SeaStar Medical Activates Sentara Norfolk General Hospital and Provides Enrollment Update in Adult AKI Pivotal Trial

Rhea-AI Summary

SeaStar Medical (Nasdaq: ICU) announces the activation of its thirteenth site, Sentara Norfolk General Hospital, in the NEUTRALIZE-AKI pivotal trial. The trial enrolled nine new patients in November, reaching 65 total subjects. The study aims to evaluate the safety and efficacy of the company's Selective Cytopheretic Device (SCD) in 200 adult patients with acute kidney injury (AKI) in ICU receiving continuous renal replacement therapy.

Enrollment rate has doubled in Q4's first two months compared to previous quarters. The company estimates annual peak sales of approximately $1 billion for SCD in the AKI indication, which affects about 210,000 U.S. patients annually. The trial's primary endpoint focuses on 90-day mortality or dialysis dependency comparing SCD+CRRT versus CRRT alone.

Positive

• Enrollment rate doubled in Q4 compared to previous quarters
• Estimated annual peak sales of $1B for AKI indication
• FDA Breakthrough Device Designation obtained for adult AKI
• Medicare/Medicaid Category B coverage granted for trial expenses
• 13 active trial sites with continued expansion

Negative

• Trial still requires 135 more patients to reach 200-patient enrollment target

Insights

Medical Research Analyst

<p>The NEUTRALIZE-AKI trial update shows significant progress with <b>65 patients enrolled</b> and <b>13 active sites</b>, including nine new enrollments in November alone. The trial's acceleration is notable, with Q4 enrollment nearly doubling previous quarters. The SCD device targets a substantial market opportunity of <b>210,000 annual U.S. patients</b> with projected peak sales of <money>$1 billion</money>.</p><p>The trial's robust design, measuring both 90-day mortality and dialysis dependency, alongside the FDA Breakthrough Device Designation and CMS Category B coverage, strengthens the potential for successful commercialization. The technology's unique immunomodulation approach and multiple breakthrough designations across different indications suggest broader therapeutic applications beyond AKI.</p>

Financial Analyst

<p>The accelerating trial enrollment and expanded site activation signal improved execution efficiency, potentially reducing time to market. The <money>$1 billion</money> peak sales projection for adult AKI alone represents significant revenue potential for a company with a <money>$10.4 million</money> market cap. The recent pediatric FDA approval of QUELIMMUNE™ and multiple breakthrough designations create a diversified product pipeline.</p><p>The CMS Category B coverage designation is particularly valuable, as it helps reduce trial costs and paves the way for future reimbursement. This combination of clinical progress, regulatory advantages and market opportunity suggests substantial upside potential despite current market valuation.</p>

DENVER, Dec. 03, 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 Sentara Norfolk General Hospital in Norfolk, Virginia as its thirteenth active site in its NEUTRALIZE-AKI pivotal trial. The Company also reports the enrollment of nine critically ill adult acute kidney injury (AKI) patients in the trial during November, bringing total trial enrollment to 65 subjects. The NEUTRALIZE-AKI trial is evaluating the safety and efficacy of the Company’s proprietary therapeutic Selective Cytopheretic Device (SCD) in 200 adult patients with AKI in the intensive care unit (ICU) receiving continuous renal replacement therapy (CRRT).

“We are thankful for the steady pace of site activations and continued brisk enrollment with our recently activated sites already contributing,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “The rate of enrollment has increased significantly with nearly two times the number of subjects enrolled in the first two months of the fourth quarter, compared with the total number for each of the previous three quarters of 2024. We are working to activate additional sites in December, which will help us reach our enrollment milestones sooner.”

“Previously completed pilot studies demonstrate the SCD’s ability to save the lives of critically ill patients with AKI and to eliminate dialysis dependence, with additional benefits to the overall healthcare system,” said Eric Schlorff, SeaStar Medical CEO. “Given the addressable adult AKI population of approximately 210,000 patients in the U.S. each year, we estimate annual peak sales of approximately $1 billion for the SCD in this indication. AKI is only one of multiple high-value indications where hyperinflammation plays a role and we have preliminary evidence of effectiveness of the SCD in mitigating a variety of illnesses. We plan to pursue cardiorenal syndrome as our next clinical focus.”

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.

NEUTRALIZE-AKI Pivotal Trial

The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) is expected to enroll up to 200 adults. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency among patients treated with SCD in addition to CRRT as the standard of care, compared with the control group receiving only CRRT 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 complications including chronic kidney disease or end-stage renal disease requiring dialysis. 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 CRRT and reduces the hyperinflammatory milieu including the cytokine storm. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CRRT 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 renal replacement treatment (RRT), including dialysis.

The SCD has been awarded FDA Breakthrough Device Designation in four indications:

• Cardiorenal Syndrome – Left Ventricular Assist Device (CRS-LVAD)
• Adult Acute Kidney Injury (AKI)
• Hepatorenal Syndrome (HRS)
• Chronic Dialysis

QUELIMMUNE^™, the Company’s SCD-Pediatric device, is being commercialized following FDA approval for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with RRT. 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 1995. These forward-looking statements include, without limitation, the ability of the SCD to treat patients with AKI and other diseases; anticipated patient enrollment and the expansion of the clinical trial sites; the number of patients and annual sales for the addressable AKI market; the anticipated Medicare and Medicaid reimbursement by CMS for patients enrolled in clinical trials; planned future clinical trials; the expected regulatory approval process and timeline for commercialization of our clinical products; 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:

Alliance Advisors IR
Jody Cain
(310) 691-7100
Jcain@allianceadvisors.com

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FAQ

How many patients has SeaStar Medical (ICU) enrolled in the NEUTRALIZE-AKI trial as of November 2024?

SeaStar Medical has enrolled 65 total patients in the NEUTRALIZE-AKI trial, with 9 new patients enrolled in November 2024.

What is the market potential for SeaStar Medical's (ICU) SCD device in the AKI indication?

SeaStar Medical estimates annual peak sales of approximately $1 billion for the SCD device in the AKI indication, which affects approximately 210,000 patients in the U.S. annually.

How many sites are currently active in SeaStar Medical's (ICU) NEUTRALIZE-AKI trial?

SeaStar Medical has 13 active sites in the NEUTRALIZE-AKI trial, with Sentara Norfolk General Hospital being the latest addition.