SeaStar Medical Expands QUELIMMUNE Usage Among Pediatric Care

SeaStar Medical Expands QUELIMMUNE Usage Among Pediatric Care

SeaStar Medical Holding Corporation (NASDAQ: ICU), a commercial-stage healthcare company, continues to make strides in enhancing the healthcare landscape for children battling acute kidney injury (AKI). The company's innovative QUELIMMUNE therapy, recently approved under a Humanitarian Device Exemption (HDE), is now being adopted by a renowned children’s hospital in Texas, further demonstrating the efficacy of this groundbreaking treatment for pediatric patients with life-threatening conditions.

QUELIMMUNE Therapy Approval and Impact

QUELIMMUNE therapy was sanctioned by the U.S. Food and Drug Administration to cater to pediatric patients who not only suffer from severe AKI but also require renal replacement therapy (RRT). This condition is often exacerbated by sepsis, making timely and effective treatment essential. With the integration of QUELIMMUNE into their treatment protocols, these leading pediatric medical centers are poised to improve outcomes for their young patients significantly.

As part of this advancement, the SAVE Surveillance Registry has been instituted, capturing critical safety and performance data related to QUELIMMUNE when compared against standard care practices. Preliminary findings from the registry will contribute valuable insights for future presentations at medical conferences, emphasizing SeaStar Medical’s commitment to quality care in pediatrics.

CEO's Insight on Progress

Eric Schlorff, the CEO of SeaStar Medical, shared his enthusiasm regarding the expanding application of QUELIMMUNE across top children's hospitals. “We are thrilled to see our QUELIMMUNE therapy adopted and are eager to gather valuable data from the SAVE Surveillance Registry. This data will be instrumental as we monitor the efficacy of QUELIMMUNE therapy for both pediatric and adult patients,” stated Schlorff. He also highlighted the progression in patient enrollment for the NEUTRALIZE-AKI trial, which is designed to study the performance of their selective cytopheretic device (SCD) therapy in adult patients suffering from AKI.

NEUTRALIZE-AKI Trial Overview

The pivotal NEUTRALIZE-AKI trial seeks to evaluate the efficacy and safety of SCD therapy in 200 adult patients experiencing AKI while receiving continuous renal replacement therapy. An interim analysis of the trial is currently in progress, with preliminary results expected to surface soon. This trial not only underscores SeaStar Medical’s dedication to higher standards in patient care but also secures FDA Breakthrough Device Designation for various critical conditions.

Broader Implications of AKI

Acute Kidney Injury can stem from numerous medical incidents including severe infections, trauma, or medical interventions. Its aftermath often leads to severe hyperinflammation, posing significant risks to the patient’s overall health and recovery. The treatment offered by QUELIMMUNE aims to mitigate these risks by targeting and neutralizing overactive immune responses that can lead to further complications and even multi-organ failure.

The Role of QUELIMMUNE in Pediatric Care

SeaStar’s QUELIMMUNE therapy is specifically crafted for children over 10 kilograms dealing with sepsis-related conditions while receiving antibiotic treatments. This unique therapy provides much-needed relief in an ICU setting, strategically designed to expedite recovery and minimize complications associated with AKI. With its recent HDE approval, the therapy represents a beacon of hope for many critically ill children.

In clinical studies, QUELIMMUNE demonstrated a remarkable 77% survival rate, marking a significant improvement over previous interventions. Survivors also showed encouraging signs of kidney recovery within 60 days post-ICU discharge. Such data is pivotal for advancing treatment protocols and improving overall healthcare quality for pediatric patients.

Acknowledgments and Future Directions

In recognition of its innovative contributions, SeaStar Medical received the 2025 Corporate Innovator Award from the National Kidney Foundation, celebrating its relentless pursuit of improving pediatric AKI treatment outcomes. The company remains focused on further trials and longitudinal studies to broaden the understanding of QUELIMMUNE's capabilities.

Frequently Asked Questions

What is QUELIMMUNE therapy?

QUELIMMUNE therapy is a treatment approved for critically ill pediatric patients suffering from acute kidney injury due to sepsis or septic conditions.

What is the SAVE Surveillance Registry?

The SAVE Surveillance Registry gathers and analyzes data regarding the safety and effectiveness of QUELIMMUNE therapy compared to standard care practices.

How effective is QUELIMMUNE therapy?

Clinical studies report a 77% survival rate among patients treated with QUELIMMUNE, significantly reducing mortality compared to historical data.

What does the NEUTRALIZE-AKI trial evaluate?

This pivotal trial evaluates the safety and efficacy of SeaStar Medical's SCD therapy in adult AKI patients receiving continuous renal replacement therapy.

Why was SeaStar Medical recognized with the Corporate Innovator Award?

SeaStar Medical was awarded for its impactful innovations, notably the development and introduction of QUELIMMUNE therapy for pediatric acute kidney injury.

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