ICU SeaStar Medical Holding Corporation

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 Mayo Clinic is now cleared to enroll subjects in the company’s NEUTRALIZE-AKI pivotal trial, increasing the number of activated sites to 15.

“We are thrilled to activate another large academic center to our study,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “Enrollment in the trial currently stands at 76 with six subjects enrolled since the first of the year. We look forward to our next major milestone of reaching our 100th subject for our interim analysis soon.”

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.

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 evaluating the safety and efficacy of SeaStar Medical’s proprietary therapeutic SCD in 200 adults with acute kidney injury (AKI) in the intensive care unit (ICU) receiving continuous renal replacement therapy (CRRT). The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of 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. 

SeaStar Medical plans to conduct an interim analysis at the trial’s 90-day primary endpoint with the first 100 subjects. Given the current pace of enrollment, the company anticipates a Data Safety Monitoring Board (DSMB) recommendation on the interim results by mid-2025.

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. 

According to SeaStar Medical estimates, the annual U.S. total addressable market for the SCD in the adult AKI indication is $4.7 billion to $6.3 billion. AKI is one of several high-value indications for the SCD that the company plans to pursue. As accessibility to its therapeutic device by patients afflicted with potentially life-threatening hyperinflammation increases, SeaStar Medical believes that its clinical data demonstrating reduced mortality and probable savings for the healthcare system will encourage adoption by the medical community.

Selective Cytopheretic DeviceThe Selective Cytopheretic Device (SCD) 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 and neutrophils to a reparative state. This unique immunomodulation approach has been shown to promote long-term organ recovery and eliminate the need for future renal replacement therapy (RRT), including dialysis.

In addition to Adult AKI, the SCD has been awarded FDA Breakthrough Device Designation in the following indications:

• Cardiorenal Syndrome with Left Ventricular Assist Device
• Hepatorenal Syndrome
• Chronic Dialysis

About SeaStar MedicalSeaStar 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 StatementsThis 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 Company’s ability to gain market share in the AKI market; the timing of current and planned future clinical trials; and anticipated cost savings for patients, healthcare providers, and the healthcare system more generally from the adoption of the SCD. 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 IRJody Cain(310) 691-7100Jcain@allianceadvisors.com

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