SeaStar Medical Provides Updates on Enrollment of Adult Pivotal Clinical Study and Commercial Launch of Quelimmune, FDA-Approved in Pediatric Patients
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Insights
The NEUTRALIZE-AKI pivotal clinical trial conducted by SeaStar Medical is a critical step in the development of the Selective Cytopheretic Device (SCD) for treating acute kidney injury (AKI). The enrollment of 21 subjects and the expansion to additional clinical sites indicate progress in a trial that could have significant implications for the treatment of AKI in critically ill patients. The trial's design, focusing on a composite primary endpoint of 90-day mortality or dialysis dependency, is structured to provide a robust measure of the SCD's effectiveness when used in conjunction with continuous kidney replacement therapy (CKRT).
Secondary endpoints, including 28-day mortality and ICU-free days, offer additional dimensions to evaluate the SCD's impact on patient outcomes. The subgroup analyses for patients with sepsis and acute respiratory distress syndrome could provide insights into the device's efficacy across different patient populations. The potential reduction in dialysis dependency, especially with a reported 77% survival rate in pediatric trials, is noteworthy given the high costs associated with chronic kidney disease resulting from AKI.
The FDA's Humanitarian Device Exemption (HDE) Approval Order for the Quelimmune™ pediatric device is a strategic milestone for SeaStar Medical. HDE approval suggests a recognition of the device's potential to address unmet medical needs in pediatric AKI treatment. The partnership with Nuwellis, Inc. for commercial rollout could be a catalyst for revenue growth, especially as the company targets key hospitals and navigates the institutional review board approval process.
Investors should note the cost-saving implications of reducing dialysis dependency in AKI patients. Given the high costs of dialysis for patients developing chronic kidney disease from AKI, the successful adoption of SeaStar's SCD could result in significant healthcare savings. This factor, combined with the ongoing pivotal trial, may influence the company's valuation and stock performance, particularly if the interim analysis in the second half of 2024 yields positive results.
The necessity for institutional review board approval for hospital purchases of the Quelimmune™ device under the HDE reflects the regulatory environment's emphasis on safety and efficacy in pediatric patient populations. The HDE pathway, while facilitating the availability of medical devices for small patient populations, requires careful consideration of the device's risk-benefit profile. SeaStar Medical's engagement with key hospitals and its commercial strategy must align with these regulatory nuances to ensure successful market penetration and adoption of their SCD technology.
Furthermore, the potential healthcare system benefits highlighted by the company, such as reduced dialysis costs, align with broader policy goals of improving patient outcomes while managing healthcare expenditures. The company's ability to demonstrate these benefits in real-world settings will be crucial for gaining support from healthcare providers and payers.
Company plans to hold a business update conference call in April
DENVER, March 12, 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, provides updates on the acute kidney injury (AKI) programs it is developing with its patented, first-to-market, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill patients with AKI.
“We now have 21 subjects enrolled across five clinical sites in our NEUTRALIZE-AKI pivotal clinical trial, which is intended to evaluate the safety and efficacy of our SCD in adult AKI patients. Additional sites are progressing through the site activation and contract completion process,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “We expect the pace of enrollment will accelerate as more medical centers come onboard. We anticipate conducting an interim analysis once we have reached our 90-day primary endpoint in 100 enrolled subjects, which we expect to reach in the second half of 2024.”
The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomiZEd clinical trial in Acute Kidney Injury) pivotal trial is expected to enroll up to 200 adults. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD in addition to continuous kidney replacement therapy (CKRT) as the standard of care, compared with the control group receiving only CKRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. More information on the trial is available here.
In February 2024 the U.S. Food and Drug Administration (FDA) granted a Humanitarian Device Exemption (HDE) Approval Order to the Quelimmune™ pediatric device for use in children weighing 10 kilograms or more with AKI due to sepsis or a septic condition requiring kidney replacement therapy (KRT).
“Interactions with several key target hospitals are underway with plans to expand the commercial rollout with Nuwellis, Inc. during the second quarter,” said Eric Schlorff, CEO of SeaStar Medical. “As our therapeutic device is approved under an HDE, each hospital is required to secure institutional review board approval prior to purchasing the device for use in patients. We view Quelimmune as a tremendous win for children with AKI requiring CKRT given clinical results from our AKI pediatric trials that showed a
SeaStar Medical estimates the eligible population for its Quelimmune pediatric device to be approximately 4,000 children annually with AKI. About
The FDA’s HDE Approval Order was based on a pooled analysis from two non-controlled studies, SCD-PED-01 (funded by the FDA Office of Orphan Products Development) and SCD-PED-02. These studies showed that pediatric patients weighing ≥10kg with AKI requiring CKRT treated with the Quelimmune pediatric device had no device-related serious adverse events or device-related infections, a
SeaStar Medical also announces that its executive management team plans to hold a business update conference call in April to discuss progress with its AKI programs and opportunities in other indications, and to answer questions. Details regarding this call will be made available in the coming weeks.
About Hyperinflammation
Hyperinflammation is the overproduction or overactivity of inflammatory cells that can lead to damage of vital organs. It occurs when the body overproduces inflammatory effector cells and other molecules that can be toxic, damaging to vital organs and result in multi-organ failure and even death. This is known as the cytokine storm.
About The 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 CKRT 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 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. 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. Quelimmune is the official brand name for the Selective Cytopheretic Device in pediatrics that has received FDA HDE Approval based on safety and probable efficacy.
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 SCD’s ability to treat hyperinflammation and the expected results of clinical trials and studies. 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 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, including the equity line of credit and forward purchase 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 assume 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.
Contact:
LHA Investor Relations
Jody Cain
(310) 691-7100
Jcain@lhai.com
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