SeaStar Medical Reports Enrollment Momentum in Its Pivotal Adult AKI Trial

Rhea-AI Summary

SeaStar Medical Holding (Nasdaq: ICU) reports progress in its pivotal NEUTRALIZE-AKI trial, with four new subjects enrolled in 10 days, bringing total enrollment to 46. The trial evaluates the company's Selective Cytopheretic Device (SCD) for adults with acute kidney injury (AKI) in ICU receiving continuous kidney replacement therapy (CKRT).

Key points:

• Trial aims to enroll up to 200 adults
• Primary endpoint: 90-day mortality or dialysis dependency
• Interim analysis planned at halfway point
• Company plans to expand trial sites to accelerate enrollment

The SCD is designed to reduce hyperinflammation in AKI patients, potentially improving outcomes and reducing healthcare costs. SeaStar Medical's pediatric version, QUELIMMUNE™, received FDA approval in February 2024 for children with AKI and sepsis.

Positive

• Enrollment momentum in NEUTRALIZE-AKI trial with 4 new subjects in 10 days
• Total trial enrollment reached 46 subjects
• Plans to expand trial sites by more than a dozen to accelerate enrollment
• Potential for early trial conclusion if statistical significance is reached at interim analysis
• FDA approval of QUELIMMUNE™ for pediatric use in February 2024

Negative

• Slow enrollment during summer period due to low ICU census
• Trial still far from original goal of 200 subjects

Insights

Medical Research Analyst

The enrollment of 4 additional subjects in SeaStar Medical's NEUTRALIZE-AKI trial marks significant progress in evaluating the Selective Cytopheretic Device (SCD) for acute kidney injury (AKI). With 46 subjects now enrolled, the trial is approaching its halfway point, where an interim analysis could potentially lead to early conclusion if statistical significance is reached.

Key points to consider:

• The trial aims to enroll up to 200 adults, focusing on 90-day mortality or dialysis dependency as primary endpoints.
• SeaStar plans to expand trial sites by more than a dozen to accelerate enrollment.
• The SCD's unique approach targets proinflammatory cells during continuous kidney replacement therapy, potentially reducing hyperinflammation and promoting organ recovery.
• If successful, this could represent a significant advancement in AKI treatment, potentially reducing healthcare costs associated with prolonged ICU stays and dialysis dependence.

While the recent enrollment uptick is promising, investors should note that trial completion and potential FDA approval for adult use are still some way off. The pediatric version (QUELIMMUNE™) has already received FDA approval under an HDE, which could provide some revenue in the interim.

DENVER, Sept. 25, 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 the enrollment of four additional subjects in a 10-day period in its pivotal NEUTRALIZE-AKI trial, bringing total trial enrollment to 46. This trial is evaluating the safety and efficacy of SeaStar Medical’s proprietary therapeutic Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) in the intensive care unit (ICU) receiving continuous kidney replacement therapy (CKRT).

“We are encouraged to see a recent uptick in enrollment following a slow summer period due to low census across many of the ICUs participating in this trial,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “Finishing this pivotal trial is a major priority for our company and will bring us one step closer to commercialization of what we believe is a practice-changing therapy in critically ill adults. Our next major step is an interim analysis at the halfway point, which will help inform our Data and Safety Monitoring Board (DSMB) that can recommend concluding the study early if statistical significance is reached. Regardless, we are working to expand the number of trial sites by more than a dozen to accelerate towards our original goal of enrolling 200 subjects as quickly as possible.”

NEUTRALIZE-AKI Pivotal Trial

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 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.

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.

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. 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.

The SCD-Pediatric device, brand named QUELIMMUNE^™, is being commercialized following earning FDA approval for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with KRT. QUELIMMUNE was approved in February 2024 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.

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 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
Jcain@lhai.com

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FAQ

What is the current enrollment status of SeaStar Medical's NEUTRALIZE-AKI trial for ICU stock?

SeaStar Medical (Nasdaq: ICU) has enrolled 46 subjects in its NEUTRALIZE-AKI trial, with 4 new subjects added in a recent 10-day period.

How many subjects is the NEUTRALIZE-AKI trial aiming to enroll for ICU stock?

The NEUTRALIZE-AKI trial for SeaStar Medical (Nasdaq: ICU) is expected to enroll up to 200 adults.

What is the primary endpoint of SeaStar Medical's NEUTRALIZE-AKI trial for ICU stock?

The primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD in addition to CKRT, compared to the control group receiving only CKRT.

When did SeaStar Medical receive FDA approval for QUELIMMUNE for ICU stock?

SeaStar Medical (Nasdaq: ICU) received FDA approval for QUELIMMUNE, the pediatric version of SCD, in February 2024 under a Humanitarian Device Exemption.