FDA Cuts SAVE Registry Requirement to 50 Patients for SeaStar Medical’s QUELIMMUNE Therapy

Reuters12-02
FDA Cuts SAVE Registry Requirement to 50 Patients for SeaStar Medical's QUELIMMUNE Therapy

SeaStar Medical Holding Corporation announced that the U.S. Food and Drug Administration (FDA) has approved a reduction in the mandatory enrollment size of the SAVE Surveillance Registry for its QUELIMMUNE therapy, from 300 patients to 50 patients. This decision follows an assessment of data from the first 21 patients, which showed no device-related adverse events and improved survival rates. The FDA's approval of the smaller registry fulfills the post-approval surveillance requirement under the original Humanitarian Device Exemption (HDE) and is expected to accelerate adoption of QUELIMMUNE for pediatric acute kidney injury (AKI), potentially expanding SeaStar Medical's market opportunity. No other organizations are mentioned as recipients of this regulatory approval.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Seastar Medical Holding Corporation published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9595017-en) on December 02, 2025, and is solely responsible for the information contained therein.
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