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for healthcare professionals

Category: SCD-ADULT

SCD-003: SCD Use in Adult AKI

SCD-002: SCD Use in Adult AKI

SCD Pilot Study

Early SCD Rationale

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.

The Problem
Our Solution
QUELimmune
Pipeline
About
Investors
News
Contact

The Problem
Our Solution
QUELimmune
Pipeline
About
Investors
News
Contact

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Privacy Policy
Terms and Conditions

Address:
3513 Brighton Blvd
Suite 410
Denver, CO 80216

Phone:
844-427-8100

Email:
info@seastarmed.com

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