Every material Form 8-K SeaStar Medical Holding Corp has filed with the SEC since August 12, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
SeaStar Medical announced that the FDA's Center for Biologics Evaluation and Research determined the QUELIMMUNE Pediatric SAVE Surveillance Registry has fulfilled the post-approval study requirements of the original Humanitarian Device Exemption approval. The company says the decision lets hospitals use QUELIMMUNE without the research infrastructure the registry required, which could expand access for critically ill children with sepsis-associated acute kidney injury. The filing gives no revenue, earnings, or financial figures.
FDA's CBER determined the SAVE Registry met post-approval study requirements, announced November 3, 2026
Registry results showed 90-day survival of 65.1% for QUELIMMUNE patients (N=43) versus 47.5% for comparison patients (N=196), P = 0.043
SeaStar says hospitals may now use QUELIMMUNE without registry research infrastructure; the company will continue voluntary enrollment
SeaStar Medical said holders exercised 854,002 prior warrants for cash at a reduced price of $3.866 per share, for gross proceeds of about $3.3 million before placement agent fees and offering expenses. The offering closed on October 5, 2026, and the company issued new unregistered warrants for up to 1,708,004 shares, which it must register for resale. The filing shows the company will have additional potential share issuance from these new warrants.
854,002 prior warrants exercised at $3.866 per share, versus original exercise prices of $6.38 to $7.62 per share
Gross proceeds of about $3.3 million before placement agent fees and offering expenses; closing occurred October 5, 2026
New unregistered warrants for 1,708,004 shares at $3.616 per share, in two series, with the resale registration to be filed within 30 days of October 2, 2026
H.C. Wainwright & Co. receives a 7.0% cash fee and 1.0% management fee on gross proceeds, plus warrants for 59,780 shares at $4.8325
SeaStar Medical reported second quarter 2026 results, with net revenue of about $0.6 million, up from about $0.3 million a year earlier, driven by growth in QUELIMMUNE sales. The net loss widened to about $3.7 million, or $0.91 per share, from about $2.0 million, or $1.77 per share, as research and development and general and administrative expenses rose, and cash fell to $7.0 million at June 30, 2026 from $12.0 million at December 31, 2025.
Net revenue for the quarter was about $0.6 million versus about $0.3 million in the second quarter of 2025; the company added 3 new QUELIMMUNE customers, bringing the total to 20.
Research and development expenses rose to $2.5 million from $1.0 million, and general and administrative expenses rose to about $1.8 million from $1.0 million.
Net loss was about $3.7 million, or $0.91 per share, on about 4.1 million weighted-average shares, compared with about $2.0 million, or $1.77 per share, on about 1.1 million shares a year earlier.
Cash was $7.0 million at June 30, 2026, down from $12.0 million at December 31, 2025.
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