SeaStar Medical Holding Corp Stock Price, News & Analysis

SeaStar Medical announces FDA Breakthrough Device Designation for its Selective Cytopheretic Device (SCD) to treat chronic systemic inflammation in end-stage renal disease patients requiring chronic hemodialysis. This marks the fourth Breakthrough designation for SCD, expanding the company's addressable U.S. patient population to 745,000 annually. The device targets over 480,000 U.S. individuals requiring in-center hemodialysis, with treatment costs around $100,000 per patient yearly. The SCD is designed to selectively target proinflammatory neutrophils and monocytes during continuous renal replacement therapy, potentially improving survival and quality of life for patients who currently face a 42% five-year survival rate.

SeaStar Medical (Nasdaq: ICU) reports record monthly enrollment of 10 patients in its NEUTRALIZE-AKI pivotal trial, bringing total enrollment to 56. The trial evaluates the company's Selective Cytopheretic Device (SCD) in adults with acute kidney injury receiving continuous renal replacement therapy. With 12 clinical sites now activated, including new teaching hospitals and military facilities, enrollment is expected to accelerate. The trial aims to enroll up to 200 adults, with an interim analysis planned at 100 subjects. The SCD has FDA Breakthrough Device Designation, and the trial received Category B coverage from Medicare & Medicaid for certain expenses.

SeaStar Medical (Nasdaq: ICU) has shipped QUELIMMUNE to its second hospital customer, marking its first sale since transitioning to a direct sales model. QUELIMMUNE, an FDA-approved Selective Cytopheretic Device (SCD) for treating critically ill children with acute kidney injury and sepsis, now generates 100% revenue recognition for the company. Recent data presented at ASN Kidney Week showed potential cost savings of approximately $30,000 per hospitalization using QUELIMMUNE, compared to standard care costs of $460,000. The company aims to make QUELIMMUNE available in 4-5 leading pediatric hospitals by end of 2024.

SeaStar Medical presented new economic data for its QUELIMMUNE device at ASN Kidney Week 2024, demonstrating significant cost-saving potential in treating pediatric acute kidney injury (AKI). Analysis shows hospitalization costs of $461,736 for pediatric AKI patients requiring CRRT, with QUELIMMUNE projected to save approximately $30,000 per hospitalization. The device achieves cost neutrality after 6 days of therapy and shows a 77% survival rate in children ≥10 kg and ≤22 years, compared to 50% standard care survival rate. The company presented four posters at the conference, including studies on the ongoing NEUTRALIZE-AKI pivotal trial and upcoming NEUTRALIZE-CRS trial.

SeaStar Medical presented economic analysis data for its QUELIMMUNE device at ASN Kidney Week 2024, demonstrating significant cost-saving potential in treating pediatric acute kidney injury (AKI). The analysis revealed that hospitalization costs for pediatric AKI patients requiring CRRT averaged $461,736, while treatment with QUELIMMUNE could save approximately $30,000 per hospitalization. The device achieves cost neutrality after 6 days of therapy and shows a 77% survival rate in children ≥10 kg, compared to 50% with standard care. The company also presented data on ongoing trials including NEUTRALIZE-AKI and NEUTRALIZE-CRS, highlighting their expanding therapeutic applications.

SeaStar Medical announces Stanford Medicine's clearance to enroll subjects in the NEUTRALIZE-AKI pivotal trial for their Selective Cytopheretic Device (SCD). The trial now has 12 active sites with 52 enrolled subjects, including two recently added Department of Defense medical centers. The study will evaluate SCD's safety and efficacy in adults with acute kidney injury (AKI) in ICU receiving continuous kidney replacement therapy (CKRT), aiming to enroll up to 200 adults. The primary endpoint focuses on 90-day mortality or dialysis dependency. The SCD previously received FDA Breakthrough Device Designation, and in July 2024, CMS granted Category B coverage for certain expenses in the trial.

SeaStar Medical Holding (Nasdaq: ICU) announces it has taken full responsibility for direct sales, marketing, and distribution of QUELIMMUNE™, its FDA-approved therapeutic device for treating pediatric acute kidney injury (AKI) due to sepsis. The company's CEO, Eric Schlorff, emphasizes their focus on a successful commercial rollout and their ability to fulfill customer demand. SeaStar Medical is streamlining relationships with Institutional Review Boards at pediatric hospitals and providing clinical training to integrate QUELIMMUNE into existing hemofiltration systems.

The company reports exceeding expectations with initial demand and multiple reorders from their first customer, Cincinnati Children's. By assuming direct distribution, SeaStar Medical will now recognize 100% of revenue generated from QUELIMMUNE sales in the U.S., corresponding to 3-4 times more revenue per unit. QUELIMMUNE, operating under the Humanitarian Device Exemption, has shown promising clinical results, including a 77% reduction in mortality rate and no dialysis dependency at Day 60 in pediatric AKI patients requiring continuous kidney replacement therapy.

SeaStar Medical Holding (Nasdaq: ICU) announces that its NEUTRALIZE-AKI pivotal trial has enrolled 51 subjects, surpassing the halfway point towards the 100-subject target for an interim analysis. The trial evaluates the safety and efficacy of SeaStar's Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) in ICU receiving continuous kidney replacement therapy (CKRT).

Key points:

• Enrollment pace has accelerated since summer, with 5 subjects enrolled in October
• SCD received FDA Breakthrough Device Designation for adults with AKI
• Centers for Medicare & Medicaid Services granted Category B coverage for certain expenses in July 2024
• SeaStar began shipping SCD Pediatric (QUELIMMUNE™) in July 2024
• The company extinguished all interest-bearing debt in September 2024

The NEUTRALIZE-AKI trial aims to enroll up to 200 adults at up to 30 clinical sites, with a primary endpoint of 90-day mortality or dialysis dependency.

SeaStar Medical Holding (Nasdaq: ICU) announces the presentation of new analyses of clinical data supporting the immunomodulating effect of the Selective Cytopheretic Device (SCD) at the American Society of Nephrology (ASN) 2024 Kidney Week. The data shows how the SCD significantly lowered biomarkers related to inflammation in critically ill patients with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT).

A poster presentation will highlight how SCD treatment significantly reduced the Neutrophil: Lymphocyte Ratio (NLR), a powerful biomarker linked to poor outcomes across various diseases. This provides further mechanistic clinical evidence of leukocyte immunomodulation in hyperinflammatory conditions such as AKI and sepsis.

The Company's pediatric SCD, QUELIMMUNE™, was approved by the FDA as a Humanitarian Use Device in February 2024. SeaStar Medical continues to enroll patients in its adult NEUTRALIZE-AKI pivotal trial and advance other indications like cardiorenal syndrome.