This section highlights FDA-related milestones and regulatory updates for drugs developed by SeaStar Medical (ICU).
Over the past two years, SeaStar Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
NEUTRALIZE-AKI, NEUTRALIZE-CRS, and QUELIMMUNE. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
NEUTRALIZE-AKI FDA Regulatory Timeline and Events
NEUTRALIZE-AKI is a drug developed by SeaStar Medical for the following indication: In adults with acute kidney injury.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NEUTRALIZE-AKI
- Announced Date:
- May 13, 2025
- Estimated Event Date Range:
- July 1, 2025 - September 30, 2025
- Target Action Date:
- Q3 2025
- Indication:
- In adults with acute kidney injury
Announcement
SeaStar Medical anticipates the DSMB will report its findings to the company in the third quarter of 2025.
AI Summary
SeaStar Medical Holding Corporation announced that it has reached the halfway point in its NEUTRALIZE-AKI trial, which is testing the SCD therapy for patients with acute kidney injury who require continuous renal replacement therapy. The study has now enrolled 100 patients, and the first half of the trial data will undergo a blinded interim analysis by an independent Data Safety Monitoring Board (DSMB).
Importantly, SeaStar Medical anticipates that the DSMB will report its findings to the company in the third quarter of 2025. This report is expected to assess the safety profile and initial efficacy signals of the therapy, which are critical for deciding whether to proceed with the full trial. The upcoming DSMB report will provide key insights that could shape the future development of this potentially transformative treatment for critically ill patients.
Read Announcement- Drug:
- NEUTRALIZE-AKI
- Announced Date:
- May 13, 2025
- Indication:
- In adults with acute kidney injury
Announcement
SeaStar Medical Holding Corporation announces hat it has successfully reached the halfway point in the NEUTRALIZE-AKI pivotal clinical trial, enabling a per protocol prespecified interim analysis by the trial's independent Data Safety Monitoring Review Board (DSMB).
AI Summary
SeaStar Medical Holding Corporation announced it has reached the halfway point in its NEUTRALIZE-AKI pivotal clinical trial. This achievement means that 100 of the planned 200 patients have been enrolled, and the trial now meets the criteria for a prespecified interim analysis. An independent Data Safety Monitoring Review Board (DSMB) will review the trial's primary endpoint results from these patients. The interim analysis is designed to assess safety and confirm the study’s power to detect the expected treatment effects in patients with Acute Kidney Injury (AKI) who require continuous renal replacement therapy (CRRT).
SeaStar Medical expects that the DSMB will complete and report its findings in the third quarter of 2025. This milestone is an important step in ensuring that the trial meets the required safety and efficacy standards before moving forward to complete enrollment and further analysis.
Read Announcement- Drug:
- NEUTRALIZE-AKI
- Announced Date:
- October 8, 2024
- Indication:
- In adults with acute kidney injury
Announcement
SeaStar Medical Holding announces the activation of Brooke Army Medical Center (BAMC) and the United States Army Institute of Surgical Research (USAISR), expanding the number of sites in its NEUTRALIZE-AKI pivotal trial.
AI Summary
SeaStar Medical Holding has expanded its NEUTRALIZE-AKI pivotal trial by activating two new clinical sites: Brooke Army Medical Center (BAMC) and the United States Army Institute of Surgical Research (USAISR). These military facilities join the existing network, bringing the total number of active sites to 11, with 48 subjects already enrolled in the study. The NEUTRALIZE-AKI trial is designed to test the safety and efficacy of SeaStar’s innovative Selective Cytopheretic Device (SCD) in treating acute kidney injury (AKI) in adult ICU patients who require continuous kidney replacement therapy.
The inclusion of BAMC and USAISR is expected to enhance patient recruitment and provide a broader range of insights into the treatment’s performance. By expanding the trial network, SeaStar Medical moves closer to making this potentially life-changing therapy available to critically ill patients in diverse hospital settings.
