Therapeutic options for critically ill patients experiencing destructive hyperinflammation have shown limited efficacy. Our Selective Cytopheretic Device (SCD) is a patented cell-directed extracorporeal therapy that works with most continuous renal replacement therapy (CRRT) systems to selectively target the most highly activated neutrophils and monocytes responsible for this destructive hyperinflammatory response. The SCD therapy 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.
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 has been granted Breakthrough Device Designations by the U.S. Food and Drug Administration (FDA) for six different indications related to the treatment of destructive hyperinflammation. The designation is designed to provide timely access to medical devices to speed up development, assessment, and review for FDA approval. SCD therapy was approved in 2024 in pediatric AKI due to sepsis and is currently being investigated in adult AKI and other conditions.
SeaStar Medical is now conducting 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.
Primary endpoint: A composite of all-cause mortality or dialysis dependency at day 90.
Secondary endpoints include:
For more information, visit www.clinicaltrials.gov.
SCD-PED therapy has been evaluated in two open-label studies (SCD-PED-01 and SCD-PED-02) in pediatric patients >10kg with AKI requiring continuous kidney replacement therapy (CKRT).
Primary endpoint:
Safety
Secondary endpoints:
Mortality and renal replacement therapy dependency at Day 60
Number of participants:
N=22 (both studies combined)
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 therapy can be easily added to extracorporeal therapies, such as dialysis or continuous renal replacement therapy (CRRT), 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 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.
Early SCD Rationale
SCD Pilot Study
SCD-002 Adult AKI
SCD-003 Adult AKI
SCD-PED-01
Pediatric Study
SCD-005
COVID-19 Study
NEUTRALIZE-AKI
Study Design
Hemolytic Uremic Syndrome
Case Reports
Hepatorenal Syndrome
Case Reports
SCD Safety Summary
in AKI
SCD in Chronic
Heart Failure
SCD-PED-01 & SCD-PED-02
Pooled Analyses
Toxic Shock Syndrome Case Report
SCD in Heart Failure Editorial
SCD in Transplant
SCD Mechanism of Action
Intrigued by the promise of the SCD? Want to know more? We’ll be happy to hear from you.
SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. Our first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA-approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis or a septic-like condition in critically ill pediatric patients. Our Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. We are currently conducting a pivotal trial of our SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually.
©SeaStar Medical 2023