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 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 COVID-19, sepsis, severe trauma and surgery. AKI can cause hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face chronic kidney disease or end-stage renal disease requiring dialysis, among other complications. Hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.

SeaStar Medical's Selective Cytopheretic Device (SCD)

QUELIMMUNE is the brand name for the Selective Cytopheretic Device (SCD) Pediatric. The SCD is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous kidney replacement therapy (CKRT) and reduces the hyperinflammatory milieu including the cytokine storm. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CKRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future KRT, including dialysis. In addition to the approval of QUELIMMUNE in pediatric AKI, the SeaStar Medical SCD was awarded Breakthrough Device Designation in three additional indications:

• Cardiorenal Syndrome – Left Ventricular Assist Device (CRS-LVAD)
• Adult Acute Kidney Injury (AKI)
• Hepatorenal Syndrome (HRS)
  
  

QUELIMMUNE

QUELIMMUNE is being commercialized following FDA approval under a Humanitarian Device Exemption (HDE) application in February 2024 for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with KRT. SeaStar Medical met the applicable criteria for the HDE award with clinical results showing safety and probable clinical benefit in a limited population of critically ill children with AKI who had few treatment options. Each year in the U.S. approximately 4,000 children with AKI require CKRT and those patient profiles are associated with high mortality. The mortality rate in children with AKI requiring CKRT is approximately 50 percent. Children who survive an AKI episode are at risk for long-term conditions, including chronic kidney disease (CKD). Pooled analysis from two non-controlled studies, SCD-PED-01 (funded by the FDA Office of Orphan Products Development) and SCD-PED-02, showed that pediatric patients 10 kilograms or more with AKI requiring CKRT treated with the QUELIMMUNE pediatric device had no device-related serious adverse events or device-related infections, a 77% reduction in mortality rate, and no dialysis dependency at Day 60.

About SeaStar Medical

SeaStar Medical is a commercial-stage medical technology company that is redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical's novel technologies rely on science and innovation to provide life-saving solutions to critically ill patients. The Company is developing and commercializing cell-directed extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses. For more information visit www.seastarmedical.com or visit us on LinkedIn or X.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements include, without limitation, the amount and timing of future QUELIMMUNE commercial sales; the ability of SeaStar Medical to meet the demand for and the revenue recognition on QUELIMMUNE commercial sales; commercial acceptance of QUELIMMUNE; the ability of SCD to treat patients with AKI and other diseases; anticipated patient enrollment and the expansion of the clinical trial sites; the expected regulatory approval process and timeline for commercialization; and the ability of SeaStar Medical to meet the expected timeline. Words such as "believe," "project," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical's control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to access funding under existing agreements; (vi) the risk that third-parties suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical's products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical's Annual Report on Form 10-K, including those under the "Risk Factors" section therein and in SeaStar Medical's other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.

Contact:

LHA Investor Relations

Jody Cain

(310) 691-7100

[email protected]

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