Medical device manufacturer SeaStar Medical has reported a substantial four-fold increase in sales for its pediatric acute kidney injury (AKI) treatment QUELIMMUNE, signaling promising growth and potential expansion into the adult medical market.
The company's first quarter financial results reveal a significant milestone in its commercial strategy, with QUELIMMUNE net product revenue rising to $293,000 from $67,500 in the previous quarter. This growth represents a strategic breakthrough in treating a critical pediatric health condition that currently affects approximately 4,000 patients annually in the United States.
QUELIMMUNE, the first FDA-approved treatment under a Humanitarian Device Exemption for pediatric AKI caused by sepsis, offers a potentially life-saving intervention. The treatment's unique capability to connect with existing hospital hemodialysis systems provides a cost-effective solution, with current pediatric AKI hospitalizations averaging $72,460 per patient.
SeaStar Medical is now strategically positioning itself to enter the substantially larger adult AKI market, which the company estimates at $4.5 billion annually. The NEUTRALIZE-AKI pivotal trial, currently 50% enrolled, represents a critical step toward potential FDA approval for adult AKI treatment in 2026.
The company's Selective Cytopheretic Device (SCD) therapy, which underlies QUELIMMUNE, targets destructive hyperinflammatory cells that can cause organ failure in critically ill patients. This innovative approach has already garnered two additional Breakthrough Device Designations, bringing the company's total to six therapeutic indications.
Financial performance also demonstrates the company's improving trajectory. SeaStar's net loss for the first quarter narrowed to $3.8 million, compared to $12.7 million in the same quarter last year. The company concluded the quarter with $5.3 million in cash, supported by a recent $6 million registered direct offering.
With ongoing clinical trials, expanding sales, and a clear market expansion strategy, SeaStar Medical is positioning itself as a potentially transformative player in critical care treatment for both pediatric and adult patients facing acute kidney injury.
