Nuwellis Provides Regulatory Update on SeaStar Medical's Selective Cytopheretic Device Use in Pediatric Acute Kidney Injury Under a Humanitarian Device Exemption

Nuwellis, a medical technology company dedicated to improving the lives of individuals with fluid overload, has announced a significant development in its partnership with SeaStar Medical. The U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has indicated that SeaStar’s Selective Cytopheretic Device (SCD) Pediatric (SCD-PED) is considered approvable under a Humanitarian Device Exemption (HDE) for use in children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or a septic condition requiring continuous kidney replacement therapy (CKRT) in the hospital intensive care unit (ICU).

This positive correspondence from the FDA marks a significant step towards the approval of SeaStar’s SCD-PED. An Approvable Letter is expected to be issued within a month, outlining the conditions for formal marketing approval, including safety language, probable benefit, and labeling for intended use.

The collaboration between Nuwellis and SeaStar began in December 2022 when they entered into a U.S. license and distribution agreement for SeaStar Medical’s SCD for pediatric AKI. As part of this agreement, Nuwellis will leverage its direct salesforce to market and distribute the SCD to nephrologists and intensive care physicians specializing in pediatric extracorporeal therapy.

Nestor Jaramillo, Jr., President and CEO of Nuwellis, expressed his excitement about this regulatory update, emphasizing the importance of bringing this lifesaving therapy to the pediatric clinical community. The approval of SeaStar’s SCD-PED will address a critical need, as approximately 4,000 children in the U.S. with AKI require CKRT each year, with a mortality rate of approximately 50%. Survivors of AKI episodes are also at risk of long-term conditions such as chronic kidney disease (CKD).

Nuwellis, with its focus on transforming patients’ lives through science, collaboration, and innovation, is dedicated to commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. The company, headquartered in Minneapolis, Minnesota, operates a wholly owned subsidiary in Ireland.

The Aquadex SmartFlow® system offers a clinically proven method of removing excess fluid from patients suffering from hypervolemia (fluid overload). It is indicated for temporary or extended use in adult and pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management. All treatments must be administered by healthcare providers within outpatient or inpatient clinical settings, under physician prescription, and after receiving training in extracorporeal therapies.

Looking ahead, Nuwellis anticipates new market opportunities and significant growth in 2023 and beyond. However, the company acknowledges the potential impact of the ongoing COVID-19 pandemic and other factors that may affect its commercialization strategy and operations.

Nuwellis remains committed to advancing its product development and commercialization efforts, increasing market acceptance, and enhancing physician confidence in its products. The company also recognizes the importance of protecting its intellectual property and integrating acquired businesses to drive synergies and benefits.

As Nuwellis and SeaStar continue their collaborative efforts, this regulatory milestone brings hope for improved outcomes for children with AKI and sepsis. The potential approval of SeaStar’s SCD-PED will undoubtedly contribute to the advancement of pediatric extracorporeal therapy, providing a much-needed solution for patients and healthcare providers alike.