secwatch.observer — SEC 8-K summary
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Issuer:     SeaStar Medical Holding Corp (ICU)
CIK:        0001831868
Form:       8-K
Filed at:   2022-12-29T23:59:59+00:00
Accession:  0001193125-22-314176
Event type: other_material
Sentiment:  positive
Materiality: 0.90
Item codes: 1.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1831868/000119312522314176/0001193125-22-314176-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1831868/000119312522314176/d348126d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-314176

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer