SeaStar Medical Activates 14th Hospital for its Adult AKI Pivotal Trial

Rhea-AI Summary

SeaStar Medical (Nasdaq: ICU) has activated its 14th hospital site for the NEUTRALIZE-AKI pivotal trial, evaluating their Selective Cytopheretic Device (SCD) in acute kidney injury patients. Currently, 70 of 200 planned subjects are enrolled, with 24 in Q4. The company expects Data Safety Monitoring Board interim results by mid-2025 after the first 100 subjects complete the 90-day primary endpoint.

The company estimates the U.S. addressable market for SCD in adult AKI at $4.7-6.3 billion, with trial costs around $15 million. The SCD has FDA Breakthrough Device Designation for adults with AKI, and received Category B coverage from CMS for certain expenses in July 2024. The trial's primary endpoint focuses on 90-day mortality or dialysis dependency comparing SCD plus CRRT versus CRRT alone.

Positive

• 70 out of 200 subjects already enrolled in pivotal trial
• Large addressable market of $4.7-6.3 billion for adult AKI indication
• FDA Breakthrough Device Designation obtained
• CMS Category B coverage granted for trial expenses
• 24 subjects enrolled in Q4 showing enrollment momentum

Negative

• Trial costs estimated at $15 million
• Final results not expected until after mid-2025

Insights

Clinical Trial Expert

The activation of the 14th hospital site in SeaStar Medical's NEUTRALIZE-AKI pivotal trial represents meaningful progress, with 70 out of 200 planned subjects enrolled and 24 enrollments in Q4 alone. The trial's design focusing on 90-day mortality and dialysis dependency endpoints is particularly robust. The interim analysis planned at 100 subjects by mid-2025 could provide important efficacy signals. The Category B Medicare/Medicaid coverage granted in July 2024 significantly reduces financial barriers for trial sites and should accelerate enrollment. The trial's $15 million cost is relatively modest given the potential $4.7-6.3 billion market opportunity.

The multiple FDA Breakthrough Device Designations across four indications (CRS-LVAD, AKI, HRS and Chronic Dialysis) demonstrate the platform's broad potential. The recent FDA approval of QUELIMMUNE™ for pediatric AKI under HDE provides early validation of the technology's safety profile and clinical utility.

Medical Device Analyst

The SCD's unique immunomodulation mechanism targeting proinflammatory neutrophils and monocytes differentiates it from conventional blood purification approaches. Integration with existing CRRT systems should facilitate adoption, while the potential to eliminate long-term dialysis dependency addresses a critical unmet need. The recent commercialization of QUELIMMUNE™ for pediatric use provides valuable real-world implementation experience and could accelerate market penetration for adult indications. The 70 patient enrollment milestone in the pivotal trial shows strong execution and site engagement, critical factors for eventual commercial success.

The multiple Breakthrough Device Designations across diverse indications validate the platform's versatility and suggest significant expansion potential beyond the initial AKI market. The Category B coverage decision notably de-risks the commercialization pathway by ensuring early reimbursement support.

DENVER, Dec. 23, 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 a 14^th site is now activated and able to enroll subjects in the NEUTRALIZE-AKI pivotal trial. The NEUTRALIZE-AKI trial is evaluating the safety and efficacy of the Company’s proprietary therapeutic Selective Cytopheretic Device (SCD) in patients with acute kidney injury (AKI) in the intensive care unit (ICU) receiving continuous renal replacement therapy (CRRT).

“We are pleased to welcome the 14^th hospital to our trial, especially as this site has been among the top CRRT programs in the country,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “As of today, 70 of the planned 200 subjects have been enrolled, including 24 so far in the fourth quarter. We plan to conduct an interim analysis at the trial’s 90-day primary endpoint with the first 100 subjects. Given the current pace of enrollment, we anticipate a Data Safety Monitoring Board (DSMB) recommendation on the interim results by mid-2025.”

“We estimate the annual U.S. total addressable market for the SCD in adult AKI at $4.7 billion to $6.3 billion. This significant market opportunity represents a highly attractive return on a clinical trial estimated to cost SeaStar Medical approximately $15 million, with some of those costs already incurred,” said Eric Schlorff, SeaStar Medical CEO. “AKI is one of several high-value indications for our SCD that we plan to pursue. As we work to increase accessibility of our therapeutic device among those afflicted with potentially life-threatening hyperinflammation, we believe that our clinical data showing reduced mortality and probable savings for the healthcare system will encourage adoption by the medical community.”

The 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 estimated 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; expected clinical trial costs; the adoption of our products by the medical community; 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

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

The trial has enrolled 70 out of 200 planned subjects, with 24 enrollments in Q4 2024, across 14 activated hospital sites.

When will SeaStar Medical (ICU) release interim results for the NEUTRALIZE-AKI trial?

The company expects to receive Data Safety Monitoring Board recommendations on interim results by mid-2025, after the first 100 subjects complete the 90-day primary endpoint.

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

The company estimates the annual U.S. total addressable market for SCD in adult AKI at $4.7 billion to $6.3 billion.

What regulatory designations has SeaStar Medical's SCD (ICU) received for adult AKI?

The SCD has received FDA Breakthrough Device Designation for adults with AKI and CMS Category B coverage for certain trial expenses in July 2024.

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

The primary endpoint is a composite of 90-day mortality or dialysis dependency among patients treated with SCD plus CRRT compared to those receiving only CRRT standard of care.