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June 8, 2022

SeaStar reports data from immunomodulator device study

The pilot study assessed the safety and efficacy of the SCD in Covid-19 ICU patients with multiple organ failure.

SeaStar Medical and LMF Acquisition Opportunities have reported data from the SCD 005 clinical study of the use of SeaStar Medical’s Selective Cytopheretic Device (SCD) in treating Covid-19 patients suffering from multiple organ failure and admitted to the intensive care unit (ICU).

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A cell-directed, patented, extracorporeal immunomodulator, the SCD has been designed to address hyperinflammation with selective targeting of activated neutrophils and monocytes.

The multi-centre pilot study has been designed to evaluate the SCD’s safety and efficacy in 22 Covid-19 patients either with acute kidney injury (AKI) or acute respiratory distress syndrome (ARDS).

The company stated that the SCD was integrated into a continuous renal replacement therapy (CRRT) blood circuit in the study.

During the study, patients were treated for up to 10 days, with a new SCD placed in the circuit every 24 hours or as required.

Reductions were observed in activated neutrophils and monocytes, which in turn led to a reduction in proinflammatory cytokines and improved clinical outcomes in patients.

SeaStar Medical said that subjects who received SCD treatment had a reduction in 60-day mortality to 50%, as against 81% in the control group.

The SCD-treated subjects who received more than 96 hours of treatment had a further reduction in mortality to 31% (p < 0.012).

SeaStar Medical president and CEO Eric Schlorff said: “Hyperinflammation can be a devastating factor for severe Covid patients who develop multi-organ complications.

“This pilot study helps inform our upcoming pivotal study, which will examine how our immunomodulatory therapeutic treatment can be disease-agnostic in its efforts to return a pro-inflammatory immune system back to a reparative state.”

The company also stated that the SCD treatment in Covid-19 ICU patients with multiple organ failure showed an acceptable safety profile, with no serious adverse events associated with the device.

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Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
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