US-based SeaStar Medical has entered into an exclusive US license and distribution agreement for its Selective Cytopheretic Device (SCD) with Nuwellis for its use in the treatment of acute kidney injury (AKI) in children.
According to SeaStar Medical, Selective Cytopheretic Device is a cell-directed extracorporeal therapy that preferentially targets the most activated pro-inflammatory neutrophils and monocytes to prevent the cytokine storm that commonly results in organ failure and potential death in critically ill patients.
As per the terms of the agreement, Nuwellis by using its direct salesforce will be marketing and distributing the device to intensive care physicians and nephrologists, who are trained in pediatric extracorporeal therapy.
SeaStar Medical said that the US Food and Drug Administration (FDA) is expected to finish a substantive review of a humanitarian device exemption (HDE) for the use of its Selective Cytopheretic Device in children weighing over 20kgs with AKI during Q1 2023.
The medical technology company hopes to commercially introduce the device in Q2 2023.
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.”
The Selective Cytopheretic Device is designed to work with continuous kidney replacement therapy (CKRT) for targeting and neutralising pro-inflammatory neutrophils and monocytes. This enables the body to return to homeostasis, as per SeaStar Medical.
The company said that clinical studies have shown the potential of the device in removing dialysis dependency, reduce ICU time, and restore the lives of severely ill patients.
Nuwellis president and CEO Nestor Jaramillo, Jr. said: “We share a commitment with SeaStar Medical to bring potentially lifesaving therapies to children undergoing CKRT therapy.
“To this end, we are also currently developing a new, fully integrated pediatric CKRT device designed to provide care for small babies and children under 20 kg., and we remain committed to developing and bringing to market safe innovations to address these critical unmet needs.
“As with fluid overload, critical care clinicians face an uphill battle to save pediatric patients from potentially deadly hyperinflammation. SCD’s unique approach has shown a significant impact on saving lives and reducing hospital stays.”