Read Announcement- Drug:
- NEUTRALIZE-AKI
- Announced Date:
- September 25, 2024
- Indication:
- In adults with acute kidney injury
Announcement
SeaStar Medical Holding announces the enrollment of four additional subjects in a 10-day period in its pivotal NEUTRALIZE-AKI trial, bringing total trial enrollment to 46.
AI Summary
SeaStar Medical Holding has announced a promising update from its NEUTRALIZE-AKI trial. In just a 10-day period, the company enrolled four additional patients, increasing the total enrollment to 46 subjects. The trial focuses on assessing the safety and effectiveness of the company’s innovative Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) who are in the intensive care unit and undergoing continuous kidney replacement therapy. This enrollment surge follows a slower summer period affected by lower ICU census numbers. SeaStar Medical views this progress as a step toward faster trial completion and eventual commercialization of a potentially practice-changing therapy. Upcoming plans include a key interim analysis midway through the trial, which could lead to early study conclusions if the results show statistical significance, as the study works toward ultimately enrolling 200 subjects.
Read Announcement
NEUTRALIZE-CRS FDA Regulatory Events
NEUTRALIZE-CRS is a drug developed by SeaStar Medical for the following indication: SCD Therapy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NEUTRALIZE-CRS
- Announced Date:
- May 28, 2025
- Indication:
- SCD Therapy
Announcement
SeaStar Medical Holding Corporation announced that that the U.S. Centers for Medicare & Medicaid Services (CMS) has agreed to pay for certain expenses incurred by medical centers treating patients covered by Medicare or Medicaid who are enrolled in the NEUTRALIZE-CRS investigational clinical trial.
AI Summary
SeaStar Medical Holding Corporation announced that the Centers for Medicare & Medicaid Services (CMS) has agreed to cover certain medical expenses for Medicare and Medicaid patients participating in the NEUTRALIZE-CRS investigational clinical trial. This rare CMS reimbursement, granted to fewer than 100 clinical trials each year, highlights the potential life-saving benefits of SeaStar’s innovative Selective Cytopheretic Device (SCD) therapy. The trial aims to assess how the SCD therapy can counteract destructive hyperinflammation by neutralizing overactive immune cells, which can lead to severe complications in patients with acute heart failure and worsening renal function.
This decision emphasizes CMS’s confidence in the trial’s ability to improve patient outcomes and reduce healthcare costs. It also underscores the critical role of CMS reimbursement in supporting access to novel therapies for critically ill patients under Medicare and Medicaid.
Read Announcement
QUELIMMUNE FDA Regulatory Timeline and Events
QUELIMMUNE is a drug developed by SeaStar Medical for the following indication: For the treatment of children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or septic condition requiring kidney replacement therapy (KRT).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- QUELIMMUNE
- Announced Date:
- July 22, 2025
- Indication:
- For the treatment of children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or septic condition requiring kidney replacement therapy (KRT).
Announcement
SeaStar Medical Holding announced positive preliminary results from the SAVE Surveillance Registry which is assessing the use of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury (AKI) and sepsis requiring Renal Replacement Therapy (RRT).
AI Summary
SeaStar Medical announced positive preliminary results from its SAVE Surveillance Registry, evaluating QUELIMMUNE therapy in critically ill pediatric patients with life-threatening acute kidney injury (AKI) and sepsis requiring renal replacement therapy (RRT).
Among the first 20 children treated, there were no device-related safety issues, and 75% survived through 28 days. These early findings suggest QUELIMMUNE may reduce mortality by at least half compared to historical outcomes, even in patients treated as a last resort.
Additional analyses—covering 60-day and 90-day survival rates and dialysis dependence—are expected to be submitted as an abstract to a leading pediatric nephrology conference this fall.
The SAVE Registry will continue gathering real-world evidence on up to 300 pediatric patients, capturing 90-day survival, dialysis needs and safety, with planned comparisons to a matched control group to confirm QUELIMMUNE’s potential benefits and support broader clinical adoption.
