SeaStar Medical Provides Updates On Enrollment Of Adult Pivotal Clinical Study And Commercial Launch Of Quelimmune, FDA-Approved In Pediatric Patients

Author: Benzinga Newsdesk | March 12, 2024 08:57am

Company plans to hold a business update conference call in April

DENVER, March 12, 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, provides updates on the acute kidney injury (AKI) programs it is developing with its patented, first-to-market, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill patients with AKI.

"We now have 21 subjects enrolled across five clinical sites in our NEUTRALIZE-AKI pivotal clinical trial, which is intended to evaluate the safety and efficacy of our SCD in adult AKI patients. Additional sites are progressing through the site activation and contract completion process," said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. "We expect the pace of enrollment will accelerate as more medical centers come onboard. We anticipate conducting an interim analysis once we have reached our 90-day primary endpoint in 100 enrolled subjects, which we expect to reach in the second half of 2024."

The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomiZEd clinical trial in Acute Kidney Injury) pivotal trial is expected to enroll up to 200 adults. The trial's primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD in addition to continuous kidney replacement therapy (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. More information on the trial is available here.

In February 2024 the U.S. Food and Drug Administration (FDA) granted a Humanitarian Device Exemption (HDE) Approval Order to the Quelimmune™ pediatric device for use in children weighing 10 kilograms or more with AKI due to sepsis or a septic condition requiring kidney replacement therapy (KRT).

"Interactions with several key target hospitals are underway with plans to expand the commercial rollout with Nuwellis, Inc. during the second quarter," said Eric Schlorff, CEO of SeaStar Medical. "As our therapeutic device is approved under an HDE, each hospital is required to secure institutional review board approval prior to purchasing the device for use in patients. We view Quelimmune as a tremendous win for children with AKI requiring CKRT given clinical results from our AKI pediatric trials that showed a 77% survival rate and no dialysis dependency at 60 days in those subjects, as well as for the healthcare system given the average cost of dialysis for a single patient with AKI who develops chronic kidney disease is about $100,000 annually."

SeaStar Medical estimates the eligible population for its Quelimmune pediatric device to be approximately 4,000 children annually with AKI. About 20% of the top 50 children's hospitals already have direct experience with the SCD. Pediatric patients undergoing treatment with the SCD are expected to require, on average, seven SCD units, with the disposable device being changed once every 24 hours. With the Approval Order, SeaStar Medical can build Quelimmune Clinical Kits into inventory in parallel to the hospital approvals process.

The FDA's HDE Approval Order was based on a pooled analysis from two non-controlled studies, SCD-PED-01 (funded by the FDA Office of Orphan Products Development) and SCD-PED-02. These studies showed that pediatric patients weighing ≥10kg with AKI requiring CKRT treated with the Quelimmune pediatric device had no device-related serious adverse events or device-related infections, a 77% survival rate, and no dialysis dependency at Day 60. The SCD-PED-01 (weight range ≥15 kg) and SCD-PED-02 (weight range ≥10 kg) studies demonstrated 75% and 83% survival rates, respectively.

SeaStar Medical also announces that its executive management team plans to hold a business update conference call in April to discuss progress with its AKI programs and opportunities in other indications, and to answer questions. Details regarding this call will be made available in the coming weeks.

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