SeaStar Medical Holding Corporation (NASDAQ:ICU) has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Selective Cytopheretic Device (SCD). The device is intended to treat chronic systemic inflammation in patients with end-stage renal disease (ESRD) who require chronic hemodialysis. This designation aims to expedite the development and review process for the SCD, offering potential benefits to a patient population with significant unmet needs.
Addressing Chronic Inflammation in ESRD
Chronic hemodialysis patients, numbering over 480,000 in the U.S., face a high disease burden, including chronic fatigue and frequent hospitalizations, resulting in a five-year survival rate of only 42%. The SCD, a first-in-class cell-directed therapy, targets dysregulated immune responses in these patients. By modulating the immune system, the SCD aims to improve survival rates and overall quality of life.
Kevin Chung, MD, Chief Medical Officer at SeaStar Medical, emphasized the potential of the SCD to safely and effectively address chronic systemic inflammation, a major contributor to poor outcomes in ESRD patients. The company's goal is to demonstrate that concurrent SCD therapy can improve survival and clinical outcomes for patients undergoing chronic dialysis.
Mechanism of Action
The SCD functions by targeting proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT), transitioning them to a reparative state and reducing inflammation. This approach differs from other blood-purification tools by focusing on immunomodulation, potentially promoting long-term organ recovery and reducing the need for future renal replacement therapies.
Expedited Development and Review
The Breakthrough Device Designation is expected to expedite the development and review process for the SCD. This designation grants SeaStar Medical priority review by the FDA, early patient access, and potential for differentiated market positioning. This is the fourth such designation for SeaStar Medical's SCD, potentially expanding its addressable patient population in the U.S. to at least 745,000 annually.
SeaStar Medical's Broader Portfolio
SeaStar Medical's portfolio includes applications of the SCD for conditions associated with excessive inflammatory responses, such as sepsis and acute kidney injury. The company focuses on cell-directed extracorporeal therapies, aiming to redefine the impact of extracorporeal treatments on vital organs affected by inflammation.
Recent Developments
SeaStar Medical recently settled a dispute with Nuwellis over a distribution agreement for its pediatric SCD product, agreeing to pay Nuwellis $900,000 by December 31, 2024. The company has also reached a milestone in its NEUTRALIZE-AKI trial, with 51 participants enrolled, surpassing the halfway mark of its 100-subject interim analysis goal. Trial sites have expanded to include Brooke Army Medical Center and the United States Army Institute of Surgical Research, bringing the total number of clinical sites to 11. SeaStar Medical has also reported the full retirement of its long-term debt and announced a $10 million stock and warrant sale.
