SeaStar Medical (NASDAQ:ICU – Get Free Report) posted its quarterly earnings results on Wednesday. The company reported ($0.80) earnings per share (EPS) for the quarter, beating the consensus estimate of ($0.97) by $0.17, FiscalAI reports. The business had revenue of $0.42 million for the quarter, compared to analysts’ expectations of $0.22 million. SeaStar Medical had a negative return on equity of 237.15% and a negative net margin of 984.60%.
Here are the key takeaways from SeaStar Medical’s conference call:
- SeaStar expanded QUELIMMUNE adoption to 16 top pediatric centers and reported over $1.1M in QUELIMMUNE product revenue for 2025 (Q4 $315k), targeting $2M in product revenue and ~15 additional top children’s hospitals in 2026.
- The NEUTRALIZE-AKI pivotal trial has enrolled 181 of 339 patients (>50%) with enrollment targeted by year-end 2026 and potential top-line results mid-2027, and the company has initiated a modular PMA submission while holding FDA Breakthrough Device designation for the adult AKI indication.
- Post?approval real?world data from the SAVE registry (initial 21?patient publication; 50 patients enrolled) showed no device?related adverse events and encouraging survival (76% at days 28/60; 71% at day 90), supporting QUELIMMUNE safety and adoption in pediatric AKI.
- Financially, SeaStar reported >90% gross margins on product sales, reduced operating expenses (FY2025 $13.4M vs $18M prior year), raised approximately $23.9M of capital in 2025 and ended the year with about $12M cash and no long?term debt.
- Near?term revenue upside is limited by the small pediatric AKI market (~$100M) and the company’s broader commercial opportunity depends on successful adult SCD approval and ongoing funding given 2025 net loss (~$12.2M) versus ~$12M year?end cash.
SeaStar Medical Trading Up 1.4%
NASDAQ ICU opened at $2.83 on Friday. SeaStar Medical has a 12 month low of $2.07 and a 12 month high of $19.07. The stock has a 50-day simple moving average of $2.47 and a 200 day simple moving average of $4.06. The company has a market capitalization of $10.73 million, a PE ratio of -0.34 and a beta of -1.04.
Wall Street Analysts Forecast Growth
View Our Latest Stock Report on ICU
Hedge Funds Weigh In On SeaStar Medical
Institutional investors have recently modified their holdings of the stock. XTX Topco Ltd raised its position in shares of SeaStar Medical by 395.4% in the 2nd quarter. XTX Topco Ltd now owns 60,983 shares of the company’s stock valued at $26,000 after acquiring an additional 48,674 shares during the period. Jane Street Group LLC acquired a new position in SeaStar Medical during the fourth quarter valued at approximately $30,000. Finally, Millennium Management LLC acquired a new position in SeaStar Medical during the third quarter valued at approximately $102,000. 1.69% of the stock is currently owned by institutional investors and hedge funds.
SeaStar Medical Company Profile
SeaStar Medical, Inc (NASDAQ: ICU) is a medical device company focused on the development and commercialization of cerebral embolic protection systems for patients undergoing transcatheter aortic valve replacement (TAVR) procedures. The company’s mission is to reduce the risk of stroke and other neurologic events associated with structural heart interventions by capturing or deflecting embolic debris that can travel to the brain during catheter-based therapies.
The company’s flagship product, TriGUARD® 3, is a next-generation embolic deflection device designed to provide coverage of all three cerebral vessels during TAVR.
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