SeaStar Medical, a company developing solutions to lower the consequences of hyperinflammation on vital organs, was awarded U.S. Food and Drug Administration (FDA) Breakthrough Device Designation.
 
The company’s cell-directed Selective Cytopheretic Device (SCD) was granted breakthrough device status to be used in the ICU for acute or chronic systolic heart failure and worsening renal function due to cardiorenal syndrome or right ventricular dysfunction awaiting implantation of a left ventricular assist device (LVAD).
 
The SCD selectively targets the most highly activated proinflammatory neutrophils and monocytes. The company said it has observed these most highly activated immune cells are switched off in a low-calcium environment. The SCD therapy mimics nature by creating a unique micro-environment, attracting the highly activated effector cells and neutralizing them. These cells are then returned back into the body through the blood, and the body is signaled to focus on repair.
 
“Cardiorenal syndrome is seen in the most severe cases of heart failure and is associated with a very poor prognosis,” SeaStar Medical’s chief medical officer Kevin Chung, MD told the press. “The SCD is able to halt the downward spiral often perpetuated by a hyperinflammatory state driven by the innate immune system, giving these patients a fighting chance.”
 
In addition to preclinical data, the company’s breakthrough device submission included a first-in-human study under an NIH grant to the University of Michigan, where a patient with severe chronic heart failure, ineligible for heart transplantation or LVAD implantation, was treated with the SCD. The patient reached the primary endpoint of a successful LVAD implantation and was sent home.
 
The procedure was deemed to be safe and there weren’t SCD-related adverse events, which was consistent with other clinical trials in critically ill adults and children with acute kidney injury (AKI) and multi-organ failure, SeaStar said. In 2022, the SCD earned breakthrough status for adult AKI.
 
“We believe the SCD represents a novel, innovative and transformative approach to treating hyperinflammation in severely ill patients with chronic heart failure. Receipt of Breakthrough Device Designation in adult AKI previously and now in cardiorenal syndrome, coupled with highly promising data from studies across multiple disease conditions, strengthens our position that the SCD’s proprietary mechanism of action of targeting dysregulated immune responses is organ-agnostic, with potential applicability in multiple high-value, unmet medical needs where hyperinflammation plays a role,” SeaStar Medical’s CEO Eric Schlorff said. “We plan to work in partnership with the University of Michigan to conduct a larger clinical study in the same patient population to gather additional evidence to support the submission of a Premarket Approval (PMA) application to the FDA.”
 
Earlier this year, SeaStar began an exclusive agreement with Nuwellis to license and distribute the SCD in the U.S.