Nuwellis agreed to market and distribute SeaStar’s selective cytopheretic device (SCD). The SCD treats acute kidney injury (AKI) in children. It selectively targets the most activated pro-inflammatory neutrophils and monocytes to stop cytokine storm. The system works with continuous kidney replacement therapy (CKRT) to help the body return to homeostasis.
“We share a commitment with SeaStar Medical to bring potentially lifesaving therapies to children undergoing CKRT therapy,” said Nestor Jaramillo, Jr., Nuwellis president and CEO. “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.”
Nuwellis’ plans for marketing and distribution
Minneapolis-based Nuwellis plans to market through its direct salesforce to nephrologists and intensive care physicians. Denver-based SeasStar expects the FDA to complete a review of a humanitarian device exemption (HDE) for SCD. It anticipates this could come in the first quarter of 2023. A potential commercial introduction could follow in the following quarter.
“Nuwellis’ established relationships with pediatric nephrology and intensive care key opinion leaders make them the ideal marketing partner for SCD in this indication,” said Eric Schlorff, CEO of SeaStar Medical. “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.”