FDA Grants SeaStar Medical Breakthrough Device Designation for its SCD Therapy for the Treatment of Hyperinflammation in Adult Patients with Sepsis or a Septic Condition
Globe Newswire•07/10/2026•08:16 ET
2
Key Highlights
- ➤FDA grants SeaStar Medical (ICU) Breakthrough Device Designation for SCD sepsis therapy
- ➤Designation marks SCD therapy’s seventh Breakthrough Device indication
- ➤NEUTRALIZE-AKI trial includes pre-specified sepsis subgroup analysis for FDA data submission
- ➤SCD therapy targets hyperinflammation in adult sepsis, which affects 1.7 million U.S. adults annually
- ➤SeaStar Medical’s pediatric QUELIMMUNE therapy holds FDA Humanitarian Device Exemption approval
Expert Statements
Eric Schlorff, CEO of SeaStar Medical
“This new Breakthrough Device Designation for our SCD therapy continues to exemplify the importance and critical need for an innovative therapy that can effectively treat the hyperinflammation that destroys organs and takes far too many lives each year.”
Eric Schlorff, CEO of SeaStar Medical
“Our protocol for the ongoing NEUTRALIZE-AKI pivotal clinical trial includes pre-specified statistical analysis of the subset of patients with sepsis or septic like condition, and as such, we expect to have important data to present to the FDA for this indication in the near term.”
Eric Schlorff, CEO of SeaStar Medical
“We will move as quickly as possible to submit the relevant data to the FDA and discuss ways to help these patients who today have few options for effectively treating sepsis.”
Kevin Chung, MD, Chief Medical Officer of SeaStar Medical
“Sepsis remains one of the most challenging conditions we face in critical care, in large part because treating the infection does not necessarily stop the dysregulated immune response that drives organ injury.”
Kevin Chung, MD, Chief Medical Officer of SeaStar Medical
“The SCD therapy is designed to selectively modulate that response without broadly suppressing the immune system.”
Kevin Chung, MD, Chief Medical Officer of SeaStar Medical
“This Breakthrough Device Designation underscores the significant unmet need in the treatment of sepsis, and we look forward to working with the FDA to advance this therapy for critically ill patients.”
Kevin Chung, MD, Chief Medical Officer of SeaStar Medical
“This is now the seventh indication for which the SCD has received Breakthrough Device Designation.”
Kevin Chung, MD, Chief Medical Officer of SeaStar Medical
“Each reflects the FDA’s determination that the applicable criteria have been met, including a reasonable expectation that the technology could provide more effective treatment for a life-threatening or irreversibly debilitating condition.”
Kevin Chung, MD, Chief Medical Officer of SeaStar Medical
“We believe the breadth of these designations reinforces the disease-agnostic potential of the SCD platform to address dysregulated inflammation across multiple serious conditions, and we are committed to generating the clinical evidence needed to advance these indications.”
Potentially accelerates development, assessment, and review for approval by FDA
Sepsis impacts about 1.7 million U.S. adults annually and contributes to nearly one in three in-hospital deaths
Get started
Create a free account to read the full story.