SeaStar Medical Expands QUELIMMUNE Accessibility to Hospitals

SeaStar Medical Initiates Shipments of QUELIMMUNE to New Hospitals

SeaStar Medical Holding Corporation (Nasdaq: ICU), a pioneering entity in medical device technology, is thrilled to announce its expanding reach with the shipment of its QUELIMMUNE device to another distinguished academic medical center. This marks the company’s fourth commercial client, demonstrating its growing impact on improving patient care for critically ill children suffering from acute kidney injury (AKI) and sepsis.

Promoting Innovative Solutions for Pediatric Patients

Tim Varacek, Senior Vice President of Commercial & Business Operations at SeaStar, expressed enthusiasm about this advancement. “We are committed to broadening the accessibility of QUELIMMUNE, and we take immense pride in being the sole firm to develop and market a therapeutic device that shows effective clinical outcomes in reducing mortality rates and minimizing dialysis reliance for these vulnerable pediatric patients,” he stated.

Understanding QUELIMMUNE's Impact on Healthcare Costs

Continuing the discussion on the device’s benefits, CEO Eric Schlorff highlighted QUELIMMUNE’s potential to also lower healthcare expenses. “Our research indicates that patients with AKI who received the Selective Cytopheretic Device (SCD) had no dependence on dialysis just 60 days post-treatment. Given the annual cost for a single dialysis patient is approximately $100,000, this elimination of expenses illustrates substantial savings for the healthcare system,” he added. QUELIMMUNE’s capabilities may extend beyond individual patient care; it could help in shortening hospital stays, thereby reducing the frequency of readmissions and emergency visits.

The Medical Landscape: Acute Kidney Injury and Hyperinflammation

Acute kidney injury, marked by a sudden loss of kidney function, often follows severe health conditions like trauma, surgery, or infections such as COVID-19. Such injuries can trigger hyperinflammation—a state where excess inflammatory response leads to further organ damage. This cascading effect can cause additional complications, risking multi-organ dysfunction and significantly affecting patient recovery and overall healthcare costs.

Selective Cytopheretic Device: A Unique Therapeutic Tool

The Selective Cytopheretic Device (SCD) represents SeaStar Medical’s innovative approach, utilizing advanced technology to mitigate hyperinflammation. This patented device works alongside renal replacement therapy, targeting harmful inflammatory cells while promoting healthier immune responses. The ultimate goal is to foster organ recovery and decrease the necessity for prolonged treatment options, including dialysis.

FDA Recognition and Future Directions for QUELIMMUNE

QUELIMMUNE has already received FDA approval, catering to children with AKI weighing at least 10 kilograms in intensive care settings. Its approval was granted under a Humanitarian Device Exemption due to the demonstrated safety and possible benefits for this critical patient demographic. As SeaStar Medical continues to innovate, the SCD has garnered the FDA's Breakthrough Device Designation across multiple clinical scenarios, which showcases its potential in addressing significant medical challenges.

A Glimpse into SeaStar Medical's Vision

SeaStar Medical is reshaping the landscape of medical technology by focusing on how extracorporeal therapies can mitigate the ramifications of overwhelming inflammation on essential organs. Their cutting-edge solutions are geared towards offering critical care options to patients facing dire conditions. The company is dedicated to advancing technologies that fundamentally alter treatment pathways for systemic inflammation management.

Frequently Asked Questions

What is QUELIMMUNE?

QUELIMMUNE is a Selective Cytopheretic Device designed for treating critically ill children suffering from acute kidney injury and sepsis.

How does QUELIMMUNE impact healthcare costs?

The device has been shown to reduce the dependency on costly dialysis treatments, potentially saving the healthcare system significant expenses.

Who is SeaStar Medical?

SeaStar Medical Holding Corporation is a commercial-stage medical technology company focused on creating therapies to lessen the impact of inflammation on vital organs.

What regulatory approval does QUELIMMUNE hold?

QUELIMMUNE is approved by the FDA under a Humanitarian Device Exemption for use in pediatrics with AKI.

What are the benefits of using the Selective Cytopheretic Device?

The device promotes a healthier immune response, aiding in organ recovery and potentially lessening the need for further renal replacement therapies.

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