SeaStar Medical Holding Corporation, (ICU) a commercial-stage medical device company reported fourth quarter results reflecting a narrower net loss backed by revenue growth. In addition, it also provided business updates on its flagship therapies QUELIMMUNE and NEUTRALIZE-AKI.
Following the news, ICU is surging 21.66% to $2.77.
The Company ProfileSeaStar Medical develops a proprietary platform therapy to reduce the consequences of hyperinflammation on vital organs under therapeutic areas including Acute Kidney Injury, Cardiorenal Syndrome, Hepatorenal Syndrome, and Myocardial Stunning in end-stage Renal disease.
The firm's core technology platform is a selective cytopheretic device (SCD), a disease-modifying device that neutralises overactive immune cells and stops the cytokine storm that yields destructive hyperinflammation.
SeaStar Medical's first commercial product, QUELIMMUNE, was approved by the FDA for Acute Kidney Injury (AKI) due to sepsis or a septic condition requiring renal replacement therapy (RRT) in critically ill paediatric patients.
AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as severe infections or other septic conditions, severe trauma, surgery, and organ failures. The firm also develops NEUTRALIZE-AKI, an SCD therapy that is in clinical trials for adult patients with AKI.
Fourth Quarter Results
For the fourth quarter, net loss narrowed to $2.90 million or $0.80 per share from $4.41 million, or $8.98 per share in the prior year.
Net revenue climbed to $420 thousand compared to $67 thousand in the last year, mainly driven by QUELIMMUNE sales.
FY25 ResultsFor 2025, net loss narrowed to $12.15 million, or $5.86 per share from $24.83 million, or $66.33 per share in the prior year.
Net revenue jumped to $1.23 million from $135 thousand in the last year.
As of December 31, the firm had cash of $12.0 million compared to $1.8 million a year ago.
Milestones Ahead
The company is currently enrolling for NEUTRALIZE-AKI pivotal trial which evaluates the safety and efficacy of the SCD therapy in 339 adults with AKI in the ICU receiving continuous renal replacement therapy.
The company noted that it has enrolled 181 adult AKI patients to date out of 339 in the NEUTRALIZE-AKI pivotal trial, representing enrolment above 50%.
Also looking ahead Seastar Medical anticipates,
-To expand QUELIMMUNE adoption to include 15 additional top-ranked children's medical centers and expects achieving approximately $2 million in net product revenue in 2026.
-Advance the SCD therapy for the adult AKI indication through completion of enrollment in the NEUTRALIZE-AKI pivotal trial around the end of 2026.And begin submission of relevant PMA modules to the FDA to facilitate the PMA review and approval process.
-Evaluate broader applicability of the SCD therapy by conducting a pivotal trial of the SCD therapy in patients with acute chronic heart failure with cardiorenal syndrome awaiting left ventricle assist device implantation.
-Explore rapid regulatory pathways to commercialization of the SCD therapy in numerous destructive hyperinflammatory conditions.
Conclusion"The adult AKI patient population is approximately 50 times larger than the pediatric AKI market in the U.S. alone. It is the core market that we believe will drive significant revenue expansion for the company." said Eric Schlorff, CEO of SeaStar Medical.
ICU has traded between $2.09 and $25.70 in the last year. The stock closed Wednesday's trade at $2.28.
For comments and feedback contact: editorial@rttnews.com
Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.