SeaStar Medical reports 'positive' results for QUELIMMUNE therapy in AKI
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jul 22 2025
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Should l Buy ICU?
Positive Preliminary Results: SeaStar Medical reported promising initial findings from the SAVE Surveillance Registry, indicating that 75% of critically ill pediatric patients treated with QUELIMMUNE therapy for Acute Kidney Injury and sepsis survived through 28 days without any device-related safety events.
Future Data Submission: Additional analyses and survival results will be submitted later this summer as an abstract to a pediatric nephrology conference, supporting the approval of QUELIMMUNE under a Humanitarian Device Exemption.
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About ICU
SeaStar Medical Holding Corporation is a commercial-stage medical technology company, which is focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. The Company’s Selective Cytopheretic Device (SCD) 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. It has broad potential applications for patients suffering from both acute and chronic kidney disease as well as cardiovascular and other serious inflammatory diseases. Its SCD therapy is an extracorporeal synthetic membrane device designed to bind activated leukocytes (neutrophils and monocytes) when integrated into an existing continuous renal replacement therapy (CRRT) circuit in conjunction with the use of regional citrate anticoagulation (RCA).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
SeaStar Medical Presents New Therapy Data at AKI Conference
- Therapy Efficacy Validation: SeaStar Medical's QUELIMMUNE SAVE Registry data presented at the AKI & CRRT 2026 conference indicates no device-related adverse events among the first 21 pediatric patients treated with the Selective Cytopheretic Device (SCD), achieving a 76% survival rate at Day 28 and Day 60, and 71% at Day 90, demonstrating an approximate 50% reduction in mortality compared to historical data, validating the therapy's effectiveness.
- Immunomodulatory Mechanism: Research shows that SCD therapy modulates the immune response by shifting pro-inflammatory monocytes to an anti-inflammatory reparative phenotype, potentially counteracting the hyperinflammation that drives organ failure in AKI, thereby enhancing the clinical applicability of the therapy.
- Educational Symposium Held: SeaStar Medical hosted an educational symposium featuring leading pediatric nephrology experts during the conference, introducing the first Advanced Practice Provider Panel to support broader adoption of QUELIMMUNE, reflecting the company's commitment to promoting the new therapy's accessibility.
- Adult Trial Advancement: The company is advancing its NEUTRALIZE-AKI pivotal trial targeting AKI in adults, a condition affecting over 200,000 adults annually in the U.S. with no effective treatment options, highlighting SeaStar Medical's strategic significance in addressing a critical market need.
See More
SeaStar Medical Presents SAVE Registry Data on Pediatric AKI Treatment
- SAVE Registry Data Released: SeaStar Medical presented new SAVE Registry data at the International Conference on Advances in Critical Care Nephrology, revealing no device-related adverse events in pediatric patients treated with SCD, with survival rates of 69% at both Day 28 and Day 60, indicating the therapy's effectiveness and safety in clinical settings.
- Immunomodulation Research Advances: In vitro analysis demonstrates that the Selective Cytopheretic Device (SCD) can shift monocytes towards an anti-inflammatory and reparative phenotype, further validating the device's potential in modulating immune responses and offering new solutions for treating hyper-inflammatory states.
- Successful Industry Symposium: The symposium hosted by SeaStar Medical attracted leading experts in pediatric Acute Kidney Injury (AKI) to discuss the role of SCD technology in modulating immune cells, enhancing the company's leadership position in the field and promoting broader adoption of QUELIMMUNE therapy.
- Future Development Outlook: SeaStar Medical's QUELIMMUNE therapy received FDA approval in 2024 for critically ill pediatric patients with AKI and sepsis, expected to significantly reduce patient mortality rates and further solidify the company's market position in pediatric nephrology treatment.
See More
SeaStar Medical Reports Improved Q4 Results with Revenue Growth
- Performance Improvement: SeaStar Medical's Q4 net loss narrowed to $2.90 million, or $0.80 per share, from $4.41 million and $8.98 per share last year, indicating a significant improvement in financial health.
- Revenue Growth: The company reported net revenue of $420,000 in Q4, a substantial increase from $67,000 a year ago, primarily driven by sales of QUELIMMUNE, reflecting rising market acceptance.
