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SeaStar Medical Finalizes FDA Labeling Requirement for QUELIMMUNE, Paving the Way for First Commercial Sales as Humanitarian Use Device

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SeaStar Medical (Nasdaq: ICU) has finalized FDA labeling for QUELIMMUNE™, a device aimed at reducing hyperinflammation in pediatric patients with acute kidney injury (AKI) and sepsis or septic conditions requiring kidney replacement therapy (KRT). This approval under the Humanitarian Use Device (HUD) designation allows SeaStar to market QUELIMMUNE in the U.S. for children weighing 10 kilograms or more. Clinical results showed a 77% survival rate, with no dialysis dependency at 60 days and no device-related serious adverse events. The device is expected to be available for shipment this month, addressing a U.S. market of approximately 4,000 children annually.

Positive
  • FDA final labeling approval for QUELIMMUNE paves the way for U.S. market launch under HUD designation.
  • QUELIMMUNE showed a 77% survival rate in clinical studies for pediatric patients with AKI requiring KRT.
  • The device is set to address a market of approximately 4,000 children annually in the U.S.
  • No device-related serious adverse events or infections were reported in studies.
Negative
  • market size for the pediatric application of QUELIMMUNE, with only about 4,000 eligible children annually.

QUELIMMUNE’s final FDA labeling approval represents a significant milestone for SeaStar Medical and a lifeline for pediatric patients with acute kidney injury (AKI) and sepsis. The Humanitarian Use Device (HUD) designation allows the device to be marketed specifically for children, where treatment options are scarce. One key insight from the pooled analysis showed a 77% survival rate for treated children, which is promising compared to the current survival rate of around 50%. This marked improvement could not only impact treatment standards but also set new benchmarks in pediatric care. However, the small addressable market of roughly 4,000 children annually under HDE criteria means that the immediate financial impact may be limited. Despite this, the medical community could see QUELIMMUNE as a pioneering device, which could drive future innovations and expansions.

The approval for QUELIMMUNE marks SeaStar Medical's first major step into commercializing a product with significant clinical and market potential. Although the pediatric market is relatively small, this approval provides a gateway to a much larger adult market, estimated to be around 210,000 patients per year. This is about 50 times larger than the pediatric market. The ability to demonstrate success in a smaller, high-need market can provide the company with the clinical credibility and market validation required to drive forward their pivotal trials in adults. Investors should note that while the immediate revenue may not skyrocket, the strategic positioning and first-mover advantage in this niche market could bode well for long-term growth and expansion into broader markets.

From a financial perspective, the FDA’s approval for QUELIMMUNE under the HUD designation could offer SeaStar Medical a competitive edge in an untapped market. With the device requiring daily replacement and an average seven-day therapy per patient, there is a potential for recurring revenue streams. Although the pediatric market size is limited to about 4,000 children annually, the subsequent focus on the adult population, which is significantly larger, could exponentially increase revenue if future trials succeed. Additionally, obtaining FDA approval often leads to increased investor confidence and can potentially drive up the company’s stock price. However, the company must carefully manage manufacturing and distribution logistics, especially for a product that undergoes daily changes. Investors should closely monitor the initial sales figures and feedback from medical institutions to gauge the device’s real-world efficacy and market reception.

DENVER, July 03, 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 the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has agreed to the final labeling for SeaStar Medical’s QUELIMMUNE, the Selective Cytopheretic Device for pediatric patients, paving the way under the Humanitarian Use Device (HUD) designation to market the therapeutic device in the U.S. for the treatment of children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or septic condition requiring kidney replacement therapy (KRT).

“We thank the FDA for diligently working through QUELIMMUNE’s labeling. We are now ready to make final changes to product labels for incorporation into the commercial kits,” said Eric Schlorff, SeaStar Medical CEO. “We expect to begin shipping this month and are excited to bring the potential lifesaving and quality-of-life benefits of QUELIMMUNE to critically ill children.”

Pediatric Acute Kidney Injury
QUELIMMUNE is approved under a Humanitarian Device Exemption (HDE) application, having met the applicable criteria with clinical results showing safety and probable clinical benefit to critically ill children with AKI who have few treatment options. Pediatric patients undergoing treatment with QUELIMMUNE are expected to require, on average, seven QUELIMMUNE daily therapies, with the disposable device being changed once every 24 hours.

Only about half of patients in the pediatric ICU with AKI who require KRT survive, with those surviving being at risk of long-term, life-threatening conditions such as chronic kidney disease. A pooled analysis from two non-controlled studies (one of which was funded by the FDA Office of Orphan Products Development) showed that children weighing 10 kilograms or more with AKI requiring continuous KRT who were treated with QUELIMMUNE had a 77% survival rate, no dialysis dependency at day 60 and no device-related serious adverse events or device-related infections. The U.S. addressable population of about 4,000 children falls within the 8,000-patient HDE criteria.

SeaStar Medical is also conducting a pivotal trial in adults with AKI who require continuous KRT. The applicable adult population is approximately 210,000 patients per year, or about 50 times larger than the pediatric population.

About the Selective Cytopheretic Device (SCD)
The SCD is a patented, cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous KRT and reduces the hyperinflammatory milieu including the cytokine storm that causes inflammation, organ failure, and possible death in critically ill patients. Unlike pathogen removal and other blood-purification tools, the device is integrated with KRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. The SCD selectively targets the most highly activated proinflammatory neutrophils and monocytes. These cells are then returned back into the body through the blood, and the body is signaled to lower its inflammatory environment and focus on repair. This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future KRT, including 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 1955. These forward-looking statements include, without limitation, SeaStar Medical’s expectations with respect to the ability of SCD to treat patients with AKI and other diseases; 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 do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.

Investor Contact:
LHA Investor Relations 
Jody Cain 
(310) 691-7100 
Jcain@lhai.com

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FAQ

What is QUELIMMUNE?

QUELIMMUNE is a Selective Cytopheretic Device developed by SeaStar Medical to treat pediatric patients with acute kidney injury (AKI) and sepsis or septic conditions requiring kidney replacement therapy (KRT).

When was QUELIMMUNE approved by the FDA?

QUELIMMUNE received final FDA labeling approval on July 3, 2024.

What is the survival rate for children treated with QUELIMMUNE?

Clinical studies have shown a 77% survival rate for children treated with QUELIMMUNE.

What is the market potential for QUELIMMUNE in the U.S.?

QUELIMMUNE is expected to address a market of approximately 4,000 pediatric patients annually in the U.S.

Are there any serious adverse events related to QUELIMMUNE?

No device-related serious adverse events or infections were reported in the clinical studies for QUELIMMUNE.

What is SeaStar Medical's stock symbol?

SeaStar Medical's stock symbol is ICU.

When will QUELIMMUNE be available for commercial sales?

SeaStar Medical expects to begin shipping QUELIMMUNE later this month.

SeaStar Medical Holding Corporation

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