SeaStar Medical Begins Shipping QUELIMMUNE to a Fourth Hospital Customer

Rhea-AI Summary

SeaStar Medical (Nasdaq: ICU) has expanded its commercial reach by shipping its QUELIMMUNE™ device to a fourth hospital customer, a prominent academic medical center. QUELIMMUNE is a Selective Cytopheretic Device (SCD) designed to treat critically ill children in ICU with acute kidney injury (AKI) and sepsis.

The device, approved by FDA under Humanitarian Device Exemption, has shown clinical benefits in reducing mortality and decreasing dialysis dependency. According to company data, AKI patients treated with SCD showed no dialysis dependency 60 days post-treatment, potentially saving approximately $100,000 per patient annually in dialysis costs. The average hospital cost per pediatric ICU patient with AKI requiring continuous renal replacement therapy exceeds $350,000.

QUELIMMUNE is approved for children weighing 10 kilograms or more who require renal replacement therapy. The SCD technology uniquely targets proinflammatory neutrophils and monocytes during continuous renal replacement therapy, potentially promoting long-term organ recovery.

Positive

• Fourth commercial customer acquisition shows market expansion
• Clinical data demonstrates elimination of dialysis dependency after 60 days
• Potential cost savings of $100,000 per patient annually from eliminated dialysis needs
• FDA Breakthrough Device Designation in four additional indications

Negative

• market scope due to Humanitarian Device Exemption approval
• Product restricted to patients weighing 10 kilograms or more

Insights

Medical Device Analyst

SeaStar Medical's expansion to a fourth hospital customer for QUELIMMUNE represents modest but strategic commercial traction in a critical therapeutic area. The device's unique position as the only FDA-approved therapeutic solution for pediatric AKI and sepsis patients creates a compelling market opportunity. The demonstrated clinical benefits of reducing mortality and dialysis dependency are backed by significant cost-saving potential - $100,000 per patient annually in avoided dialysis costs and potential reduction in the $350,000 average ICU stay costs.

The HDE approval pathway, while limiting the addressable market, provides a strategic entry point for broader commercial expansion. The multiple Breakthrough Device Designations across four additional indications suggest substantial growth potential beyond the current pediatric AKI focus. The device's integration with existing CRRT systems and unique immunomodulation mechanism offers a competitive advantage over traditional blood purification approaches.

Healthcare Economics Expert

The economic value proposition of QUELIMMUNE is compelling from a healthcare system perspective. The device addresses a high-cost patient population where the average ICU stay exceeds $350,000. The elimination of long-term dialysis dependency, valued at $100,000 per patient annually, presents significant recurring cost savings. Beyond direct treatment costs, the potential reduction in length of stay, readmissions and post-acute care visits multiplies the economic benefit.

For hospital administrators, the device's ability to integrate with existing CRRT systems minimizes additional infrastructure investments. The demonstrated clinical outcomes in reducing mortality and dialysis dependency create a strong economic justification for adoption, particularly in academic medical centers where complex pediatric cases are concentrated.

DENVER, Jan. 08, 2025 (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 the shipment of its QUELIMMUNE^™ device to a prominent academic medical center, representing SeaStar Medical’s fourth commercial customer. QUELIMMUNE is the company’s Selective Cytopheretic Device (SCD) for treating critically ill children in the intensive care unit (ICU) with acute kidney injury (AKI) and sepsis.

“We are pleased to expand commercial access to QUELIMMUNE and are extremely proud to be the only company to develop and commercialize a therapeutic device that has demonstrated clinical results to reduce mortality and decrease dialysis dependency in these severely ill children,” said Tim Varacek, SeaStar Medical Senior Vice President, Commercial & Business Operations.

“In addition to compelling clinical benefits, QUELIMMUNE’s ability to reduce healthcare costs is another reason for hospitals to adopt our therapeutic device,” said Eric Schlorff, SeaStar Medical CEO. “Our data show that AKI patients treated with the SCD had no dialysis dependency 60 days after treatment. Because the cost for a single patient on dialysis is about $100,000 per year, eliminating this cost represents a substantial and ongoing savings to the healthcare system. QUELIMMUNE also has the potential to reduce the average length of hospital stay and to lower the rate of readmissions and post-acute emergency visits. Of note, the average hospital cost per pediatric ICU patient with AKI including those with sepsis requiring continuous renal replacement therapy exceeds $350,000.”

QUELIMMUNE is being commercialized following U.S. Food and Drug Administration (FDA) approval for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with renal replacement therapy (RRT). QUELIMMUNE was approved under a Humanitarian Device Exemption (HDE) application, having met the applicable criteria with clinical results showing safety and probable clinical benefit in a limited population of critically ill children with AKI who have few treatment options.

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 complications including chronic kidney disease or end-stage renal disease requiring dialysis. Hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.

Selective Cytopheretic Device

The Selective Cytopheretic Device (SCD) is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT) and reduces the hyperinflammatory milieu including the cytokine storm. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CRRT 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 renal replacement therapy (RRT), including dialysis.

The SCD has been awarded FDA Breakthrough Device Designation in four indications:

• Cardiorenal Syndrome with Left Ventricular Assist Device
• Adult Acute Kidney Injury
• Hepatorenal Syndrome
• Chronic Dialysis

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 1995. These forward-looking statements include, without limitation, the ability of the SCD to treat patients with AKI and other diseases; and anticipated cost savings for patients, healthcare providers, and the healthcare system more generally from the adoption of the SCD. 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:

Alliance Advisors IR
Jody Cain
(310) 691-7100
Jcain@allianceadvisors.com

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FAQ

What are the cost savings associated with SeaStar Medical's QUELIMMUNE device (ICU)?

QUELIMMUNE can save approximately $100,000 per patient annually by eliminating dialysis dependency, with additional potential savings from reduced hospital stays and lower readmission rates.

What are the FDA-approved uses for SeaStar Medical's QUELIMMUNE (ICU)?

QUELIMMUNE is FDA-approved under Humanitarian Device Exemption for treating children weighing 10kg or more with acute kidney injury and sepsis who are in ICU requiring renal replacement therapy.

How many hospitals are now using SeaStar Medical's QUELIMMUNE device (ICU)?

As of January 2024, SeaStar Medical has shipped QUELIMMUNE to four hospital customers, with the latest being a prominent academic medical center.

What clinical benefits does SeaStar Medical's QUELIMMUNE (ICU) demonstrate?

QUELIMMUNE has demonstrated clinical results in reducing mortality and decreasing dialysis dependency in critically ill children, with data showing no dialysis dependency 60 days after treatment.

What breakthrough designations has SeaStar Medical's SCD technology (ICU) received?

The SCD has received FDA Breakthrough Device Designation in four indications: Cardiorenal Syndrome with Left Ventricular Assist Device, Adult Acute Kidney Injury, Hepatorenal Syndrome, and Chronic Dialysis.