- Clinical Trial Progress: The NEUTRALIZE-AKI pivotal trial has enrolled 181 adult AKI patients out of a target of 339, achieving over 50% enrollment, which is expected to facilitate the application of SCD therapy in the adult market.
- Future Outlook: SeaStar Medical plans to expand QUELIMMUNE adoption to 15 top-ranked children's medical centers by 2026, anticipating approximately $2 million in net product revenue, demonstrating confidence in future growth.
See More
SeaStar Medical Reports Key 2025 Financial Highlights
- Revenue Growth: SeaStar Medical reported over $1.1 million in QUELIMMUNE sales for 2025, with gross profit margins exceeding 90%, although the pediatric AKI market is limited to about $100 million, indicating niche market potential.
- Customer Base Expansion: The company added 13 new customers in 2025, bringing the total to 16, reflecting initial success in promoting QUELIMMUNE therapy in top-rated children's hospitals, despite challenges in expanding hospital adoption.
- Financial Improvement: SeaStar Medical added approximately $24 million in capital while reducing operating liabilities by $3.1 million in 2025, demonstrating positive financial management, even as it reported a net loss of $12.2 million.
- Clinical Trial Progress: In the pivotal trial for neutralized AKI, 181 out of 339 patients have been enrolled, although completion is targeted for the end of 2026, potentially delaying revenue from adult AKI treatments.
See More
SeaStar Medical Q4 Earnings Beat Expectations
- Earnings Performance: SeaStar Medical reported a Q4 GAAP EPS of -$0.80, beating market expectations by $0.21, indicating an improving trend in financial performance despite still being in a loss position.
- Significant Revenue Growth: The company achieved revenue of $0.4 million in Q4, representing a substantial year-over-year increase of 566.7%, exceeding expectations by $0.03 million, suggesting strong product demand that could drive future market share growth.
- Positive Market Reaction: The earnings report's outperformance may positively impact SeaStar Medical's stock price, enhancing investor confidence in the company's future growth potential and potentially attracting more investor interest.
- Improving Financial Health: Although still in a loss position, the significant revenue growth and better-than-expected EPS indicate SeaStar Medical's efforts to improve financial health, potentially laying the groundwork for future financing and expansion.
See More
SEASTAR MEDICAL ANNOUNCES FOURTH QUARTER AND FULL YEAR 2025 FINANCIAL RESULTS ALONG WITH BUSINESS UPDATES
Financial Results: SEA STAR MEDICAL reported its financial results for the fourth quarter and the full year of 2025, highlighting key performance metrics and financial health.
Business Updates: The report includes significant business updates, outlining strategic initiatives and developments that may impact future operations and growth.
See More
SeaStar Medical Presents New Therapy Data at AKI Conference
- Therapy Efficacy Validation: SeaStar Medical's QUELIMMUNE SAVE Registry data presented at the AKI & CRRT 2026 conference indicates no device-related adverse events among the first 21 pediatric patients treated with the Selective Cytopheretic Device (SCD), achieving a 76% survival rate at Day 28 and Day 60, and 71% at Day 90, demonstrating an approximate 50% reduction in mortality compared to historical data, validating the therapy's effectiveness.
- Immunomodulatory Mechanism: Research shows that SCD therapy modulates the immune response by shifting pro-inflammatory monocytes to an anti-inflammatory reparative phenotype, potentially counteracting the hyperinflammation that drives organ failure in AKI, thereby enhancing the clinical applicability of the therapy.
- Educational Symposium Held: SeaStar Medical hosted an educational symposium featuring leading pediatric nephrology experts during the conference, introducing the first Advanced Practice Provider Panel to support broader adoption of QUELIMMUNE, reflecting the company's commitment to promoting the new therapy's accessibility.
- Adult Trial Advancement: The company is advancing its NEUTRALIZE-AKI pivotal trial targeting AKI in adults, a condition affecting over 200,000 adults annually in the U.S. with no effective treatment options, highlighting SeaStar Medical's strategic significance in addressing a critical market need.
