SeaStar Medical has entered an exclusive US licence and distribution agreement with Nuwellis for its Selective Cytopheretic Device (SCD) for the treatment of acute kidney injury (AKI) in children.
Under the deal, Nuwellis will be responsible for the marketing and distribution of SeaStar’s SCD through its direct salesforce to nephrologists and intensive care physicians who are trained in paediatric extracorporeal therapy.
The SCD is a patented and cell-directed extracorporeal therapy, which selectively targets the most activated pro-inflammatory neutrophils and monocytes to restrict the cytokine storm, which can lead to organ failure and possible death in patients who are critically ill.
The therapy is claimed to work with continuous kidney replacement therapy (CKRT) to target and neutralise pro-inflammatory neutrophils and monocytes, thereby enabling the body to return to homeostasis.
According to the company, clinical trials have shown the SCD’s potential to eliminate dialysis dependency and reduce time spent in intensive care units (ICU).
SeaStar Medical CEO Eric Schlorff said: “Nuwellis’ established relationships with pediatric nephrology and intensive care key opinion leaders make them the ideal marketing partner for SCD in this indication.
“With Nuwellis, we have a proven, efficient means to reach our target customers while allowing SeaStar Medical to advance additional indications including a planned pivotal clinical trial in the adult acute kidney injury population, which we expect to initiate during the first quarter of 2023.”
SeaStar is also anticipating that the US Food and Drug Administration (FDA) will conclude a substantive review of a Humanitarian Device Exemption (HDE) for the use of SCD in children (>20kg) with AKI in the first quarter of the year.
The company is planning the commercial introduction of the device in Q2 2023.