{"id":803174,"date":"2025-01-22T07:34:52","date_gmt":"2025-01-22T12:34:52","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/seastar-medical-activates-15th-site-for-its-adult-acute-kidney-injury-pivotal-trial\/"},"modified":"2025-01-22T07:34:52","modified_gmt":"2025-01-22T12:34:52","slug":"seastar-medical-activates-15th-site-for-its-adult-acute-kidney-injury-pivotal-trial","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/seastar-medical-activates-15th-site-for-its-adult-acute-kidney-injury-pivotal-trial\/","title":{"rendered":"SeaStar Medical Activates 15th Site for its Adult Acute Kidney Injury Pivotal Trial"},"content":{"rendered":"
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\n DENVER, Jan. 22, 2025 (GLOBE NEWSWIRE) — <\/strong>
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\n SeaStar Medical Holding Corporation<\/u>
\n <\/a> (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\u2019s NEUTRALIZE-AKI pivotal trial, increasing the number of activated sites to 15.<\/p>\n

\u201cWe are thrilled to activate another large academic center to our study,\u201d said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. \u201cEnrollment 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<\/sup> subject for our interim analysis soon.\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.<\/p>\n

\n NEUTRALIZE-AKI Pivotal Trial\u00a0<\/strong>
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The NEUTRALIZE-AKI<\/u><\/a> (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device \u2013 a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of SeaStar Medical\u2019s 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\u2019s 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.\u00a0<\/p>\n

SeaStar Medical plans to conduct an interim analysis at the trial\u2019s 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.<\/p>\n

\n Acute Kidney Injury (AKI) and Hyperinflammation\u00a0<\/strong>
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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.\u00a0<\/p>\n

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.<\/p>\n

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

In addition to Adult AKI, the SCD has been awarded FDA Breakthrough Device Designation in the following indications:<\/p>\n