See More
SeaStar Medical Presents SAVE Registry Data on Pediatric AKI Treatment
- SAVE Registry Data Released: SeaStar Medical presented new SAVE Registry data at the International Conference on Advances in Critical Care Nephrology, revealing no device-related adverse events in pediatric patients treated with SCD, with survival rates of 69% at both Day 28 and Day 60, indicating the therapy's effectiveness and safety in clinical settings.
- Immunomodulation Research Advances: In vitro analysis demonstrates that the Selective Cytopheretic Device (SCD) can shift monocytes towards an anti-inflammatory and reparative phenotype, further validating the device's potential in modulating immune responses and offering new solutions for treating hyper-inflammatory states.
- Successful Industry Symposium: The symposium hosted by SeaStar Medical attracted leading experts in pediatric Acute Kidney Injury (AKI) to discuss the role of SCD technology in modulating immune cells, enhancing the company's leadership position in the field and promoting broader adoption of QUELIMMUNE therapy.
- Future Development Outlook: SeaStar Medical's QUELIMMUNE therapy received FDA approval in 2024 for critically ill pediatric patients with AKI and sepsis, expected to significantly reduce patient mortality rates and further solidify the company's market position in pediatric nephrology treatment.
See More
SeaStar Medical Reports Improved Q4 Results with Revenue Growth
- Performance Improvement: SeaStar Medical's Q4 net loss narrowed to $2.90 million, or $0.80 per share, from $4.41 million and $8.98 per share last year, indicating a significant improvement in financial health.
- Revenue Growth: The company reported net revenue of $420,000 in Q4, a substantial increase from $67,000 a year ago, primarily driven by sales of QUELIMMUNE, reflecting rising market acceptance.
- Clinical Trial Progress: The NEUTRALIZE-AKI pivotal trial has enrolled 181 adult AKI patients out of a target of 339, achieving over 50% enrollment, which is expected to facilitate the application of SCD therapy in the adult market.
- Future Outlook: SeaStar Medical plans to expand QUELIMMUNE adoption to 15 top-ranked children's medical centers by 2026, anticipating approximately $2 million in net product revenue, demonstrating confidence in future growth.
See More
SeaStar Medical Reports Key 2025 Financial Highlights
- Revenue Growth: SeaStar Medical reported over $1.1 million in QUELIMMUNE sales for 2025, with gross profit margins exceeding 90%, although the pediatric AKI market is limited to about $100 million, indicating niche market potential.
- Customer Base Expansion: The company added 13 new customers in 2025, bringing the total to 16, reflecting initial success in promoting QUELIMMUNE therapy in top-rated children's hospitals, despite challenges in expanding hospital adoption.
- Financial Improvement: SeaStar Medical added approximately $24 million in capital while reducing operating liabilities by $3.1 million in 2025, demonstrating positive financial management, even as it reported a net loss of $12.2 million.
- Clinical Trial Progress: In the pivotal trial for neutralized AKI, 181 out of 339 patients have been enrolled, although completion is targeted for the end of 2026, potentially delaying revenue from adult AKI treatments.
See More
SeaStar Medical Q4 Earnings Beat Expectations
- Earnings Performance: SeaStar Medical reported a Q4 GAAP EPS of -$0.80, beating market expectations by $0.21, indicating an improving trend in financial performance despite still being in a loss position.
- Significant Revenue Growth: The company achieved revenue of $0.4 million in Q4, representing a substantial year-over-year increase of 566.7%, exceeding expectations by $0.03 million, suggesting strong product demand that could drive future market share growth.
- Positive Market Reaction: The earnings report's outperformance may positively impact SeaStar Medical's stock price, enhancing investor confidence in the company's future growth potential and potentially attracting more investor interest.
- Improving Financial Health: Although still in a loss position, the significant revenue growth and better-than-expected EPS indicate SeaStar Medical's efforts to improve financial health, potentially laying the groundwork for future financing and expansion.
See More
SEASTAR MEDICAL ANNOUNCES FOURTH QUARTER AND FULL YEAR 2025 FINANCIAL RESULTS ALONG WITH BUSINESS UPDATES
Financial Results: SEA STAR MEDICAL reported its financial results for the fourth quarter and the full year of 2025, highlighting key performance metrics and financial health.
Business Updates: The report includes significant business updates, outlining strategic initiatives and developments that may impact future operations and growth.
See More
