Nuwellis signs exclusive U.S. distribution deal for SeaStar's pediatric kidney device

Nuwellis, Inc.

Nuwellis becomes exclusive U.S. distributor of SeaStar's Selective Cytopheretic Device (SCD) for pediatric acute kidney injury.
Upfront, milestone payments and royalties to SeaStar; initial term 3 years from FDA authorization or first commercial sale.
SeaStar expects FDA HDE review completion Q1 2023; potential commercial launch Q2 2023.
Approximately 4,000 U.S. children annually with AKI require CKRT; mortality rate ~50%.
Automatic one-year extensions possible (max two); termination for uncured material breach.

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

Nuwellis, Inc. entered into Distribution Agreement with SeaStar Medical Holding Corporation valued at upfront payment, milestone payments upon achievement of certain milestones and royalties on gross sa (effective 2022-12-27).

Action: entry
Agreement: license
Counterparty: SeaStar Medical Holding Corporation
Value: upfront payment, milestone payments upon achievement of certain milestones and royalties on gross sa
Effective: 2022-12-27

Exact text from the filing

On December 27, 2022, Nuwellis, Inc. (the “ Company ”) entered into a license and distribution agreement (the “ Distribution Agreement ”) with SeaStar Medical Holding Corporation (“ SeaStar ”), pursuant to which SeaStar appointed the Company as its exclusive distributor for the sale and distribution of SeaStar’s Selective Cytopheretic Device (“ SCD ”) product throughout the United States following the receipt by SeaStar 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 SeaStar. Pursuant to the Distribution Agreement, SeaStar will receive an upfront payment, milestone payments upon achievement of certain milestones and royalties on gross sales of the SCD product.

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Source: SEC EDGAR

accession 0001140361-22-047295

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