Read Announcement- Drug:
- QUELIMMUNE
- Announced Date:
- July 23, 2024
- Indication:
- For the treatment of children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or septic condition requiring kidney replacement therapy (KRT).
Announcement
SeaStar Medical Holding Corporation announced that the Company has now met the August 20, 2024 FDA deadline to begin patient treatments, which is designated in the FDA's approval of QUELIMMUNE.
AI Summary
SeaStar Medical Holding Corporation announced that it has met the FDA’s requirement to begin patient treatments by the August 20, 2024 deadline. This milestone, part of the FDA’s approval of their device QUELIMMUNE, marks a critical step for the company in bringing its innovative treatment to pediatric patients with acute kidney injury (AKI). QUELIMMUNE is designed to treat children weighing 10 kilograms or more who are facing severe conditions from sepsis and need kidney replacement therapy. The company’s achievement means that its research and development efforts, along with its clinical trials, have met the rigorous standards set by the FDA. SeaStar Medical sees this as a promising advancement in improving patient care by potentially reducing dialysis dependency and improving survival rates among critically ill children.
Read Announcement- Drug:
- QUELIMMUNE
- Announced Date:
- July 23, 2024
- Indication:
- For the treatment of children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or septic condition requiring kidney replacement therapy (KRT).
Announcement
SeaStar Medical Holding reports treatment of the first patient in a commercial setting with QUELIMMUNE™, its U.S. Food and Drug Administration (FDA)-approved, patented cell-directed extracorporeal therapy to treat acute kidney injury (AKI) in pediatric patients weighing 10 kilograms or greater with sepsis or a septic condition requiring kidney replacement therapy (KRT).
AI Summary
SeaStar Medical Holding treated its first pediatric patient in a commercial setting using QUELIMMUNE™, its FDA-approved and patented cell-directed extracorporeal therapy. This treatment is designed for children weighing at least 10 kilograms who suffer from acute kidney injury (AKI) due to sepsis or a septic condition and require kidney replacement therapy. By treating this first patient, SeaStar Medical has met the FDA deadline of August 20, 2024, to begin patient treatments for this device. Clinical trials have shown promising results, with improved survival rates and a reduction in long-term dialysis dependency in severely ill children. The technology works by targeting overactive proinflammatory cells, helping to restore a balance in the body’s immune response. SeaStar Medical is dedicated to expanding access to this therapy, which could significantly improve outcomes for pediatric patients suffering from AKI.
Read Announcement- Drug:
- QUELIMMUNE
- Announced Date:
- July 3, 2024
- Indication:
- For the treatment of children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or septic condition requiring kidney replacement therapy (KRT).
Announcement
SeaStar Medical Holding announces that the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has agreed to the final labeling for SeaStar Medical's QUELIMMUNE™, the Selective Cytopheretic Device for pediatric patients, paving the way under the Humanitarian Use Device (HUD) designation to market the therapeutic device in the U.S. for the treatment of children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or septic condition requiring kidney replacement therapy (KRT).
AI Summary
SeaStar Medical Holding has announced that the FDA’s Center for Biologics Evaluation and Research (CBER) has agreed to the final labeling for its QUELIMMUNE™ device. This Selective Cytopheretic Device is developed to help treat pediatric patients weighing 10 kilograms or more who suffer from acute kidney injury (AKI) and sepsis or septic conditions requiring kidney replacement therapy (KRT).
The final labeling marks an important milestone under the Humanitarian Use Device (HUD) designation, allowing SeaStar Medical to move forward with marketing the device in the U.S. The approval supports the company’s goal to offer a critical treatment option to children in intensive care with limited alternatives. With the labeling finalized, the company is preparing to ship the QUELIMMUNE™ kits, aiming to improve survival rates and quality of life for these vulnerable patients.
Read Announcement
