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Therapeutic options for critically ill patients with a dysregulated immune response have shown limited efficacy. SeaStar Medical’s Selective Cytopheretic Device (SCD) is a patented cell-directed extracorporeal therapy that works with most continuous kidney replacement therapy (CKRT) systems (and regional citrate anticoagulation) to selectively target the most highly activated neutrophils and monocytes responsible for this hyperactive immune response. SCD technology won’t just stop the storm, but could potentially reverse the damage.
Neutrophils and monocytes are the key immune cells that play a prominent role in life-threatening hyperinflammation.
The novel SCD technology targets and neutralizes activated neutrophils, providing a new therapeutic approach to this problem.1
By restoring reparative physiology, the SCD can help the body heal—potentially reducing mortality, eliminating dialysis dependency and getting patients out of the ICU faster so they can return to their loved ones and daily lives.
Currently, drug treatments for a cytokine storm may differ based on the specific disorder associated with it, and these treatments may not deliver the results your patients need.
Because the SCD is a cell-directed extracorporeal therapy that uses the body’s immune system to heal. You’re in complete control of an effective therapy that can be used without the worry of severe contraindications.
SeaStar Medical is committed to introducing only rigorously researched, clinically validated therapeutic products to the market. And the reason is simple: vital organs and precious lives are at stake. The SCD is recently approved in pediatric AKI due to sepsis and is currently being investigated in adult AKI and other conditions.
SeaStar Medical is now conducting NEUTRophil and Monocyte DeActivation via The SeLective CytopheretIc Device — A RandomiZEd Clinical Trial in Acute Kidney Injury (NEUTRALIZE-AKI) to assess the safety and efficacy of the SCD in critically ill adults with AKI requiring CKRT. The study will assess the effect of SCD treatment on various measures of patient clinical outcomes and evaluate the effect of SCD device on patient safety in SCD treatments from time of initiation through one year.
The primary endpoint is a composite of all-cause mortality or dialysis dependency at day 90.
Secondary endpoints include
For more information, visit www.clinicaltrials.gov.
The Food and Drug Administration (FDA) funded an open-label, multicenter, prospective study of SCD in critically ill children with acute kidney injury (AKI) and multiorgan dysfunction (MOD) requiring CRRT. This is a rare condition for children with few available treatment options.1
The results from this study were presented at the American Society of Nephrology Kidney Week 2020 meeting:
Primary endpoint: Safety
Secondary endpoints: Mortality and renal replacement therapy dependency at Day 60
Number of participants: N=16 meeting the FDA’s target enrollment goal
Results:
There are very few therapeutic options available to treat pediatric AKI…these positive [study] results suggest a favorable benefit to risk ratio in the critically ill pediatric population.
The SCD can be easily added to your extracorporeal therapies, such as dialysis or continuous kidney replacement therapy (CKRT), seamlessly fitting into your workflow. It has been used with other treatments, including IL-6 blockers, corticosteroids and other common treatments, with no or few known contraindications.
By giving your critically ill patients the potential to eliminate dialysis dependency, get out of the ICU faster, and restore the lives they were so close to losing, the SCD is positioned to become the new standard of care in the ICU.
Intrigued by the promise of the SCD? Want to know more? We’ll be happy to hear from you.
References: 1. Goldstein SL, Askenazi DJ, Basu RK, et al. Use of the Selective Cytopheretic Device in Critically Ill Children. Kidney International Reports. 2020. https://doi.org/10.1016/j.ekir.2020.12.010. 2. Tumlin JA, Galphin CM, Tolwani AJ, et al. A multi-center, randomized, controlled, pivotal study to assess the safety and efficacy of a selective cytopheretic device in patients with acute kidney injury. PLoS One. 2015;10(8):e0132482. PMID: 26244978.
The SCD is an investigational device and is not currently available for sale. Please check back for further updates on device availability in your region.
SeaStar Medical is a medical technology company that is redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical’s novel technologies provide life-saving solutions to critically ill patients. We are developing and commercializing cell-directed extracorporeal therapies that target the key immune cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses.
©SeaStar Medical 2023