Seastar Medical Holding Corporation ((ICU)) announced an update on their ongoing clinical study.
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Seastar Medical Holding Corporation is conducting a study titled ‘Pediatric Selective Cytopheretic Device (SCD-PED, QUELIMMUNE) for Critically Ill Children With Acute Kidney Injury: A Humanitarian Device Exemption (HDE) Surveillance Registry Protocol.’ The study aims to collect safety data on the QUELIMMUNE device, approved under an HDE for pediatric patients with acute kidney injury (AKI) due to sepsis. The key objective is to compare the incidence of new bloodstream infections within 28 days of treatment with a matched group not using the device.
The intervention being tested is the QUELIMMUNE (SCD-PED) device, a medical device intended for use in treating pediatric patients with AKI as part of standard clinical practice under the HDE approval.
This observational study follows a case-control model with a prospective time perspective. It aims to include all patients treated with the QUELIMMUNE device under the approved HDE indication, focusing on collecting and comparing safety data.
The study began on July 18, 2024, with the latest update submitted on October 22, 2025. These dates are crucial as they mark the study’s progression and ongoing data collection efforts.
The market implications of this study could be significant for Seastar Medical Holding Corporation, potentially affecting its stock performance and investor sentiment. The study’s outcome might influence the competitive landscape in the medical device industry, particularly in the treatment of pediatric AKI.
The study is currently ongoing, with further details available on the ClinicalTrials portal.