Michael Barbella, Managing Editor03.03.23
SeaStar Medical Holding Corporation and Nuwellis Inc. have commenced an exclusive U.S. license and distribution agreement for SeaStar Medical’s Selective Cytopheretic Device (SCD) for treating acute kidney injury (AKI) in children. Nuwellis will market and distribute the SCD through its direct salesforce to nephrologists and intensive care physicians trained in pediatric extracorporeal therapy. SeaStar Medical expects the U.S. Food and Drug Administration (FDA) to complete a substantive review of a Humanitarian Device Exemption (HDE) for the use of SCD in children (>20 kg.) with AKI during the first quarter of 2023, with a potential commercial introduction in the second quarter of 2023.
“Nuwellis’ established relationships with pediatric nephrology and intensive care key opinion leaders make them the ideal marketing partner for SCD in this indication,” SeaStar Medical CEO Eric Schlorff said. “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.”
SCD is a patented, cell-directed extracorporeal therapy that selectively targets the most activated pro-inflammatory neutrophils and monocytes to stop the cytokine storm that frequently causes organ failure and possible death in critically ill patients. The therapy works with CKRT to target and neutralize pro-inflammatory neutrophils and monocytes, allowing the body to return to homeostasis. Clinical studies have demonstrated SCD’s potential to eliminate dialysis dependency, shorten ICU time and restore the lives of critically ill patients.1,2,3
“We share a commitment with SeaStar Medical to bring potentially lifesaving therapies to children undergoing CKRT therapy,” Nuwellis President/CEO Nestor Jaramillo Jr. said. “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.”
Each year approximately 4,000 U.S. children with AKI require CKRT and those patients are associated with an approximately 50% mortality rate. Children who survive an AKI episode are at risk for long-term conditions, including chronic kidney disease (CKD).1
Nuwellis Inc. is a medical technology company focused on commercializing the Aquadex SmartFlow system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland.
SeaStar Medical is a medical technology company focusing on redefining the ways in which extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical’s technologies rely on science and innovation to provide life-saving solutions to critically ill patients. The company is developing and commercializing extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses.
References
1 Goldstein, Stuart L., et al. “Use of the Selective Cytopheretic Device in Critically Ill Children.” Kidney International Reports, vol. 6, no. 3, 18 Dec. 2020, pp. 775–784., https://doi.org/10.1016/j.ekir.2020.12.010.
2 Tumlin, James A., et al. “A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with Acute Kidney Injury.” PLOS ONE, vol. 10, no. 8, 2015, https://doi.org/10.1371/journal.pone.0132482.
3 Yessayan, Lenar T., et al. “Extracorporeal Immunomodulation Treatment and Clinical Outcomes in ICU COVID-19 Patients.” Critical Care Explorations, vol. 4, no. 5, 19 May 2022, https://doi.org/10.1097/cce.0000000000000694.
“Nuwellis’ established relationships with pediatric nephrology and intensive care key opinion leaders make them the ideal marketing partner for SCD in this indication,” SeaStar Medical CEO Eric Schlorff said. “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.”
SCD is a patented, cell-directed extracorporeal therapy that selectively targets the most activated pro-inflammatory neutrophils and monocytes to stop the cytokine storm that frequently causes organ failure and possible death in critically ill patients. The therapy works with CKRT to target and neutralize pro-inflammatory neutrophils and monocytes, allowing the body to return to homeostasis. Clinical studies have demonstrated SCD’s potential to eliminate dialysis dependency, shorten ICU time and restore the lives of critically ill patients.1,2,3
“We share a commitment with SeaStar Medical to bring potentially lifesaving therapies to children undergoing CKRT therapy,” Nuwellis President/CEO Nestor Jaramillo Jr. said. “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.”
Each year approximately 4,000 U.S. children with AKI require CKRT and those patients are associated with an approximately 50% mortality rate. Children who survive an AKI episode are at risk for long-term conditions, including chronic kidney disease (CKD).1
Nuwellis Inc. is a medical technology company focused on commercializing the Aquadex SmartFlow system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland.
SeaStar Medical is a medical technology company focusing on redefining the ways in which extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical’s technologies rely on science and innovation to provide life-saving solutions to critically ill patients. The company is developing and commercializing extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses.
References
1 Goldstein, Stuart L., et al. “Use of the Selective Cytopheretic Device in Critically Ill Children.” Kidney International Reports, vol. 6, no. 3, 18 Dec. 2020, pp. 775–784., https://doi.org/10.1016/j.ekir.2020.12.010.
2 Tumlin, James A., et al. “A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with Acute Kidney Injury.” PLOS ONE, vol. 10, no. 8, 2015, https://doi.org/10.1371/journal.pone.0132482.
3 Yessayan, Lenar T., et al. “Extracorporeal Immunomodulation Treatment and Clinical Outcomes in ICU COVID-19 Patients.” Critical Care Explorations, vol. 4, no. 5, 19 May 2022, https://doi.org/10.1097/cce.0000000000000694.