SeaStar Medical Holding Corporation has reported significant financial developments in its latest 10-K filing for the fiscal year ending December 31, 2025. The company generated revenue of $1.2 million, a substantial increase from $135,000 in the previous year, primarily driven by the adoption of its pediatric Selective Cytopheretic Device (SCD), QUELIMMUNE. The number of active commercial hospital customers rose to ten by the end of 2025, up from three in 2024, reflecting a growing market presence. Despite this revenue growth, SeaStar Medical continues to face challenges, reporting a net loss of $12.2 million for 2025, a decrease from a loss of $24.8 million in 2024.
The company has made strategic advancements, including the FDA's approval of QUELIMMUNE under a Humanitarian Device Exemption in February 2024, marking it as the only FDA-approved product for pediatric patients with acute kidney injury due to sepsis. The company commenced commercial shipments of QUELIMMUNE in July 2024 and is currently conducting a pivotal clinical trial, NEUTRALIZE-AKI, to evaluate the SCD's efficacy in adult patients with acute kidney injury. The SCD has received six Breakthrough Device Designations from the FDA, which are expected to expedite its clinical development and regulatory review.
Operationally, SeaStar Medical has focused on reducing costs, with research and development expenses decreasing by 17% to $7.5 million in 2025, down from $9.1 million in 2024. General and administrative expenses also fell by 34% to $5.8 million, reflecting a concerted effort to streamline operations. The company had a total of 17 employees as of December 31, 2025, and continues to build its internal capabilities following the termination of a distribution agreement with Nuwellis in August 2024.
Looking ahead, SeaStar Medical faces substantial liquidity challenges, with cash reserves of approximately $12 million as of year-end 2025. The company has expressed doubt about its ability to continue as a going concern without additional funding, which it plans to secure through equity or debt financing. The ongoing development of its adult SCD and the commercialization of QUELIMMUNE are critical to its future revenue generation. The company’s financial statements have been prepared on a going concern basis, indicating the need for immediate capital to support its operations and clinical trial activities.
About SeaStar Medical Holding Corp
SeaStar Medical Holding Corporation develops extracorporeal medical devices targeting hyperinflammation and organ failure. Its flagship product, the Selective Cytopheretic Device (SCD), modulates immune cells to treat acute and chronic inflammatory conditions, including acute kidney injury, cardiorenal syndrome, and liver failure. The company focuses on regulatory approval, clinical trials, and strategic partnerships to commercialize its innovative, organ-agnostic therapy for critically ill patients worldwide.
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