SeaStar Medical Raises Revenue 247% to $635,000 in Third Quarter of 2026

Key Facts

SeaStar Medical said on November 11 that net revenue reached $635,000 in the third quarter of 2026, up 247% year over year, driven by sales of its QUELIMMUNE therapy. Therapy sales were $635,000, compared with $183,000 in the same period of 2025, according to the company's quarterly results statement. The company said gross margin remained above 90% during the quarter. Despite revenue growth, net loss rose to $4.5 million from $3.5 million a year earlier. The results put the commercial product's performance alongside the cost of continuing development of the company's clinical program.

Diluted loss per share was $1.03 in the third quarter, compared with $1.30 in the corresponding quarter of 2025. Research and development expenses rose to $3.6 million from $1.9 million a year earlier. The company attributed the increase mainly to clinical-trial activity related to the NEUTRALIZE-AKI study, development costs for the SCD device, as well as personnel and salaries. In the second quarter of 2026, the company reported revenue of $615,000, up 82% year over year, and a net loss of about $3.7 million, compared with about $2 million in the second quarter of 2025. For the first half, revenue was $1.11 million, versus $631,000, an increase of 76% from the corresponding period.

The company ended September with $4 million in cash and cash equivalents, according to its statement, excluding about $3.3 million in gross proceeds from the exercise of warrants in October. SeaStar had forecast in its 2025 results that it would generate about $2 million in net product revenue during 2026. The third-quarter results provide a measure of progress toward that forecast, with QUELIMMUNE alone recording sales of $635,000 in the quarter. The company's shares, which trade under the ticker ICU, closed at $1.90 on November 10, according to EL7 data. That close reflects a session before the third-quarter results announcement scheduled for the following day.

QUELIMMUNE is the company's first commercial product and is based on SCD device technology. It received U.S. Food and Drug Administration approval in 2024 to treat sepsis-associated acute kidney injury or septic conditions in critically ill children. On November 3, the FDA confirmed that the SAVE registry met the post-approval study requirements set out in the product's original approval. SeaStar said the decision allows hospitals to use the therapy without the research infrastructure required by the SAVE registry. The company also said ICD-10-PCS codes designated for SCD therapy took effect on October 1, 2026. The codes enable administrative reporting, billing and statistics for hospital use of the therapy in patients with acute kidney injury who receive renal replacement therapy.

The company presented SAVE registry results for 50 children with sepsis-associated acute kidney injury and said the QUELIMMUNE group showed statistically significantly higher survival at day 60, day 90 and hospital discharge compared with control groups. In the day 90 analysis published in October, survival was 65.1% in the group that received the therapy, versus 47.4% in the comparison group, with a statistical p-value of 0.043. The company described the analysis as exploratory, based on an observational external comparison of eligible patients who received the therapy. It said final results and their interpretation are expected in a peer-reviewed scientific manuscript. The data provide clinical context for the pediatric product, while the adult program remains in a pivotal study.

In its adult program, SeaStar said the pivotal NEUTRALIZE-AKI trial had enrolled 251 of a targeted 339 patients as of November 11. The company expects enrollment to be completed by mid-2027. It submitted the first module of a premarket approval application to the FDA for its potential SCD therapy for adults with acute kidney injury in intensive care who receive continuous renal replacement therapy. The company scheduled its third-quarter results announcement for November 11, with an investor call at 4:30 p.m. Eastern time. Earlier, the stock rose 25.1% in the October 2 session, while the S&P 500 gained 0.7% in the same session.