FDA approves device for treatment of paediatric patients with kidney injury due to sepsis

The US Food and Drug Administration has approved a new device for treating children weighing 10 kg or more with acute kidney injury (AKI) due to sepsis or a septic condition who require kidney replacement therapy. The approval is granted to company SeaStar which is currently testing the device in critically ill patients with AKI and looking at other applications.

This is the first product in the Company’s newly branded Quelimmune product family, and the Quelimmune pediatric device can now be commercially marketed as a Humanitarian Use Device (HUD).

“This first regulatory approval is a major accomplishment for our company and, most importantly, it provides critically ill children with AKI access to a much-needed new therapy,” said Eric Schlorff, SeaStar Medical CEO. “Only about one-half of the children in the ICU with AKI requiring CKRT survive, and those who do are at increased risk of long-term conditions such as chronic kidney disease. In clinical studies, Quelimmune for pediatric AKI has been shown to reduce mortality rates and dialysis dependency in clinical studies.

“We appreciate the FDA’s willingness to work collaboratively with SeaStar Medical and our advisors to grant HDE approval to Quelimmune for pediatric use,” Mr. Schlorff added. “We believe the HDE for children weighing as little as 10 kilograms – or roughly 22 pounds – acknowledges the proven life-saving capabilities of our device and addresses a critical unmet need for patients. We are working to make Quelimmune therapy the new standard of care for AKI requiring CKRT in the ICU and to demonstrate its benefit in the many indications where hyperinflammation and dysregulated inflammatory processes are involved.”

The initial commercial launch of Quelimmune for pediatric AKI is expected in the coming weeks by SeaStar Medical’s U.S. license and distribution partner Nuwellis, with a full commercial program to follow. Nuwellis has established strong relationships with pediatric nephrology and intensive care key opinion leaders across the U.S.

“The unique technology behind Quelimmune has demonstrated great promise in making a positive impact on children with potentially deadly hyperinflammation,” said Nestor Jaramillo, Jr., Nuwellis President and CEO. “The pediatric segment of our business has gained significant traction over the past several years, and we are excited to add the Quelimmune pediatric device to our product offering.”

The FDA granted HDE approval to the Quelimmune pediatric device for AKI based upon clinical results showing safety and probable clinical benefit to critically ill children with AKI who have few treatment options. Pooled analysis from two non-controlled studies, SCD-PED-01 (funded by the FDA Office of Orphan Products Development) and SCD-PED-02 showed that pediatric patients ≥10kg with AKI requiring CKRT treated with the Quelimmune pediatric device had no device-related serious adverse events or device-related infections, a 77% reduction in mortality rate, and no dialysis dependency at Day 60. The SCD-PED-01 (weight range ≥15 kg) and PED-02 (weight range ≥10 kg) studies demonstrated 75% and 83% reductions in mortality, respectively. These data were recently published in the journal Kidney Medicine. SeaStar Medical is currently focused on its NEUTRALIZE-AKI pivotal clinical trial to evaluate Quelimmune therapy in the larger adult AKI population, while exploring other applications for this device.

About Hyperinflammation

Hyperinflammation is the overproduction or overactivity of inflammatory cells that can lead to damage of vital organs. It occurs when the body overproduces inflammatory effector cells and other molecules that can be toxic, damaging to vital organs and result in multi-organ failure and even death. This is known as the cytokine storm.

About Quelimmune

Quelimmune is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during CKRT 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 CKRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. Quelimmune 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.