secwatch.observer — SEC 8-K summary
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Issuer:     Nuwellis, Inc. (NUWE)
CIK:        0001506492
Form:       8-K
Filed at:   2024-07-17T23:59:59+00:00
Accession:  0001140361-24-033362
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Nuwellis announces first commercial sale of QUELIMMUNE therapy for pediatric AKI/sepsis
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- First commercial sale of QUELIMMUNE to Cincinnati Children's Hospital for pediatric AKI/sepsis patients.
- QUELIMMUNE (Selective Cytopheretic Device) developed by SeaStar Medical; early data show 77% survival rate.
- Sale under exclusive US distribution agreement with SeaStar Medical (ICU); FDA Humanitarian Device Exemption.
- Dr. Stuart Goldstein, principal investigator, will integrate QUELIMMUNE as standard of care at Cincinnati Children's.
- CEO Nestor Jaramillo: milestone advances Nuwellis' pediatric business development strategy.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1506492/000114036124033362/0001140361-24-033362-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1506492/000114036124033362/ef20032543_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-24-033362

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