SeaStar Medical Holding Corporation, a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyper-inflammation on vital organs, has officially confirmed the inauguration of its 14th site.
Set to enroll subjects for a new NEUTRALIZE-AKI pivotal trial, the stated facility will begin its journey by facilitating the evaluation of SeaStar’s proprietary therapeutic Selective Cytopheretic Device (SCD) in patients with acute kidney injury (AKI), specifically the ones who are currently in the intensive care unit (ICU) to receive continuous renal replacement therapy (CRRT).
Markedly enough, this comes shortly after SCD earned FDA’s Breakthrough Device Designation for adults with AKI. In case you weren’t aware, this particular designation is awarded to a therapy aimed at treating serious or life-threatening condition with preliminary clinical evidence indicating it boasts substantial improvement over available therapies on clinically significant endpoints. It also comes after Centers for Medicare & Medicaid Services granted Category B coverage, back in July 2024, for certain expenses incurred by medical centers when treating Medicare or Medicaid patients enrolled in NEUTRALIZE-AKI.
For better understanding, AKI happens to a condition where the patient suffers sudden and temporary loss of kidney function. Post its onset, AKI can cause hyper-inflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Not just that, the damage orchestrated by this condition can also progress to other organs, such as the heart or liver, and potentially cause multi-organ dysfunction or even failure.
Making the disease all the more severe is a fact that, even after resolution, these patients could very well run into complications, such as chronic kidney disease or end-stage renal disease requiring dialysis.
“We are pleased to welcome the 14th hospital to our trial, especially as this site has been among the top CRRT programs in the country,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “As of today, 70 of the planned 200 subjects have been enrolled, including 24 so far in the fourth quarter. We plan to conduct an interim analysis at the trial’s 90-day primary endpoint with the first 100 subjects. Given the current pace of enrollment, we anticipate a Data Safety Monitoring Board (DSMB) recommendation on the interim results by mid-2025.”
In response to AKI’s potentially devastating impact, SeaStar’s SCD presents a patented cell-directed extracorporeal device that is designed to employ an immunomodulating technology. The idea behind that is to selectively target proinflammatory neutrophils and monocytes during CRRT, and therefore, reduce the hyper-inflammatory milieu including the cytokine storm.
More on the same would reveal how SCD is meticulously integrated with CRRT hemofiltration systems to target and transition proinflammatory monocytes to a reparative state, all while getting activated neutrophils to be less inflammatory. Such a distinctive immunomodulation approach is expected, at present, to promote long-term organ recovery and eliminate the need for any future renal replacement treatment (RRT).
Turning our attention towards NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device), it plans on enrolling up to 200 adults. The overarching purpose of this study is to analyze 90-day mortality or dialysis dependency among patients treated with a combination of SCD and CRRT, as compared with the control group receiving only CRRT standard of care.
Beyond that, the study’s secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90, and dialysis dependency at one year. Not just that, the whole exercise will also include subgroup analyses to explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.
“We estimate the annual U.S. total addressable market for the SCD in adult AKI at $4.7 billion to $6.3 billion. This significant market opportunity represents a highly attractive return on a clinical trial estimated to cost SeaStar Medical approximately $15 million, with some of those costs already incurred,” said Eric Schlorff, SeaStar Medical CEO. “AKI is one of several high-value indications for our SCD that we plan to pursue. We believe that our clinical data showing reduced mortality and probable savings for the healthcare system will encourage adoption by the medical community.”