SeaStar Medical Holding Corporation (Nasdaq: ICU) has officially activated Good Samaritan Regional Medical Center in Corvallis, Oregon as the first clinical site in its groundbreaking NEUTRALIZE-AKI trial.
This pivotal trial, which will involve up to 30 U.S. sites, is assessing the safety and efficacy of SeaStar Medical’s Selective Cytopheretic Device (SCD) extracorporeal therapy for critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT). This pioneering treatment, which is the first of its kind, seeks to reduce the consequences of hyperinflammation on vital organs.
SeaStar Medical is excited to announce that it has recently received FDA approval to initiate a pivotal trial of its cutting-edge Shockwave Coronary Dilator (SCD) to reduce mortality and dialysis dependency in critically ill patients.
The NEUTRALIZE-AKI trial was activated at the first clinical site with remarkable speed, and more sites are expected to join soon. Previous clinical studies have already demonstrated the positive impact of the SCD, and SeaStar Medical is thrilled to be able to bring this device to the broader population.
We are thrilled to be the first clinical site activated in the NEUTRALIZE-AKI clinical study, and can’t wait to assess SCD therapy’s potential to improve outcomes for critically ill patients. Brian Delmonaco, MD, FACEP, Medical Director of Samaritan Health Services Pulmonology and Critical Care Medicine and principal investigator for Good Samaritan Regional Medical Center, is leading this groundbreaking effort.
Four studies conducted prior to the coronavirus pandemic have demonstrated the safety and effectiveness of the SCD for adults and children with AKI requiring CKRT. The results showed an impressive Day 60 mortality reduction of up to 50%, with no need for dialysis, compared to the 15-25% dialysis dependency in historical controls.
The NEUTRALIZE-AKI trial is an exciting clinical study that aims to assess the safety and efficacy of a novel cytopheretic device, the Selective Cytopheretic Device (SCD), in the treatment of acute kidney injury (AKI).
Up to 200 patients will be enrolled in the study, and its primary endpoint will be a composite of mortality or dialysis dependency at 90 days, while 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.
Additionally, there will be subgroup analyses to explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. This is a unique opportunity to assess a potential breakthrough in AKI treatment!
Each year, an astonishing six million American adults and children are diagnosed with acute kidney injury (AKI), and more than 200,000 of them require a complex procedure known as Continuous Kidney Replacement Therapy (CKRT).
In 2022, the SCD was awarded the coveted FDA Breakthrough Device Designation for adult use – a designation which is bestowed upon therapies that can potentially provide a substantial improvement over existing treatments for serious or life-threatening conditions. Such therapies are given priority review and development, allowing for an expedited path to revolutionizing patient care.
About Good Samaritan Regional Medical Center
The NEUTRALIZE-AKI trial is a groundbreaking research study that will evaluate the safety and effectiveness of a revolutionary new cytopheretic device, the Selective Cytopheretic Device (SCD), in the treatment of acute kidney injury (AKI).
Up to 200 participants will take part in the trial, and its primary endpoint is a combination of mortality or dialysis dependency at 90 days. Secondary endpoints such as 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 will also be assessed.
As an added bonus, subgroup analyses will be conducted to explore the efficacy of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. This is a remarkable opportunity to assess a potentially life-saving therapy for AKI!
About Hyperinflammation
Hyperinflammation is a potentially life-threatening condition that occurs when the body produces an excessive amount of inflammatory cells and molecules. This overactivation of the immune system can lead to severe tissue and organ damage, multi-organ failure, and even death.
Fortunately, the Sickle Cell Disease (SCD) therapy has been developed to selectively target the most highly activated proinflammatory neutrophils and monocytes, turning them off in a low calcium environment.
The SCD therapy mimics nature and neutralizes these cells in a unique micro-environment before returning them back into the body and signaling the body to focus on healing and repair. In this way, SCD therapy can provide a safe and effective treatment for hyperinflammation.
About SeaStar Medical
At SeaStar Medical, we believe in pioneering the future of medical technology. Our revolutionary extracorporeal therapies are redefining how excessive inflammation can be managed and its harmful effects on vital organs minimized.
We are dedicated to harnessing the power of science and innovation to bring life-saving solutions to critically ill patients. Our novel cell-directed extracorporeal therapies target the effector cells that initiate and propagate imbalanced immune responses, thereby curtailing tissue damage and production of pro-inflammatory cytokines.