Business
SeaStar Medical to Distribute QUELIMMUNE Directly to Hospital Customers
DENVER, Oct. 22, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary
About this update from Seastar Medical Holding Corporation
[{"type":"text","content":"DENVER, Oct. 22, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that it has assumed all responsibility for direct sales, marketing and distribution of QUELIMMUNE™ to hospital customers. QUELIMMUNE is SeaStar Medical’s therapeutic device approved for the treatment of pediatric acute kidney injury (AKI) due to sepsis or a septic-like condition. “The SeaStar Medical team is focused on a successful commercial rollout with this game-changing therapy, QUELIMMUNE, to treat severely ill children. We have the infrastructure and operational capabilities in place to market and ship QUELIMMUNE directly to hospital customers and are confident we can seamlessly fulfill customer demand now and in the future,” said Eric Schlorff, SeaStar Medical CEO. “We are streamlining the ongoing business relationships with Institutional Review Board (IRB) processes with pediatric hospitals committed to bringing QUELIMMUNE into their institutions under the U.S. Food and Drug Administration (FDA) Humanitarian Use Device (HUD) requirements. Our clinical training team works directly with physicians and patient care teams in the intensive care units (ICUs) to integrate QUELIMMUNE into existing hemofiltration systems.” “SeaStar Medical now has the flexibility to build the QUELIMMUNE business with our commercial infrastructure and explore new strategic partnerships that align with our interests and can accelerate the adoption of this life-saving technology to a critically ill population of children,” said Tim Varacek, SeaStar Medical Senior Vice President, Commercial & Business Operations. “We are pleased with the initial demand from our first customer, Cincinnati Children’s, which has exceeded our expectations with multiple reorders of QUELIMMUNE. We anticipate more demand for QUELIMMUNE in the coming months as additional hospitals are cleared for its use.” Going forward, SeaStar Medical will recognize 100% of revenue generated from QUELIMMUNE sales in the U.S., which corresponds to 3x-4x times more revenue per unit. Acute Kidney Injury (AKI) and Hyperinflammation AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as C...