SeaStar Medical Signed US License and Distribution Agreement with Nuwellis for Selective Cytopheretic Device to Treat Acute Kidney Injury in Pediatric Patients
Shots:
- The companies collaborated to market & distribute SeaStar’s SCD, a patented, cell-directed extracorporeal therapy for AKI in children. The device will continue to advance in additional indication i.e., for the adult AKI population in the planned pivotal trial with an expected initiation in Q1’23
- SCD can selectively target the activated pro-inflammatory neutrophils & monocytes to stop cytokine storm. The device works with CKRT to help the body return to homeostasis
- SeasStar expects the US FDA to complete a substantive review of a humanitarian device exemption (HDE) for SCD in children in Q1’23 with commercial launch expected in Q2’23. Clinical studies showed SCD's potential to end patients' dependency on dialysis, reduce ICU time & save their lives
Ref: Globe Newswire | Image: Seastar
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