SeaStar Medical Holding Corporation (Nasdaq: ICU) is making strides in its NEUTRALIZE-AKI pivotal trial, aimed at evaluating the safety and efficacy of its Selective Cytopheretic Device (SCD) in treating adult patients with acute kidney injury (AKI) in the intensive care unit (ICU) who are receiving continuous renal replacement therapy (CRRT). The company recently activated its 14th and 15th clinical sites and provided an update on enrollment progress.
Enrollment Update and Interim Analysis
As of late December 2024, the NEUTRALIZE-AKI trial has enrolled 70 of the planned 200 subjects, including 24 in the fourth quarter. With the current pace of enrollment, SeaStar Medical anticipates a Data Safety Monitoring Board (DSMB) recommendation on the interim results by mid-2025. The company plans to conduct an interim analysis at the trial’s 90-day primary endpoint with the first 100 subjects. Enrollment in the trial currently stands at 76 with six subjects enrolled since the first of the year.
Kevin Chung, MD, Chief Medical Officer of SeaStar Medical, stated, "We are pleased to welcome the 14th and 15th hospital to our trial, especially as this site has been among the top CRRT programs in the country".
NEUTRALIZE-AKI Trial Design
The NEUTRALIZE-AKI trial is a randomized controlled trial designed to assess the SCD's impact on AKI patients. The primary endpoint is a composite of 90-day mortality or dialysis dependency among patients treated with SCD in addition to CRRT, compared to a control group receiving only CRRT. Secondary endpoints include mortality at 28 days, ICU-free days within the first 28 days, major adverse kidney events at Day 90, and dialysis dependency at one year. Subgroup analyses will explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.
Market Opportunity
SeaStar Medical estimates the annual U.S. total addressable market for the SCD in adult AKI to be between $4.7 billion and $6.3 billion. Eric Schlorff, SeaStar Medical CEO, noted that this represents a highly attractive return on a clinical trial estimated to cost approximately $15 million. He added, "AKI is one of several high-value indications for our SCD that we plan to pursue. As we work to increase accessibility of our therapeutic device among those afflicted with potentially life-threatening hyperinflammation, we believe that our clinical data showing reduced mortality and probable savings for the healthcare system will encourage adoption by the medical community."
Selective Cytopheretic Device (SCD)
The Selective Cytopheretic Device (SCD) is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during CRRT. This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future renal replacement treatment (RRT), including dialysis. The SCD has received FDA Breakthrough Device Designation for adults with AKI, cardiorenal syndrome, hepatorenal syndrome and chronic dialysis, indicating its potential to offer a substantial improvement over existing therapies.
Acute Kidney Injury (AKI) and Hyperinflammation
AKI is characterized by a sudden and temporary loss of kidney function, often caused by conditions such as COVID-19, sepsis, severe trauma, and surgery. AKI can cause hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death.
