DENVER, July 23, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical) reports treatment of the first patient in a commercial setting with QUELIMMUNE™, its U.S. Food and Drug Administration (FDA)-approved, patented cell-directed extracorporeal therapy to treat acute kidney injury (AKI) in pediatric patients weighing 10 kilograms or greater with sepsis or a septic condition requiring kidney replacement therapy (KRT). With this development, the Company has now met the August 20, 2024 FDA deadline to begin patient treatments, which is designated in the FDA’s approval of QUELIMMUNE.
“This commercial milestone is highly gratifying to the SeaStar Medical team that has worked so hard to make QUELIMMUNE available to patients in need. Results from completed clinical trials show the potential of QUELIMMUNE to save the lives and decrease dialysis dependency of these severely ill children with AKI, and we are dedicated to ensuring widespread access to our therapeutic device,” said Eric Schlorff, CEO of SeaStar Medical. “We have now met the FDA’s requirement for a timely first treatment.”
Each year in the U.S., approximately 4,000 children with AKI require continuous KRT, with a mortality rate of approximately 50%. Many of those who survive experience long-term complications that can include chronic kidney disease and a lifetime of dialysis. Pooled analysis from two non-controlled clinical studies, one of which was funded by the FDA office of Orphan Products Development, showed that children with AKI weighing 10 kilograms or more requiring continuous KRT treated with QUELIMMUNE had a 77% survival rate with no dialysis dependency at 60 days, and had no device-related serious adverse events or device-related infections.
About Acute Kidney Disease (AKI)
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. In critically ill patients with AKI, a dysregulated immune response can lead to hyperinflammation, which may contribute to significant morbidity, including prolonged ICU stays, increased reliance on dialysis and mechanical ventilation, and higher hospital costs. Damage resulting from this dysregulated response in AKI can progress to other organs, such as the heart or liver. Multi-organ dysfunction or even failure can lead to 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.
About QUELIMMUNE
QUELIMMUNE is SeaStar Medical’s first Selective Cytopheretic Device (SCD) to receive FDA approval. This therapeutic device selectively targets the most highly activated proinflammatory neutrophils and monocytes and restores them to a reparative state. QUELIMMUNE consists of a SCD pediatric (SCD-PED) cartridge and blood tubing set that are connected in-line to an existing hemodialysis delivery system’s extracorporeal continuous KRT circuit in a process that takes about 15 minutes. The Company expects that, on average, a full course of treatment for children with AKI will require three to seven days of treatment, with the disposable SCD-PED cartridge being replaced every 24 hours.
SeaStar Medical is actively enrolling patients in the adult NEUTRALIZE-AKI pivotal clinical trial. The adult AKI population is 50 times larger than the pediatric population, which the Company believes represents a multibillion-dollar market opportunity. The SCD is a platform technology with potential in multiple disease conditions affected by hyperinflammation.
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 amount and timing of future QUELIMMUNE commercial sales; commercial acceptance of QUELIMMUNE; 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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