{"id":796670,"date":"2024-12-23T07:03:42","date_gmt":"2024-12-23T12:03:42","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/seastar-medical-activates-14th-hospital-for-its-adult-aki-pivotal-trial\/"},"modified":"2024-12-23T07:03:42","modified_gmt":"2024-12-23T12:03:42","slug":"seastar-medical-activates-14th-hospital-for-its-adult-aki-pivotal-trial","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/seastar-medical-activates-14th-hospital-for-its-adult-aki-pivotal-trial\/","title":{"rendered":"SeaStar Medical Activates 14th Hospital for its Adult AKI Pivotal Trial"},"content":{"rendered":"
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\n DENVER, Dec. 23, 2024 (GLOBE NEWSWIRE) — <\/strong>
\n SeaStar Medical Holding Corporation<\/a> (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that a 14th<\/sup> site is now activated and able to enroll subjects in the NEUTRALIZE-AKI pivotal trial<\/a>. The NEUTRALIZE-AKI trial is evaluating the safety and efficacy of the Company\u2019s 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).<\/p>\n

\u201cWe are pleased to welcome the 14th<\/sup> hospital to our trial, especially as this site has been among the top CRRT programs in the country,\u201d said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. \u201cAs 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\u2019s 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.\u201d<\/p>\n

\u201cWe 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,\u201d said Eric Schlorff, SeaStar Medical CEO. \u201cAKI 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.\u201d<\/p>\n

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.<\/p>\n

\n NEUTRALIZE-AKI Pivotal Trial<\/strong>\n <\/p>\n

The\u00a0NEUTRALIZE-AKI<\/a> (NEUTR<\/strong>ophil and monocyte deA<\/strong>ctivation via SeL<\/strong>ective Cytopheretic Device \u2013 a randomIZE<\/strong>d clinical trial in Acute Kidney Injury) is expected to enroll up to 200 adults. The trial\u2019s 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.<\/p>\n

\n Acute Kidney Injury (AKI) and Hyperinflammation<\/strong>\n <\/p>\n

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.<\/p>\n

\n Selective Cytopheretic Device<\/strong>\n <\/p>\n

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.<\/p>\n

The SCD has been awarded FDA Breakthrough Device Designation in four indications:<\/p>\n