Continued adoption of the QUELIMMUNE(R) therapy yielded 247% increase in net revenue compared to the third quarter of 2025
Achieved nearly 75% enrollment in the NEUTRALIZE-AKI pivotal clinical trial in adult patients with acute kidney injury (AKI) receiving CRRT
Reported statistically significant higher survival for QUELIMMUNE-treated patients versus comparator cohort at ASN Kidney Week 2026 late-breaking presentation
Fulfilled FDA post-approval requirements for SAVE Registry study
Webcast today at 4:30 p.m. Eastern Time
DENVER, Nov. 11, 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 September 30, 2026, and provided business updates on key initiatives.
"The strength of the QUELIMMUNE therapy adoption in this ultra-rare pediatric AKI market provides great promise for our pipeline indications, " said Eric Schlorff, CEO of SeaStar Medical. "And we continue to build momentum in educating the critical care pediatric health care community. In addition to several medical meeting presentations by Dr. Kevin Chung, our CMO, we have already begun sharing with critical care professionals the statistically significant higher survival in QUELIMMUNE-treated patients that was presented at the late-breaking presentation at ASN Kidney Week 2026."
Mr. Schlorff continued, "The NEUTRALIZE-AKI pivotal clinical trial has enrolled nearly 75% of its intended 339 patients, and we have already submitted the first module of the premarket approval application to the FDA in hopes that our modular submission will speed this potential approval. Our Breakthrough Device Designation for this indication will also enable a priority review once we submit the final module with the NEUTRALIZE-AKI pivotal trial results, provided a positive outcome in the trial."
Key Business Highlights
Since the beginning of the third quarter, SeaStar Medical's key business updates include the following:
-- Expanded the use of the QUELIMMUNE (SCD-PED) therapy as a treatment for
ultra-rare sepsis-associated AKI in pediatric patients receiving renal
replacement therapy (RRT), increasing net revenue 247% to $635 thousand
compared to the third quarter of 2025. Gross profit margins remained at
greater than 90%.
-- Presented at ASN Kidney Week 2026 real-world pediatric patient survival
data from the commercial use of the QUELIMMUNE therapy based on results
from the SAVE Registry of 50 critically ill pediatric patients with
life-threatening sepsis-associated AKI. The QUELIMMUNE (SCD-PED) therapy
group showed statistically significant higher survival in the primary
analysis at Day 60, Day 90, and at hospital discharge versus comparator
cohorts. No device-related adverse events occurred in patients treated
with the QUELIMMUNE (SCD-PED) therapy.
-- Fulfilled FDA post-approval requirements for the SAVE Registry study for
QUELIMMUNE for the treatment of sepsis-associated AKI in pediatric
patients. FDA's decision now enables hospitals to employ the QUELIMMUNE
therapy without the research infrastructure that the SAVE Registry
demanded, which may increase availability for these critically ill
pediatric patients.
-- Advanced enrollment in the NEUTRALIZE-AKI pivotal clinical trial
evaluating the SCD therapy as a potential treatment for adult patients
with AKI in the ICU receiving continuous renal replacement therapy
(CRRT). The trial is nearly 75% enrolled, with 251 of 339 patients
enrolled to date. The NEUTRALIZE-AKI pivotal clinical trial is expected
to complete enrollment by mid-year 2027.
-- Completed and submitted to the FDA the first module of a modular
premarket approval $(PMA)$ application for the potential approval of the
SCD therapy as a treatment for adult patients with AKI in the ICU
receiving CRRT.
-- Granted Breakthrough Device Designation from the FDA for the SCD therapy
for the treatment of hyperinflammation in adult patients with sepsis or a
septic condition. The Breakthrough Device Designation is a regulatory
pathway designed to provide for accelerated development, assessment, and
review for FDA approval of medical devices and potentially more effective
treatments of life-threatening or irreversibly debilitating diseases or
conditions. This marks the seventh Breakthrough Device Designation for
the SCD therapy thus far across a range of indications.
-- Received dedicated International Classification of Diseases, 10th
Revision, Procedure Coding System (ICD-10-PCS codes) from the Centers for
Medicare & Medicaid Services (CMS). These codes, which took effect on
October 1, 2026, enable administrative, billing, and statistical
reporting for the use of SeaStar Medical's SCD therapy in patients with
AKI requiring RRT in the inpatient hospital setting.
Financial Results for the Third Quarter 2026
Net revenue for the three months ended September 30, 2026, and 2025, was approximately $0.6 million and $0.2 million, respectively, reflecting increased sales of QUELIMMUNE.
Cost of goods sold for the three months ended September 30, 2026, and 2025, was $48 thousand and $14 thousand respectively.
Research and development expenses for the three months ended September 30, 2026, and 2025, were $3.6 million and $1.9 million, respectively. The increase in research and development expenses was primarily driven by increased clinical research activities for the NEUTRALIZE-AKI pivotal clinical trial, SCD development costs, personnel, and payroll costs.
General and administrative expenses for the three months ended September 30, 2026, and 2025, were approximately $1.6 million and $1.9 million, respectively. The decrease in general and administrative expenses was the result of a decline in personnel, legal, audit, and SEC-related costs, partially offset by increased professional services, director fees, and franchise taxes.
Other income (net) for the three months ended September 30, 2026, was approximately $0.1 million compared to other expense of approximately $0.1 million for the three months ended September 30, 2025.
Net loss for the three months ended September 30, 2026, was approximately $4.5 million, or $1.03 per share on approximately 4.4 million weighted-average shares outstanding. This compares with a net loss of approximately $3.5 million, or $1.30 per share, on approximately 2.7 million weighted-average shares outstanding for the three months ended September 30, 2025.
Cash at September 30, 2026, was $4.0 million, which does not include the $3.3 million of gross proceeds from warrant exercises that occurred in October 2026. This compares to cash of $12.0 million at December 31, 2025.
SeaStar Medical Third Quarter Financial Results Conference Call
Date/Time: Wednesday, November 11, 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 a septic condition weighing 10 kilograms or more and aged <=22 years 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.
The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device $(SCD)$ therapy and could have broad applications for treating the destructive hyperinflammation that shuts down organ function and causes loss of life.
QUELIMMUNE was approved by FDA under a Humanitarian Device Exemption based on safety and probable benefit. The effectiveness of this device for this use has not been demonstrated. Adverse reactions observed in clinical studies include hypotension, hypothermia, tachycardia, hyperglycemia, and thrombocytopenia. Additional risks may include blood loss or extracorporeal circuit complications. QUELIMMUNE must be used with citrate anticoagulation.
For complete risk information, please see: https://seastarmedical.com/quelimmune
About the SeaStar Medical Selective Cytopheretic Device (SCD) Therapy