Medical technology company Nuwellis has announced that the first paediatric patient has been treated with the newly launched Quelimmune therapy in a commercial setting.
Manufactured by SeaStar Medical, Quelimmune is a medical device designed to treat paediatric patients (weighing 10 kg or more) with acute kidney injury (AKI) due to sepsis or a septic condition and requiring kidney replacement therapy (KRT).
Nuwellis holds the exclusive licence to distribute it in US paediatric hospitals.
As a cell-directed extracorporeal device, Quelimmune uses immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during KRT.
It helps in reducing the hyperinflammatory milieu including the cytokine storm, organ failure and possible death in critically ill patients.
The first patient was treated at Cincinnati Children’s hospital. The administration was overseen by Cincinnati Children’s Center for Acute Care Nephrology director Dr Stuart Goldstein. He was also the principal investigator of the multi-centre studies that led to FDA clearance of Quelimmune.
Dr Goldstein said: “The ability to mitigate the devastating effects of a cytokine storm caused by acute kidney injury and sepsis holds significant promise for improving patient outcomes. This therapy represents an advancement in our efforts to provide the best care possible to these vulnerable patients.”
Nuwellis president and CEO Nestor Jaramillo said: “We are thrilled to introduce Quelimmune to critically ill paediatric patients in need. This marks a significant step forward in Nuwellis’ mission to execute our paediatric business development strategy.
“By partnering with SeaStar Medical, we are committed to bringing this groundbreaking therapy to US healthcare providers, offering new hope to children suffering from severe immune system reactions.”
