Added 3 top-rated children's hospitals to QUELIMMUNE$(R)$ pediatric acute kidney injury (AKI) customer base, increasing net revenue 82% versus second quarter 2025
Advanced enrollment in the NEUTRALIZE-AKI pivotal clinical trial in adult patients with AKI
Obtained ICD-10-PCS codes to enable standardized inpatient hospital billing for its selective cytopheretic device $(SCD)$ therapy, including QUELIMMUNE
Webcast today at 4:30 pm Eastern Time
DENVER, Aug. 12, 2026 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life, announced today financial results for the three months ended June 30, 2026, and provided business updates on key initiatives.
"The enthusiasm for the use of our QUELIMMUNE therapy is resonating broadly throughout the pediatric critical care community," said Eric Schlorff, CEO of SeaStar Medical. "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."
Mr. Schlorff continued, "We are keenly focused on achieving our enrollment target of 339 adult AKI patients in the NEUTRALIZE-AKI trial, and we are working with the FDA on our modular Premarket Approval $(PMA)$ application for our SCD therapy as an organ-sparing and life-saving treatment for the adult patient population. With strong gross margins for QUELIMMUNE and universal ICD-10-PCS codes already established for our SCD therapies, we believe this first-in-class therapy for the treatment of adult patients with AKI has clear potential to both save lives and create significant shareholder value, should we obtain FDA approval."
Key Business Highlights
SeaStar Medical's achievements since the beginning of the second quarter of 2026 include the following:
-- Expanded the use of QUELIMMUNE (SCD-PED) therapy for ultra-rare pediatric
AKI, adding 3 new customers from top-rated children's hospitals, bringing
the total customer base to 20 and building increased depth in customer
orders. This led to second quarter 2026 net revenue of $0.6 million for
QUELIMMUNE product sales, an increase of 82% versus the second quarter of
2025.
-- Advanced enrollment in the NEUTRALIZE-AKI pivotal clinical trial
evaluating the SCD therapy as a potential treatment of adult patients
with AKI in the ICU receiving continuous renal replacement therapy. The
trial has enrolled 223 of 339 patients to date. Completion of enrollment
is anticipated around year end or into the first quarter of 2027, which
would enable a PMA application to the FDA near the end of 2027, pending a
positive outcome of the trial.
-- Received from the Centers for Medicare & Medicaid Services $(CMS)$
dedicated International Classification of Diseases, 10th Revision,
Procedure Coding System (ICD-10-PCS) codes. These codes enable
administrative, billing, and statistical reporting for the use of SeaStar
Medical's SCD therapy in patients with AKI requiring renal replacement
therapy in the inpatient hospital setting. The new ICD-10-PCS codes are
expected to take effect on October 1, 2026.
-- Sponsored and participated in the KidneyBee Summit 2026. The Summit,
which occurs annually, is a highly specialized, interdisciplinary
conference that brings together nurses, advanced practice providers, and
physicians from across the country. Its core importance stems from
tackling the exact systemic failures that leave pediatric kidney failure
under-recognized.
-- Assembled leading experts in the treatment of pediatric AKI to speak at
the SeaStar Medical educational webinar, "Rethinking Pediatric
Sepsis-Associated AKI," that brought together practicing pediatric
nephrologists, critical care physicians, advanced practice providers,
nurses, and critical care teams to learn more about pediatric
sepsis-associated AKI and the use of the QUELIMMUNE therapy.
Financial Results for the Second Quarter 2026
Net revenue for the three months ended June 30, 2026, was approximately $0.6 million reflecting increased demand for the QUELIMMUNE therapy. This compared to net revenue of approximately $0.3 million for the three months ended June 30, 2025.
Cost of goods sold for the three months ended June 30, 2026, and 2025, was $54 thousand and $27 thousand reflecting gross margins of 91% and 92% for the three months ended June 30, 2026, and 2025, respectively.
Research and development expenses for the three months ended June 30, 2026, and 2025, were $2.5 million and $1.0 million, respectively. The increase in research and development expenses was primarily driven by increased clinical trial expenses and personnel costs.
General and administrative expenses for the three months ended June 30, 2026, and 2025, were approximately $1.8 million and $1.0 million, respectively. The increase in general and administrative expenses was the result of an increase in compensation costs, legal and professional fees, and certain Securities and Exchange Commission (SEC) related expenses.
Other income (net) was $0.1 million for the three months ended June 30, 2026, compared to other expense (net) of $0.2 million for the three months ended June 30, 2025. The change was primarily related to a reduction in financing fees and increased interest income.
Net loss for the three months ended June 30, 2026, was approximately $3.7 million, or $0.91 per share on approximately 4.1 million weighted-average shares outstanding. This compares with a net loss of approximately $2.0 million, or $1.77 per share, on approximately 1.1 million weighted-average shares outstanding for the three months ended June 30, 2025.
Cash at June 30, 2026, was $7.0 million, compared to $12.0 million at December 31, 2025.
SeaStar Medical Second Quarter Financial Results Conference
Call
Date/Time: Wednesday, August 12, 2026, at 4:30 p.m. ET / 2:30
p.m. MT
Webcast: The live webcast and replay can be found here.
Register for the call: Preregistration is required to attend the live call
and can be accessed here. A pin code and dial in
number will be provided with registration.
A replay of the call will be available after 7:30
p.m. ET and can be accessed here.
About QUELIMMUNE
The QUELIMMUNE(R) (SCD-PED) therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with RRT. It was approved in February 2024 under a Humanitarian Device Exemption application.
Data from two clinical trials of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors, and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge. In February 2026, data published in the prestigious, peer-reviewed journal, Pediatric Nephrology, highlighted the early experience from the QUELIMMUNE SAVE Registry, a post-approval surveillance registry, evaluating the role of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury (AKI) and sepsis requiring renal replacement therapy. Observations from the first 21 pediatric patients with AKI and sepsis requiring renal replacement therapy showed no device-related adverse events or infections and no reports of immunosuppressive effects by the device. In addition, preliminary outcomes analyses show a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90. These new data are on track to validate a 50% reduction in patient mortality at 60 days compared to historical data, similar to what was observed in the registration study reported in Kidney Medicine.
The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device (SCD) therapy and has broad applications for treating the destructive hyperinflammation that shuts down organ function and causes loss of life.
About the SeaStar Medical Selective Cytopheretic Device (SCD) Therapy
The SCD therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient's body. The SCD therapy is designed for broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing continuous RRT hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future continuous RRT, including dialysis, and prevent loss of life.
About NEUTRALIZE-AKI Pivotal Trial
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