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

SeaStar Medical Holding Corp

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.

item 1.01 item 9.01

Key facts

Extracted from this filing and checked against the source text.

Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.9

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

Exact text from the filing

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.

View on SEC.gov

Browse all material agreements →

SeaStar Medical Holding Corp filing history →

Source: SEC EDGAR

accession 0001193125-22-314176

view filing index on sec.gov

view primary document

Machine-readable: JSON · Markdown · Plain text

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.