SeaStar Medical Expands NEUTRALIZE-AKI Pivotal Trial Adding Two Premier Military Medical Facilities

Rhea-AI Summary

SeaStar Medical Holding (Nasdaq: ICU) announces the expansion of its NEUTRALIZE-AKI pivotal trial with the addition of two premier military medical facilities: Brooke Army Medical Center (BAMC) and the United States Army Institute of Surgical Research (USAISR). This brings the total number of active clinical sites to 11, with 48 subjects enrolled to date. The trial is evaluating the safety and efficacy of SeaStar Medical's Selective Cytopheretic Device (SCD) in treating acute kidney injury (AKI) in adult ICU patients receiving continuous kidney replacement therapy (CKRT).

The SCD has received FDA Breakthrough Device Designation for adults with AKI. In July 2024, CMS granted Category B coverage for certain expenses related to the trial. SeaStar Medical also began shipping its pediatric SCD, branded QUELIMMUNE™, in July 2024 following FDA approval. The company paid off all interest-bearing debt in September 2024.

Positive

• Expansion of NEUTRALIZE-AKI pivotal trial to 11 active clinical sites
• 48 subjects enrolled to date in the trial
• FDA Breakthrough Device Designation received for SCD in adult AKI
• CMS granted Category B coverage for certain trial expenses
• Commercialization of QUELIMMUNE™ for pediatric AKI patients began in July 2024
• All interest-bearing debt paid off in September 2024

Negative

• None.

Insights

Medical Research Analyst

The expansion of SeaStar Medical's NEUTRALIZE-AKI pivotal trial to include two premier military medical facilities is a significant development. This broadens the trial's scope and potential impact, now encompassing 11 active clinical sites with 48 subjects enrolled. The Selective Cytopheretic Device (SCD) being evaluated has already received FDA Breakthrough Device Designation for adults with AKI, indicating its potential to address a serious medical need.

Key points to consider:

• The inclusion of military facilities may provide insights into treating AKI in trauma and combat-related cases.
• The trial's primary endpoint of 90-day mortality or dialysis dependency is a robust measure of the SCD's efficacy.
• Secondary endpoints, including 28-day mortality and long-term dialysis dependency, will offer a comprehensive view of the device's impact.
• The subgroup analyses for AKI patients with sepsis and ARDS could open additional treatment pathways.

While the trial's progress is promising, investors should note that pivotal trials are complex and outcomes are never guaranteed. The potential market for AKI treatment is substantial, given its prevalence and serious consequences, which could translate to significant revenue if the SCD proves effective and gains widespread adoption.

Financial Analyst

SeaStar Medical's recent developments present a positive outlook for investors. The expansion of the NEUTRALIZE-AKI trial to military facilities not only broadens the study's scope but also potentially opens doors to lucrative government contracts if successful. The FDA Breakthrough Device Designation and CMS Category B coverage for the trial expenses are significant regulatory achievements that could accelerate market entry and reimbursement.

Key financial considerations:

• The company has already begun commercializing QUELIMMUNE™ for pediatric AKI, providing an immediate revenue stream.
• The pay-off of all interest-bearing debt in September 2024 strengthens the company's balance sheet.
• The potential market for AKI treatment is substantial, with opportunities in both adult and pediatric segments.
• If successful, the SCD could reduce healthcare costs associated with prolonged ICU stays and dialysis dependence, making it attractive to healthcare providers and insurers.

While the company's $17 million market cap suggests it's still in early stages, successful trial outcomes could lead to significant value creation. Investors should monitor enrollment progress, interim results and any regulatory updates closely.

DENVER , Oct. 08, 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 activation of Brooke Army Medical Center (BAMC) and the United States Army Institute of Surgical Research (USAISR), expanding the number of sites in its NEUTRALIZE-AKI pivotal trial. This trial is evaluating the safety and efficacy of SeaStar Medical’s innovative Selective Cytopheretic Device (SCD) in treating acute kidney injury (AKI) in adult ICU patients receiving continuous kidney replacement therapy (CKRT). With the inclusion of these prestigious military medical facilities, SeaStar Medical now has 11 active clinical sites with 48 subjects enrolled to date.

The SCD has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for adults with AKI, which is awarded to the SCD as 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 U.S. Centers for Medicare and Medicaid (CMS) granted Category B coverage for certain expenses incurred by medical centers treating Medicare and Medicaid patients enrolled in the NEUTRALIZE-AKI pivotal trial.

“We are delighted that these premier Department of Defense (DoD) facilities have joined our adult AKI trial,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “BAMC and USAISR are where the most critically ill patients from the DoD and the south Texas region are treated. Having these two sites on board will help us achieve our goal of making this disease-modifying therapy available for all critically ill patients with AKI, regardless of the type of hospital.”

Among other accomplishments, SeaStar Medical began shipping the SCD Pediatric, brand named QUELIMMUNE^™, for pediatric patients with AKI and sepsis indications in July 2024, having received Humanitarian Device Exemption (HDE) approval from the FDA earlier in 2024. Additionally, the Company paid-off all interest-bearing debt in September 2024.

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, SeaStar Medical’s expectations with respect to anticipated patient enrollment and the expansion of the clinical trial sites; 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.

Contact: 

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

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FAQ

What is the NEUTRALIZE-AKI pivotal trial testing?

The NEUTRALIZE-AKI pivotal trial is evaluating the safety and efficacy of SeaStar Medical's Selective Cytopheretic Device (SCD) in treating acute kidney injury (AKI) in adult ICU patients receiving continuous kidney replacement therapy (CKRT).

How many clinical sites are now active in SeaStar Medical's NEUTRALIZE-AKI trial?

SeaStar Medical (Nasdaq: ICU) now has 11 active clinical sites in its NEUTRALIZE-AKI pivotal trial, including the recently added Brooke Army Medical Center and the United States Army Institute of Surgical Research.

What regulatory designations has SeaStar Medical's SCD received?

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

When did SeaStar Medical begin commercializing QUELIMMUNE™?

SeaStar Medical began shipping QUELIMMUNE™, the SCD Pediatric device, in July 2024 following FDA approval for children with AKI and sepsis or septic condition weighing 10 kilograms or more.