SeaStar Medical Announces that Enrollment in its Adult Acute Kidney Injury Pivotal Trial Has Exceeded the Halfway Point Toward an Interim Analysis

Rhea-AI Summary

SeaStar Medical Holding (Nasdaq: ICU) announces that its NEUTRALIZE-AKI pivotal trial has enrolled 51 subjects, surpassing the halfway point towards the 100-subject target for an interim analysis. The trial evaluates the safety and efficacy of SeaStar's Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) in ICU receiving continuous kidney replacement therapy (CKRT).

Key points:

• Enrollment pace has accelerated since summer, with 5 subjects enrolled in October
• SCD received FDA Breakthrough Device Designation for adults with AKI
• Centers for Medicare & Medicaid Services granted Category B coverage for certain expenses in July 2024
• SeaStar began shipping SCD Pediatric (QUELIMMUNE™) in July 2024
• The company extinguished all interest-bearing debt in September 2024

The NEUTRALIZE-AKI trial aims to enroll up to 200 adults at up to 30 clinical sites, with a primary endpoint of 90-day mortality or dialysis dependency.

Positive

• Enrollment in NEUTRALIZE-AKI pivotal trial has exceeded 50% of target for interim analysis
• Accelerated enrollment pace with 5 subjects enrolled in October 2024
• FDA Breakthrough Device Designation received for SCD in adults with AKI
• Category B coverage granted by CMS for certain trial expenses
• Commenced shipping of SCD Pediatric (QUELIMMUNE™) for pediatric AKI and sepsis patients
• Extinguishment of all interest-bearing debt in September 2024

Negative

• Experienced a slowdown in enrollment during summer months

Insights

Medical Research Analyst

The NEUTRALIZE-AKI pivotal trial for SeaStar Medical's Selective Cytopheretic Device (SCD) has reached a significant milestone with 51 subjects enrolled, surpassing the halfway point towards the 100-subject target for interim analysis. This acceleration in enrollment, particularly after a summer slowdown, is a positive indicator for the trial's progress.

The SCD, which has received FDA Breakthrough Device Designation for adults with Acute Kidney Injury (AKI), aims to address a critical medical need. AKI is a serious condition that can lead to hyperinflammation and multi-organ dysfunction. The device's unique approach of targeting proinflammatory neutrophils and monocytes during continuous kidney replacement therapy (CKRT) could potentially improve outcomes for ICU patients with AKI.

The trial's primary endpoint, focusing on 90-day mortality or dialysis dependency, will provide important data on the SCD's efficacy. If successful, this could represent a significant advancement in AKI treatment, potentially reducing healthcare costs associated with prolonged ICU stays and long-term dialysis requirements.

Financial Analyst

SeaStar Medical's progress in the NEUTRALIZE-AKI trial is a positive development for the company's financial outlook. The accelerated enrollment rate suggests potential for earlier trial completion and, if successful, faster time-to-market for the SCD in adult AKI patients.

The company has already begun commercializing QUELIMMUNE™, the pediatric version of SCD, following FDA approval under a Humanitarian Device Exemption. This dual-track approach - commercializing the pediatric device while advancing the adult trial - diversifies revenue potential and mitigates risk.

Notably, SeaStar Medical has extinguished all interest-bearing debt as of September 2024, improving its financial position. The Category B coverage granted by CMS for certain trial expenses could also help manage costs associated with the NEUTRALIZE-AKI study.

While the company's market cap of $17,060,557 suggests it's still in a growth phase, successful trial outcomes and potential FDA approval for the adult SCD could significantly impact valuation and attract investor interest in the medical device sector.

The pace of patient enrollment has significantly accelerated following a summertime slowdown

DENVER, Oct. 18, 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 51 subjects have been enrolled in its NEUTRALIZE-AKI pivotal trial, passing the halfway point toward the target of 100 subjects for performing an interim analysis on the trial’s 90-day primary endpoint. The 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).

“The pace of enrollment in NEUTRALIZE-AKI has significantly accelerated from the summer lows, with the recent momentum driving us past the halfway point toward the planned interim analysis,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “We have enrolled five subjects already in October, after enrolling only three in July and three in August. This current pace is encouraging as we work to activate additional clinical trial sites.”

SeaStar Medical’s SCD previously received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for adults with AKI, which is awarded to a therapy to treat a serious or life-threatening condition with preliminary clinical evidence indicating it may demonstrate substantial improvement over available therapies on clinically significant endpoints. In July 2024, the Centers for Medicare & Medicaid Services granted Category B coverage for certain expenses incurred by medical centers when treating Medicare or Medicaid patients enrolled in NEUTRALIZE-AKI.

In July 2024 SeaStar Medical began shipping the SCD Pediatric, brand named QUELIMMUNE^™, for pediatric patients with AKI and sepsis indications, having received Humanitarian Device Exemption (HDE) approval from the FDA earlier in the year. Also, in September 2024 the Company announced the extinguishment of all interest-bearing debt.

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 at up to 30 clinical sites. 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 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?

SeaStar Medical's NEUTRALIZE-AKI trial has enrolled 51 subjects, surpassing the halfway point towards the 100-subject target required for an interim analysis.

When did SeaStar Medical (ICU) begin shipping its SCD Pediatric device?

SeaStar Medical began shipping the SCD Pediatric device, branded as QUELIMMUNE™, in July 2024 for pediatric patients with AKI and sepsis indications.

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

The primary endpoint of the NEUTRALIZE-AKI trial is a composite of 90-day mortality or dialysis dependency in patients treated with SCD plus CKRT compared to those receiving only CKRT as standard care.

Has SeaStar Medical's (ICU) Selective Cytopheretic Device received any FDA designations?

Yes, SeaStar Medical's Selective Cytopheretic Device (SCD) has received FDA Breakthrough Device Designation for adults with acute kidney injury (AKI).