapy, effective October 1, 2026. These codes enable standardized billing for inpatient hospital use.
• Market Expansion: CEO Eric Schlorff noted that the adult AKI market is approximately 50 times larger than the current pediatric market, positioning the SCD therapy for significant scale upon FDA approval.

SeaStar Medical Holding Corporation is advancing treatment options for pediatric patients with acute kidney injury (AKI) through sponsorship of key educational initiatives. The company is supporting the KidneyBee Summit 2026 at Children’s Hospital Colorado from July 14 to 16, 2026, and hosting a webinar on August 11, 2026, to discuss its QUELIMMUNE therapy. AKI is a major driver of critical illness and high mortality rates, with significant gaps in awareness and clinical protocol persisting in pediatric medicine.

Kevin Chung, MD, Chief Medical Officer of SeaStar Medical, emphasized the company's commitment to improving outcomes for critically ill children. "The current reality is that more than 50% of these children lose their life to this complication of their acute illness," Chung stated. "We are committed to helping give these patients a chance."

The KidneyBee Summit 2026 is a specialized interdisciplinary conference bringing together nurses, advanced practice providers, and physicians to address systemic failures in pediatric kidney failure recognition. SeaStar Medical is also sponsoring an educational webinar titled "Rethinking Pediatric Sepsis-Associated AKI: What Clinicians Should Know About QUELIMMUNE," scheduled for August 11, 2026, from 12:00 to 1:00 pm Eastern Time. The webinar will feature speakers from leading pediatric hospitals, including Cincinnati Children’s Hospital Medical Center and C.S. Mott Children’s Hospital.

QUELIMMUNE (SCD-PED) therapy is a first-in-class disease-modifying device designed to neutralize over-active immune cells and stop cytokine storms, which cause destructive hyperinflammation. Approved in February 2024 under a Humanitarian Device Exemption application, the therapy is commercialized for children with AKI and sepsis weighing 10 kilograms or more who are on antibiotics and receiving renal replacement therapy (RRT) in the ICU.

Clinical data from two trials published in Kidney Medicine showed a 77% survival rate for patients treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in mortality. No dialysis was required for survivors, and 87.5% had normal kidney function at Day 60 after ICU discharge. Real-world data from the SAVE Registry, published in Pediatric Nephrology, reported a 76% survival rate at Day 28 and Day 60, and 71% at Day 90, with no device-related adverse events or infections.

In January 2025, SeaStar Medical received the 2025 Corporate Innovator Award from the National Kidney Foundation for its contributions to pediatric AKI treatment. The company's Selective Cytopheretic Device (SCD) therapy has broad applications for treating destructive hyperinflammation, which can lead to multi-organ dysfunction and failure. SeaStar Medical is currently conducting the NEUTRALIZE-AKI pivotal clinical trial for adult patients with AKI requiring continuous RRT, a condition affecting over 200,000 adults annually in the U.S.