SeaStar Medical Holding Corporation develops and commercializes extracorporeal medical-device therapies for critically ill patients with organ failure driven by hyperinflammation. Its first commercial product, QUELIMMUNE (SCD-PED), is based on the company’s Selective Cytopheretic Device technology and is FDA approved for pediatric acute kidney injury associated with sepsis or a septic condition in patients requiring renal replacement therapy.
Recurring company updates cover QUELIMMUNE adoption by children’s hospitals, SAVE post-approval registry data, publications and conference presentations, and financial results. News also addresses clinical development of SCD therapy in adult acute kidney injury requiring continuous renal replacement therapy and in cardio-renal indications, as well as FDA Breakthrough Device and Humanitarian Device pathways for additional SCD uses.
SeaStar Medical (ICU) announced that Chief Medical Officer Kevin Chung, MD, has been named the 2026 Combat Nephrology Award recipient.
The award recognizes contributions to kidney support in trauma, combat casualty and other high-acuity settings, linking military medicine with civilian critical care. Chung will accept the award at the Update in Critical Care Nephrology meeting in Madrid, Spain, held October 14–15, 2026. He is also the conference keynote speaker, presenting AKI in Military Operations: From Battlefield Experience to Future Strategies on October 15 at 8:00 a.m. GMT.
SeaStar Medical (Nasdaq: ICU) received FDA Breakthrough Device Designation for SCD therapy targeting hyperinflammation in adults with sepsis or a septic condition. The Selective Cytopheretic Device, or SCD, now has seven Breakthrough Device Designations across different indications. The designation provides a pathway that can accelerate development, assessment and review for FDA approval; it is not an approval.
The ongoing NEUTRALIZE-AKI pivotal clinical trial includes a pre-specified statistical analysis of patients with sepsis or a septic-like condition. SeaStar expects data for this indication in the near term and plans to submit relevant data to the FDA as quickly as possible. Earlier designations cover inflammatory conditions involving acute kidney injury, adult and pediatric cardiac surgery, heart failure with worsening kidney function, chronic dialysis and hepatorenal syndrome.
SeaStar Medical (Nasdaq: ICU) entered warrant-exercise agreements on October 2, 2026, expected to generate approximately $3.3 million in gross proceeds. The agreements cover immediate exercise of outstanding warrants for up to 854,002 common shares at a reduced price of $3.866 per share, versus original exercise prices of $6.38 to $7.62.
In exchange for cash exercise, SeaStar Medical will issue new warrants to purchase up to 1,708,004 common shares at $3.616 per share. These warrants are immediately exercisable and divided into two equal tranches with different expiration periods. Closing is expected on or about October 5, 2026, subject to customary closing conditions. Gross proceeds exclude placement agent fees and other offering expenses.
SeaStar Medical (ICU) announced acceptance of a late-breaking abstract for presentation at ASN Kidney Week on October 22, 2026.
The abstract evaluates post-approval SAVE Registry data, comparing the pediatric Selective Cytopheretic Device surveillance registry with a historical cohort in pediatric sepsis-associated acute kidney injury. Poster TH-PO1291 will be presented from 10:00 a.m. to 12:00 p.m. MT in Exhibit Hall A at the Colorado Convention Center in Denver. The meeting runs October 21–25, 2026.
SeaStar Medical (ICU) announced new hospital procedure codes for its SCD therapy, effective October 1, 2026, for acute kidney injury.
The three ICD-10-PCS codes, used to report inpatient procedures, cover patients requiring renal replacement therapy, which replaces kidney filtration. They distinguish intermittent, prolonged intermittent and continuous urinary filtration using selective cytopheresis. Hospitals can use them for billing, documentation and statistical reporting. SeaStar Medical expects simpler coding to broaden access to QUELIMMUNE for children and support adoption of SCD therapy for adults with acute kidney injury, if approved.
SeaStar Medical (ICU) Chief Medical Officer Kevin Chung will present at the PPETS conference in Houston on October 6, 2026.
His talk will use QUELIMMUNE to discuss the development of a therapy for critically ill children with acute kidney injury. James Odum will give a separate presentation on SeaStar Medical’s Selective Cytopheretic Device therapy during the same session.
SeaStar Medical (ICU) announced that SCD inventor H. David Humes will receive the University of Michigan's 2026 Distinguished University Innovator award. He is scheduled to receive it at Celebrate Invention on September 24, 2026, in Ann Arbor, Michigan.
SeaStar Medical developed his Selective Cytopheretic Device (SCD) as QUELIMMUNE, an FDA-approved therapy specifically for children with acute kidney injury (AKI) and sepsis or a sepsis-like condition. The company has launched QUELIMMUNE in pediatric critical care. SeaStar Medical reports a 50% reduction in patient mortality at 60 days compared with standard care in clinical trials and published preliminary outcomes analyses to date. Its pivotal NEUTRALIZE-AKI trial is testing SCD therapy in adults with life-threatening AKI receiving continuous renal replacement therapy.
SeaStar Medical (ICU) will present at the HC Wainwright 28th Annual Global Investment Conference in New York City from September 14–16, 2026.
The company’s presentation by CEO Eric Schlorff will be available online starting September 11, 2026, at 7:00 a.m. Eastern Time via the Events & Presentations page in the Investor Relations section of SeaStar Medical’s website, and will remain accessible for 60 days following the event.
SeaStar Medical (Nasdaq: ICU) reported second quarter 2026 net revenue of $0.6 million, up 82% from $0.3 million a year earlier, driven by QUELIMMUNE product sales to an expanded base of 20 pediatric hospitals. Gross margin was approximately 91%.
Research and development expenses rose to $2.5 million and general and administrative expenses to $1.8 million, leading to a net loss of $3.7 million, or $0.91 per share, versus a $2.0 million loss in 2025. Cash was $7.0 million at June 30, 2026, down from $12.0 million at year-end 2025.
The NEUTRALIZE-AKI pivotal trial in adult AKI has enrolled 223 of 339 patients, with enrollment completion anticipated around late 2026 or early 2027. SeaStar Medical also obtained dedicated ICD-10-PCS codes for its SCD therapy effective October 1, 2026, supporting hospital billing for inpatient AKI treatment.
SeaStar Medical (Nasdaq: ICU) will report its second quarter 2026 financial results after market close on Wednesday, August 12, 2026. Management will host a webcast and conference call at 4:30 p.m. ET / 2:30 p.m. MT to discuss financial results and business progress.
Investors can access a live webcast and replay online. Preregistration is required to join the live call; a PIN code and dial-in number are provided upon registration. A replay will be available starting at 7:30 p.m. ET on the same day.