SeaStar Medical Advances AKI Prevention with Positive Trial Data & Expanded Funding

NEW YORK, NY – November 13, 2025

Financial Health Improves Amidst Clinical Progress

SeaStar Medical (operating as QUELIMMUNE) has reported positive developments on both its financial and clinical fronts. The company announced a net loss of $3.5 million for the three months ended September 30, 2025, an improvement compared to the same period last year. This progress is bolstered by a significantly strengthened cash position, currently at $13.8 million, fueled by $12.4 million raised through equity offerings and warrant exercises. This increased financial flexibility provides a crucial runway for the continued development and expansion of its Selective Cytopheretic Device (SCD) therapy platform, aimed at preventing acute kidney injury (AKI).

According to sources familiar with the company's finances, the recent funding round was strategically timed to support the expanded enrollment of the pivotal NEUTRALIZE-AKI trial and the launch of the NEUTRALIZE-CRS trial. The company is demonstrating a cautious yet optimistic approach to managing expenses while investing in key clinical milestones.

Expanding Clinical Trials & Breakthrough Technology

The company's lead program focuses on addressing AKI, a serious and often overlooked complication impacting millions globally. The NEUTRALIZE-AKI trial, a pivotal study for adult patients requiring continuous renal replacement therapy, has seen its enrollment target expanded to 339 patients following positive interim data reviewed by an independent Data Safety Monitoring Review Board (DSMB). As of mid-November, 146 patients are enrolled, reflecting growing confidence in the therapy's potential.

“The expansion of the NEUTRALIZE-AKI trial is a significant step forward,” commented a key opinion leader in nephrology. “AKI represents a substantial unmet need, and a therapy that can effectively prevent or mitigate its severity would be a game-changer for critically ill patients.”

Alongside the NEUTRALIZE-AKI trial, SeaStar Medical has also initiated the NEUTRALIZE-CRS trial, investigating the use of SCD therapy in patients with acute cardiorenal syndrome awaiting left ventricular assist device (LVAD) implantation. This expansion into a second indication underscores the versatility of the SCD platform and its potential to address a broader spectrum of patients at risk for AKI. The NEUTRALIZE-CRS trial is designed to evaluate if improving cardiac or renal function with the SCD platform can help bridge patients to successful LVAD implantation.

Real-World Evidence Validates Pediatric AKI Therapy

SeaStar Medical’s commitment extends to the pediatric population. The company’s SCD therapy received FDA approval in 2024 under a Humanitarian Device Exemption (HDE) for life-threatening AKI due to sepsis in critically ill children. This approval is contingent on ongoing data collection through the SAVE Surveillance Registry, a real-world evidence (RWE) program designed to confirm the therapy's safety and efficacy. Preliminary results from the registry are highly encouraging, demonstrating a 75% survival rate beyond 28 days in the first 20 patients and, crucially, no device-related safety events. This validates the SCD therapy's impact on a particularly vulnerable patient population, for whom treatment options are severely limited.

“The SAVE Registry is crucial for demonstrating the long-term benefits of this therapy in a real-world setting,” stated an investigator involved in the registry. “Providing effective treatment for pediatric AKI has been a long-standing challenge, and these early results suggest a significant improvement in outcomes.”

Competitive Landscape & Market Potential

The acute kidney injury treatment market is experiencing substantial growth, projected to reach $8.2 billion by 2035, driven by rising rates of chronic diseases, an aging population, and increasing numbers of complex surgical procedures. However, despite the growing market, there remains a significant unmet need for effective preventative therapies. While several companies are exploring novel approaches, SeaStar Medical distinguishes itself with its immunomodulatory SCD platform, targeting the underlying inflammatory drivers of AKI.

“The current standard of care for AKI is largely supportive,” explained a healthcare analyst specializing in nephrology. “A therapy that can proactively prevent AKI or mitigate its severity would fill a critical gap in care.”

The competitive landscape includes AM-Pharma, Sentien Biotechnologies, and several others investigating various therapeutic approaches. However, SeaStar Medical's focus on immunomodulation and its Breakthrough Device Designations provide a competitive edge. Growth markets such as India are also showing promise for expansion, with rising rates of AKI related to cardiovascular issues and increasing surgical procedures.