SeaStar Medical Holding Corporation filed a Form 8-K on November 3, 2026, disclosing that the U.S. Food and Drug Administration determined that the QUELIMMUNE Pediatric SAVE Surveillance Registry has fulfilled its post-approval study requirements under the original Humanitarian Device Exemption approval.

Key Highlights

  • FDA Determination: The FDA has determined that the QUELIMMUNE Pediatric SAVE Surveillance Registry ("SAVE Registry") fulfilled post-approval study requirements, according to the filing.
  • Original Approval Framework: The requirements were outlined in the original Humanitarian Device Exemption approval of QUELIMMUNE, the filing states.
  • Event Date: The company issued the press release announcing the FDA determination on November 3, 2026, with the earliest event date reported as October 30, 2026.
  • Common Stock Listed: SeaStar Medical Holding Corporation trades on the Nasdaq Stock Market LLC under the symbol ICU, with warrants trading under ICUCW.
  • Emerging Growth Company: The registrant identified itself as an emerging growth company as defined under applicable SEC rules.

FDA Closes QUELIMMUNE Post-Approval Study Obligation for SeaStar Medical

SeaStar Medical Holding Corporation (NASDAQ:ICU), a Delaware corporation headquartered at 3513 Brighton Blvd, Suite 410, Denver, Colorado 80216, filed a Form 8-K on November 3, 2026, reporting an event dated October 30, 2026. According to the filing, the company issued a press release on November 3, 2026, announcing an FDA determination regarding its QUELIMMUNE product.

The filing disclosed that the United States Food and Drug Administration has determined that the QUELIMMUNE Pediatric SAVE Surveillance Registry, referred to in the filing as the "SAVE Registry," has fulfilled post-approval study requirements as outlined in the original Humanitarian Device Exemption approval of QUELIMMUNE. The disclosure was made under Item 8.01, Other Events. No financial statements accompanied the filing; the sole exhibit listed is the press release dated November 3, 2026 (Exhibit 99.1).

The Form 8-K was signed by Eric Schlorff, Chief Executive Officer, on November 3, 2026. The company's common stock carries a par value of $0.0001 per share, and its warrants, listed under ICUCW, are described as 250 whole warrants exercisable for one share of common stock at $2,875 per share.

What Was Disclosed

SeaStar Medical filed an 8-K disclosing that the FDA determined the QUELIMMUNE Pediatric SAVE Surveillance Registry fulfilled post-approval study requirements tied to the product's original Humanitarian Device Exemption approval, as announced in a press release dated November 3, 2026.