SeaStar Medical Holding (ICU) Company Report

SeaStar Medical CEO Eric Schlorff will present at Noble Capital Markets’ Emerging Growth Virtual Equity Conference on Thursday, February 5th at 11:30 am Eastern Time.
A replay of the presentation will be available starting Monday, February 9th after 11:30 am Eastern Time and will remain accessible for up to 30 days.
The company's QUELIMMUNE (SCD-PED) therapy was FDA approved in 2024 for acute kidney injury (AKI) due to sepsis or a septic condition in critically ill pediatric patients.
SeaStar Medical's Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA and is currently undergoing the NEUTRALIZE-AKI pivotal trial for adult AKI patients.

Jan 29, 2026, 1:25 PM

SeaStar Medical (ICU) Provides Business Update and 2026 Milestones

ICU

Product Launch

New Projects/Investments

Guidance Update

SeaStar Medical (ICU) reported a gross profit of approximately 90% and a strong balance sheet with over $13 million in cash and zero long-term debt as of September 30, 2025. The company anticipates finishing 2025 with about $1 million in sales for its Quellimune product.
For its pediatric Quellimune product, ICU ended 2025 with 10 active customers and aims to reach 20-25 customers by the end of 2026. The FDA recently agreed to reduce the required patient count for the post-market surveillance registry from 300 to 50.
The pivotal Neutralize-AKI study for adults with acute kidney injury is 40-50% complete as of early December 2025, with full enrollment targeted by the end of 2026.

Jan 13, 2026, 11:00 PM

SeaStar Medical (ICU) Provides Business Update

ICU

Guidance Update

New Projects/Investments

Revenue Acceleration/Inflection

SeaStar Medical's commercial product, QUELIMMUNE, for pediatric acute kidney injury (AKI) was launched in Q3 2024, targeting a $100 million market in the U.S..
The company reported over $13 million in cash and $11 million-plus in shareholders' equity as of September 30, 2025, with zero long-term debt, and projects approximately $1 million in QUELIMMUNE sales for 2025.
The pivotal NEUTRALIZE-AKI study for adult AKI, a 339-patient study, was 40%-50% complete as of early December (2025), with full enrollment expected by the end of 2026.
Key milestones for 2026 include doubling the QUELIMMUNE customer base and advancing the cardiorenal syndrome (CRS) study.
SeaStar Medical holds six Breakthrough Device designations from the FDA for its platform, covering multiple indications beyond pediatric AKI.

Jan 13, 2026, 11:00 PM

SeaStar Medical Reports Q3 2025 Financial Results and Clinical Trial Updates

ICU

Earnings

Guidance Update

New Projects/Investments

SeaStar Medical reported net revenue of $183,000 from Quellimune sales for Q3 2025, achieving a gross profit margin of 92%. The company projects full-year 2025 revenue will exceed $1 million.
Operating expenses decreased to $3.7 million in Q3 2025, resulting in a net loss of $3.5 million (or $0.13 per share). Cash on hand as of September 30, 2025, was $13.8 million.
The NEUTRALIZE-AKI pivotal trial's interim analysis confirmed the SCD therapy to be safe. Enrollment has reached 146 patients, with the target increased to 339 patients and completion anticipated by the end of 2026.
The company launched the NEUTRALIZE-CRS clinical trial for cardiorenal syndrome, which will enroll 20 patients and is expected to complete enrollment within approximately one year.

Nov 13, 2025, 9:30 PM

SeaStar Medical Reports Q3 2025 Financial Results and Business Updates

ICU

Earnings

Product Launch

New Projects/Investments

SeaStar Medical reported net revenue of $0.2 million and a net loss of $3.5 million, or $0.13 per share, for the third quarter ended September 30, 2025.
The company strengthened its balance sheet by raising $12.4 million through equity offerings and warrant exercises in Q3 2025, resulting in $13.8 million in cash as of September 30, 2025.
Business highlights include the adoption of QUELIMMUNE therapy by three new top-rated children's hospitals and positive survival results from its commercial use, showing 76% of pediatric patients surviving through 60 days.
An interim analysis of the NEUTRALIZE-AKI pivotal clinical trial for adults indicated a positive signal toward efficacy and zero device-related safety issues, leading to an adjusted enrollment target of approximately 339 patients, with 146 patients enrolled as of Q3 2025. Enrollment is anticipated to be completed by the end of 2026.

Nov 13, 2025, 9:12 PM

SeaStar Medical's NEUTRALIZE-AKI Trial Recommended for Continuation with Increased Enrollment

ICU

New Projects/Investments

Guidance Update

The independent Data Safety Monitoring Review Board (DSMB) has recommended the continuation of SeaStar Medical Holding Corp.'s NEUTRALIZE-AKI pivotal trial for its Selective Cytopheretic Device (SCD) therapy in adult patients with acute kidney injury (AKI).
An interim analysis of the first 100 patients revealed zero device-related safety issues and indicated a signal of potential clinical benefit in the treatment group.
To enhance statistical power, the DSMB advised increasing the total patient enrollment from 200 to 339 patients.
Patient enrollment for the trial is now estimated to be complete near the end of 2026.