CMS Grants Category B Coverage for Adults with Acute Kidney Injury Enrolled in SeaStar Medical’s Selective Cytopheretic Device Pivotal Trial
SeaStar Medical Holding (Nasdaq: ICU) has received a Category B Coverage Letter from CMS for its NEUTRALIZE-AKI pivotal trial, evaluating the Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI). This coverage is expected to accelerate medical site activations and cover a portion of the trial costs. The trial aims to enroll up to 200 adult patients with AKI at up to 30 clinical sites, with 38 patients already enrolled across 10 active centers.
CEO Eric Schlorff anticipates that CMS reimbursement will provide substantial overall cost savings and accelerate patient enrollment. The company plans to conduct an interim analysis after reaching the 90-day primary endpoint in 100 enrolled subjects. SeaStar Medical views the adult AKI market as a multibillion-dollar opportunity, given its population is 50 times larger than pediatric AKI.
- CMS Category B Coverage granted for NEUTRALIZE-AKI pivotal trial
- Expected acceleration of medical site activations
- Potential for substantial cost savings in trial expenses
- 38 patients already enrolled across 10 active centers
- Adult AKI market represents a multibillion-dollar opportunity
- Trial still in early stages with only 38 out of 200 target patients enrolled
Insights
The CMS Category B Coverage for SeaStar Medical’s NEUTRALIZE-AKI trial is significant as it introduces a potential reduction in operational costs. The reimbursement will cover both the company’s Selective Cytopheretic Device (SCD) and routine services for patients. This is important because
The NEUTRALIZE-AKI trial focuses on a significant and growing medical issue—acute kidney injury (AKI). The CMS coverage for the trial means that the investigational device is deemed to have resolved initial safety concerns, providing a level of validation to the scientific community and investors. The fact that the patient population for adult AKI is
Reimbursement expected to accelerate medical site activations and cover a portion of the Company’s NEUTRALIZE-AKI trial costs
DENVER, July 16, 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 receipt of a Category B Coverage Letter from the U.S. Centers for Medicare & Medicaid Services (CMS) for the NEUTRALIZE-AKI pivotal trial evaluating the Company’s Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI). CMS will pay for certain expenses incurred by medical centers treating patients covered by Medicare or Medicaid who are enrolled in the trial, which will cover a portion of SeaStar Medical’s trial-related costs. Specifically, SeaStar Medical’s SCD itself, as well as related and routine items and services, are approved for the purposes of Medicare coverage.
“We anticipate that CMS reimbursement will provide substantial overall cost savings for this trial while accelerating the activation of new sites, including several that have been waiting for this determination. With more trial sites activated we expect a meaningful acceleration in patient enrollment,” said Eric Schlorff, SeaStar Medical CEO.
“We look forward to sharing more information about the impact of CMS reimbursement on Medicare and Medicaid patients, and on NEUTRALIZE-AKI trial expenses. We anticipate conducting an interim analysis once we have reached our 90-day primary endpoint in 100 enrolled subjects,” he added. “Our team is highly focused on advancing this trial in adults with AKI, a patient population that is 50 times larger than pediatric AKI, making this a multibillion-dollar opportunity for our Company.”
The NEUTRALIZE-AKI trial will enroll up to 200 adult patients with AKI at up to 30 clinical sites. The first patient was enrolled in June 2023. Currently 10 medical centers have been cleared to participate in the trial and 38 patients have been enrolled.
CMS Category B provides coverage for routine care items and services, as well as the cost of a Category B investigational device if specific criteria are met. Category B devices are non-experimental, or similar devices may already be on the market. The primary risk for these devices is incremental risk, meaning initial questions about safety and effectiveness have been resolved. The grants allow Medicare Administrative Contractors to make coverage decisions for Category B investigational devices and routine care services in their review of claims for payment for these items and services. SeaStar Medical’s claim for Category B coverage included the Breakthrough Device Designation granted by FDA for the adult AKI indication, the protocol for the NEUTRALIZE-AKI trial, and the Institutional Review Board (IRB) approval letter.
About the Pivotal NEUTRALIZE-AKI Trial
SeaStar Medical’s pivotal NEUTRALIZE-AKI (NEUTRophil and Monocyte DeActivation via SeLective CytopheretIc Device - a RandomiZEd Clinical Trial in Acute Kidney Injury) clinical trial is evaluating the safety and efficacy of the SCD in adults with AKI in the ICU receiving continuous kidney replacement therapy (CKRT). 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. The SCD-ADULT has received FDA Breakthrough Device Designation for adult AKI. This designation 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.
About the Selective Cytopheretic Device (SCD)
The SCD is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous kidney renal therapy (KRT) and reduces the hyperinflammatory milieu including the cytokine storm that causes inflammation, organ failure and possible death in critically ill patients. Unlike pathogen removal and other blood-purification tools, the device is integrated with KRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. The SCD selectively targets the most highly activated proinflammatory neutrophils and monocytes. These cells are then returned back into the body through the blood, and the body is signaled to lower its inflammatory environment and focus on repair. This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future KRT, including dialysis.
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 the ability of SCD to treat patients with AKI and other diseases; anticipated patient enrollment and the expansion of the clinical trial sites; 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.
Investor Contact:
LHA Investor Relations
Jody Cain
(310) 691-7100
Jcain@lhai.com
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