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DENVER - SeaStar Medical Holding Corporation (NASDAQ:ICU), a healthcare company specializing in treatments for critically ill patients with organ failure, has announced that the U.S. Centers for Medicare & Medicaid Services (CMS) will cover certain expenses for Medicare and Medicaid patients participating in the NEUTRALIZE-CRS clinical trial. This decision follows a similar CMS reimbursement for the NEUTRALIZE-AKI trial in July 2024.
The NEUTRALIZE-CRS trial will investigate the efficacy of SeaStar Medical’s Selective Cytopheretic Device (SCD) therapy in reducing hyperinflammation in adult patients with acute heart failure. The study is expected to enroll 20 patients across up to five clinical sites, supported by a $3.6 million National Institutes of Health (NIH) grant. While the company reported revenue of just $430,000 in the last twelve months, analysts tracked by InvestingPro forecast sales growth of 7.5% for the current fiscal year.
SeaStar Medical’s SCD therapy, which has received Breakthrough Device Designation from the FDA for adult patients with Acute Kidney Injury (AKI) and Continuous Renal Replacement Therapy (CRRT), aims to mitigate the cytokine storm associated with hyperinflammation. The NEUTRALIZE-AKI trial, halfway enrolled with a primary endpoint of 90-day mortality or dialysis dependency, is also evaluating the SCD therapy’s safety and efficacy.
CEO Eric Schlorff expressed that CMS’s coverage is a testament to the potential life-saving capabilities of their technology. The company is also preparing for potential commercialization, including engaging a third-party reimbursement policy expert to support their case for CMS and private payer coverage following FDA approval.
SeaStar Medical’s first commercial product, QUELIMMUNE (SCD-PED), was FDA approved in 2024 for severe acute kidney injury in critically ill pediatric patients. The company’s SCD therapy holds Breakthrough Device Designation for six therapeutic indications, which may facilitate a faster FDA approval process and favorable reimbursement scenarios.
This announcement is based on a press release statement from SeaStar Medical. The company cautions that forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from those projected. The stock has faced significant challenges, declining 87% over the past year, though InvestingPro analysis suggests the company is currently trading below its Fair Value. Investors seeking deeper insights can access comprehensive financial health metrics and additional ProTips through InvestingPro’s detailed research reports, available for over 1,400 US stocks.
In other recent news, SeaStar Medical Holding Corp. reported a significant increase in revenue for the first quarter of 2025, reaching $293,000, which marks a fourfold rise from the previous quarter. The company also managed to reduce its net loss to $3.7 million, a notable improvement from the $12.7 million loss reported in the same period last year. SeaStar Medical’s financial position is bolstered by $5.3 million in cash, supporting ongoing operations and clinical trials. The company announced the addition of a new prestigious children’s hospital to its customer list and achieved 50% enrollment in its Neutralize AKI trial. Furthermore, SeaStar Medical received two new breakthrough device designations from the FDA, expanding its pipeline indications. The company aims to complete the Neutralize AKI pivotal trial and is targeting a PMA filing in 2026. Analysts have shown optimism, with the company reporting increased interest and adoption of its Quellimmune therapy in pediatric AKI markets.
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