SeaStar Medical Holding Corporation (NASDAQ: ICU) announced significant advancements in its pivotal trial. The news sparked a 13.50% rise in ICU stock, sending its price to $2.69 during after-market trading on Tuesday.
New Site Activation and Enrollment Milestone
SeaStar Medical (ICU) has activated Sentara Norfolk General Hospital in Norfolk, Virginia, marking the thirteenth active site in its ongoing trial. Nine severely sick adult patients were joined in November alone, increasing the total number of participants to 65. The NEUTRALIZE-AKI research aims to evaluate the safety and efficacy of the company’s proprietary Selective Cytopheretic Device (SCD) in 200 adult patients requiring continuous renal replacement therapy (CRRT) in critical care units.
The study’s momentum has accelerated with twice of the patient enrollments in the first two months Q4 than those in the first three quarters of 2024. With plans to activate additional sites in December, SeaStar Medical is poised to meet its enrollment goals ahead of schedule.
SCD’s Potential to Transform AKI Treatment
Pilot trials have revealed that the SCD can save lives and lessen dialysis dependency in patients who are in severe condition. These results demonstrate the device’s potential to lessen the strain on healthcare systems while simultaneously improving patient outcomes.
About 210,000 patients in the United States are estimated by SeaStar Medical to be addressable AKIs per year, which translates to a $1 billion peak sales potential for the SCD. Beyond AKI, the company plans to expand its focus to other hyperinflammatory conditions, including cardiorenal syndrome.
Regulatory and Financial Support
The U.S. Food and Drug Administration previously awarded the SCD Breakthrough Device Designation, highlighting its potential to treat life-threatening illnesses with significant advancements over existing treatments. In July 2024, the Centers for Medicare & Medicaid Services granted Category B coverage for certain expenses related to the NEUTRALIZE-AKI trial, further supporting the study’s financial viability and its critical role in advancing healthcare solutions.
