SeaStar Medical Announces CMS Coverage for Medicare and Medicaid Eligible Patients with Cardiorenal Syndrome Awaiting LVAD in Investigational Trial of SCD Therapy

Rhea-AI Summary

SeaStar Medical (NASDAQ: ICU) has secured CMS coverage for Medicare and Medicaid patients enrolled in the NEUTRALIZE-CRS clinical trial, marking its second CMS reimbursement award. The trial evaluates the company's Selective Cytopheretic Device (SCD) therapy in patients with cardiorenal syndrome awaiting LVAD implantation. This rare achievement, granted to less than 100 trials annually, follows their July 2024 CMS coverage for the NEUTRALIZE-AKI pivotal trial. The company is also advancing pre-commercialization efforts for SCD therapy in Acute Kidney Injury (AKI) patients, with the NEUTRALIZE-AKI trial currently 50% enrolled. Both the AKI and cardiorenal syndrome applications have received FDA Breakthrough Device Designation. The NEUTRALIZE-CRS trial, supported by a $3.6M NIH grant, aims to enroll 20 patients across five clinical sites.

Positive

• Secured rare CMS coverage for second clinical trial, indicating strong potential of the technology
• FDA Breakthrough Device Designation obtained for both AKI and cardiorenal syndrome applications
• Received $3.6M NIH grant for NEUTRALIZE-CRS trial
• NEUTRALIZE-AKI pivotal trial is 50% enrolled, showing steady progress
• Building compelling case for CMS and private payer reimbursement based on HEOR data showing reduced healthcare costs

Negative

• Full enrollment of NEUTRALIZE-AKI trial not expected until end of 2025
• Small patient size (20) for NEUTRALIZE-CRS trial may limit initial data significance

Insights

Healthcare Regulatory Expert

SeaStar received rare CMS reimbursement for two clinical trials, strengthening commercialization pathway for their innovative organ-failure treatment technology.

SeaStar Medical has secured Centers for Medicare & Medicaid Services (CMS) coverage for patients enrolled in their NEUTRALIZE-CRS clinical trial, marking their second CMS reimbursement award after receiving the first in July 2024 for their NEUTRALIZE-AKI pivotal trial. This achievement is particularly significant as fewer than 100 clinical trials annually receive such coverage, indicating strong regulatory confidence in their Selective Cytopheretic Device (SCD) therapy.

The SCD technology represents a novel disease-modifying approach that neutralizes hyperactive immune cells to prevent cytokine storms and subsequent inflammation that damages organs in critically ill patients. The device is being evaluated in two key trials: the NEUTRALIZE-AKI pivotal trial (currently 50% enrolled) testing the therapy in adults with Acute Kidney Injury in ICU settings, and the NEUTRALIZE-CRS trial for patients with acute heart failure and worsening renal function awaiting left ventricular assist device implantation.

This CMS coverage decision strengthens SeaStar's commercialization pathway in multiple ways. First, it reduces financial barriers for trial participation, potentially accelerating enrollment in both trials. Second, it establishes a precedent for post-approval coverage, as the company has already engaged reimbursement experts to build a case for permanent coverage following potential FDA approval. Third, the FDA has granted Breakthrough Device Designation for both indications, further validating the technology's potential to address serious unmet medical needs.

The company is strategically positioning its technology as not just clinically effective but also economically beneficial, emphasizing Healthcare Economics and Outcomes Research data showing reduced healthcare costs with their therapy. This dual clinical-economic value proposition will be crucial for securing broader commercial reimbursement coverage upon potential FDA approval.

Coverage marks SeaStar Medical’s second award by CMS for reimbursement of medical expenses for Medicare and Medicaid patients in a clinical trial

Stands out as rare award with less than 100 clinical trials covered annually

DENVER, May 28, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced today that the U.S. Centers for Medicare & Medicaid Services (CMS) has agreed to pay for certain expenses incurred by medical centers treating patients covered by Medicare or Medicaid who are enrolled in the NEUTRALIZE-CRS investigational clinical trial. This follows the company’s first award for reimbursement by the CMS that was granted in July 2024 for qualified patients treated in the ongoing NEUTRALIZE-AKI pivotal clinical trial.

“To receive CMS coverage of certain expenses for patients in a clinical trial is rare, with less than 100 per year, and we believe reflects the life-saving potential of our technology,” said Eric Schlorff, SeaStar Medical CEO. “We fulfilled multiple criteria set forth by the CMS for this award, including ten study criteria elements that included assessment of how we could improve health outcomes, how generalizable the Selective Cytopheretic Device (SCD) therapy would be to the Medicare population, and how the study results would not duplicate existing knowledge.”

