---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-314176"
form_type: "8-K"
ticker: "ICU"
cik: "0001831868"
company_name: "SeaStar Medical Holding Corp"
filed_at: "2022-12-29T23:59:59+00:00"
generated_at: "2026-06-20T22:06:18.068534+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# SeaStar Medical enters exclusive U.S. distribution agreement with Nuwellis for SCD device

## Summary
- SeaStar receives upfront payment, milestone payments, and royalties from Nuwellis for exclusive U.S. distribution of SCD for pediatric AKI.
- FDA substantive review of Humanitarian Device Exemption for SCD in children (>20 kg) expected Q1 2023; commercial launch potentially Q2 2023.
- Approximately 4,000 children in U.S. with AKI require CKRT annually; mortality rate is about 50% for these patients.
- SCD selectively targets most activated pro-inflammatory neutrophils and monocytes to stop cytokine storm in critically ill patients.
- Initial term ends 3 years from earlier of 90 days post-FDA authorization or first commercial sale; auto-renews for up to two 1-year terms.

## SEC filing metadata
- accession: 0001193125-22-314176
- form_type: 8-K
- ticker: ICU
- cik: 0001831868
- company_name: SeaStar Medical Holding Corp
- filed_at: 2022-12-29T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 1.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1831868/000119312522314176/0001193125-22-314176-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1831868/000119312522314176/d348126d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-314176
- JSON: https://secwatch.observer/filing/0001193125-22-314176.json
- Plain text: https://secwatch.observer/filing/0001193125-22-314176.txt

## Key facts
- Material Agreements
  SeaStar Medical Holding Corp entered into Distribution Agreement with Nuwellis, Inc. (effective 2022-12-27).
  - Action: entry
  - Agreement: license
  - Counterparty: Nuwellis, Inc.
  - Effective: 2022-12-27
  source text: On December 27, 2022, SeaStar Medical Holding Corporation (the “Company”) entered into a license and distribution agreement (the “Distribution Agreement”) with Nuwellis, Inc. (“Nuwellis”), pursuant to which the Company appointed Nuwellis as its exclusive distributor for the sale and distribution of the Company’s Selective Cytopheretic Device (“SCD”) product throughout the United States following the receipt by the Company from the United States Food and Drug Administration (“FDA”) of a written authorization to market such product for pediatric use pursuant to the Humanitarian Device Exemption application submitted by the Company.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1831868/000119312522314176/0001193125-22-314176-index.htm

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.