DETROIT, MICHIGAN - May 29, 2025 (NEWMEDIAWIRE) - SeaStar Medical Holding Corporation (NASDAQ: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, is seeing double-digit growth in sales of QUELIMMUNE, which drove revenues for the company in the first quarter of 2025.
QUELIMMUNE is the company's first FDA-approved product that was approved under a Humanitarian Device Exemption (HDE) to treat pediatric patients with acute kidney injury (AKI) due to sepsis or a septic condition. The first quarter of 2025 marked the second full quarter in which QUELIMMUNE was available for sale.
"This is our second full quarter of the QUELIMMUNE launch and we believe our four-fold increase in revenue represents the strong commitment by our customers to improve outcomes in their pediatric patients with Acute Kidney Injury (AKI) with this potential life-saving therapy," said Eric Schlorff, CEO of SeaStar Medical when reporting first quarter results. "We also continue to attract new customers, including a nationally recognized children's medical center that just completed Institutional Review Board (IRB) approvals and placed its first order for the QUELIMMUNE therapy." SeaStar said its pipeline of potential customers is expanding, and it should have QUELIMMUNE in multiple new sites by the end of 2025.
The pediatric AKI market is a small market, but SeaStar now has its sights set on the much larger adult AKI market. The company reported that its NEUTRALIZE-AKI pivotal trial in adults with AKI and continuous renal replacement therapy (CRRT) is 50% enrolled, and if all goes as planned, it hopes to file for approval for the adult AKI indication in 2026. SeaStar estimates that this total U.S. market opportunity is $4.5 billion annually, or 50 times larger than the pediatric AKI market.
Fourfold Increase In QUELIMMUNE Sales
For the three months ended March 31, 2025, SeaStar Medical reported a fourfold increase in QUELIMMUNE net product revenue to $293,000 compared to $67,500 in the fourth quarter of 2024.
"We are clearly seeing that once adopted, customers are experiencing organ-sparing and life-saving outcomes from using the QUELIMMUNE therapy in their pediatric AKI patients," said Schlorff at an earnings call to discuss first quarter results. "As we grow our customer base, we believe we can drive meaningful revenue from this small but important market of about 4,000 patients annually in the U.S."
QUELLIMUNE is connected in-line to an existing hemodialysis delivery system's extracorporeal continuous kidney replacement therapy (CKRT) circuit. What makes QUELIMMUNE so promising, reports SeaStar, is that it can connect to existing workflows in hospitals, keeping costs at bay. Pediatric AKI costs U.S. hospitals an average of $72,460 per patient, which is 8% higher than costs related to other hospitalizations. QUELIMMUNE is the only FDA-approved product for the condition of life-threatening AKI due to sepsis or a septic condition in critically ill pediatric patients, reports SeaStar.
Other highlights for the quarter included three new QUELIMMUNE customer wins including a nationally recognized children's medical center that recently completed IRB approvals and placed an initial order for QUELIMMUNE therapy and achieving 50% enrollment target in the NEUTRALIZE-AKI trial.
The company also received two new Breakthrough Device Designations for use of its SCD therapy in both adult and pediatric patients bringing its total Breakthrough Device Designations to six therapeutic indications and the FDA also granted an Investigational Device Exemption (IDE) for a clinical trial to evaluate the SCD therapy as a bridging strategy to left ventricular assist device (LVAD) implantation in patients with chronic heart failure who have progressed to acute decompensated heart failure.
SeaStar's net loss for the first quarter narrowed to about $3.8 million, or $0.44 per share. That compares with a net loss of approximately $12.7 million, or $4.73 per share, in the year-ago first quarter. General and administrative expenses for the quarter were lower at approximately $1.7 million, compared to $2.34 million in the year-ago quarter.
The medical device maker ended the quarter with $5.3 million in cash, up from $1.8 million as of the end of December. In January, Sea Star announced a $6 million registered direct offering priced at-the-market.
Setting Its Sights On The Adult Market
With its NEUTRALIZE-AKI trial well underway, SeaStar is beginning its pre-commercialization efforts to expand its product offering into the adult market. Its Selective Cytopheretic Device (SCD) therapy, which underpins QUELIMMUNE, neutralizes destructive hyperinflammatory cells, particularly neutrophils and monocytes that, when left unchecked, can cause organ failure and loss of life in critically ill patients.
The NEUTRALIZE-AKI trial is evaluating the safety and efficacy of its second proprietary SCD therapy in 200 adults with AKI in the intensive care unit (ICU) receiving continuous renal replacement therapy (CRRT). The NEUTRALIZE-AKI trial reached the 50% enrollment target, which the company says is a milestone that triggered the interim analysis by the trial's independent Data Safety Monitoring Board, or DSMB. SeaStar Medical anticipates the DSMB will report its findings to the company in the third quarter of 2025.
"Completing the NEUTRALIZE-AKI trial and potentially obtaining approval are key near-term milestones for us," says Schlorff. "We are very excited about this market opportunity and are already engaging with physicians and health care providers on the Medical Affairs side to educate them about the SCD therapy and data that support its use as a potential treatment for patients with AKI and CRRT."
Looking out to the coming quarters, SeaStar said it is focused on new customer acquisitions, completing its NEUTRALIZE-AKI pivotal trial and preparing to file a PMA following the completion of the adult AKI pivotal trial.
With sales of QUELIMMUNE expanding and its trial for adult AKI underway, SeaStar is working hard toward continued growth as it seeks to use its therapy to spare organs and save lives in critically ill children and adults.