Mr. Schlorff continued, "As we initiate our pre-commercialization efforts for our SCD therapy in patients with Acute Kidney Injury (AKI), we recognize that CMS coverage in the commercial setting will be a key element to bringing our potential organ-sparing and life-saving therapies to more patients. We have already engaged a third-party reimbursement policy expert to analyze the feasibility of obtaining reimbursement coverage upon a potential FDA approval for our SCD therapy in adult patients with AKI. Based on the results of the analysis, the high unmet need, and Healthcare Economics and Outcomes Research (HEOR) data supporting reduced healthcare costs, we are building a compelling case that should enable CMS and private payers to understand the value of the SCD therapy in adult patients with AKI."

The NEUTRALIZE-AKI pivotal clinical trial and NEUTRALIZE-CRS investigational clinical trial are evaluating the ability of SeaStar Medical’s SCD therapy to neutralize destructive hyperinflammation to improve health outcomes. The SCD therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body.

The NEUTRALIZE-AKI pivotal trial was granted CMS coverage in July 2024 for qualified patients. The trial is evaluating the safety and efficacy of the SCD therapy in 200 adults with AKI in the ICU receiving CRRT. It is currently 50% enrolled, with full enrollment anticipated near the end of 2025. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to CRRT as the standard of care, compared with the control group receiving only CRRT standard of care. The FDA has granted Breakthrough Device Designation for the SCD therapy in adult patients with AKI and CRRT.

The NEUTRALIZE-CRS trial is designed to evaluate the safety and initial efficacy of the SCD therapy in reducing destructive hyperinflammation in adult patients with acute heart failure with worsening renal function due to cardiorenal syndrome or severe right ventricular failure awaiting a left ventricular assist device (LVAD) implantation. The trial is expected to enroll 20 patients at up to five clinical sites and will be funded by a previously announced $3.6 million National Institutes of Health (NIH) grant awarded to Innovative BioTherapies (IBT), which is led by SCD inventor H. David Humes, MD, Professor, Division of Nephrology, Internal Medicine, University of Michigan and SeaStar Medical Scientific Advisor. Dr. Humes will serve as lead investigator for the study and SeaStar Medical will act as clinical research organization (CRO). The FDA has granted Breakthrough Device Designation for the SCD in cardiorenal syndrome awaiting LVAD implantation.

About SeaStar Medical

SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. SeaStar’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis or a septic condition in critically ill pediatric patients. SeaStar’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually.

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 benefits and cost savings from our products; the expected regulatory approval process and timeline for our 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 secure additional financing on acceptable terms; (vi) the risk that third-party 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. 

For more information visit www.seastarmedical.com or visit us on LinkedIn or X.

Contact:
SeaStar Investor Relations:
IR@SeaStarMed.com

FAQ

What is the significance of CMS coverage for SeaStar Medical's (ICU) clinical trials?

CMS coverage for SeaStar Medical's trials is significant as it's a rare achievement granted to less than 100 trials annually. It allows reimbursement of medical expenses for Medicare and Medicaid patients in their trials and indicates the life-saving potential of their technology.

What is SeaStar Medical's (ICU) SCD therapy being tested for?

SeaStar Medical's SCD therapy is being tested in two trials: NEUTRALIZE-AKI for patients with Acute Kidney Injury, and NEUTRALIZE-CRS for patients with cardiorenal syndrome awaiting LVAD implantation. Both applications have received FDA Breakthrough Device Designation.

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

The NEUTRALIZE-AKI pivotal trial is currently 50% enrolled, evaluating 200 adults with AKI in the ICU. Full enrollment is anticipated by the end of 2025.

How is SeaStar Medical's (ICU) NEUTRALIZE-CRS trial being funded?

The NEUTRALIZE-CRS trial is being funded by a $3.6 million National Institutes of Health (NIH) grant awarded to Innovative BioTherapies (IBT), led by SCD inventor Dr. H. David Humes.

What are the commercialization plans for SeaStar Medical's (ICU) SCD therapy?

SeaStar Medical is initiating pre-commercialization efforts for SCD therapy in AKI patients and has engaged a third-party expert to analyze reimbursement coverage feasibility upon potential FDA approval, building a case for CMS and private payer coverage based on HEOR data.